QC Analyst Resume Samples

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M Sanford

Manley

Sanford

35646 Kirlin Bypass

New York

+1 (555) 459 1697

35646 Kirlin Bypass

New York

Phone

p +1 (555) 459 1697

Experience Experience

Boston, MA

QC Analyst

Boston, MA

Rowe, Jast and Legros

Boston, MA

QC Analyst

Establish new and improved ways to perform job by challenging established procedures
Assist in the development and improvement of written procedures
Revise and update minor changes to testing procedures, work instructions, and worksheet for correction or process improvement
Work within current EHS guidelines and provide input into EHS improvements within the QC laboratory and elsewhere on site
Contribute to improvements in laboratory activities especially in respective individual work areas
To plan and execute all work in an accurate, efficient and timely manner
Assist in maintaining a clean, safe workplace on a daily basis

Philadelphia, PA

QC Analyst, Hour Rotating Night Shift

Philadelphia, PA

Rath LLC

Philadelphia, PA

QC Analyst, Hour Rotating Night Shift

Assist in the development and optimization of testing methods
Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines
Perform Biological Indicator Testing
Perform Environmental Monitoring
Perform Endotoxin Testing (Gel Clot and Kinetic Turbidimetric)
Perform routine Quality Control testing of in-pro0cess and final products in a cGMP lab for release
Perform Bioburden Testing of In-Process products, buffers, and water

present

Detroit, MI

Senior Qc Analyst

Detroit, MI

Franecki, Gutmann and Schumm

present

Detroit, MI

Senior Qc Analyst

present

Establishes working relationships across functions. Employs internal working relationships to influence business objectives
Advise Test Manager/Project Manager regarding overall quality of project and state of work
Identify and drive the development and implementation of activities to improve Turn-around-time (TAT) and operational excellence
Constantly review procedures and processes and work closely with key internal partners to improve QC efficiency
Participate in development and validation of automated sample prep workflows and automated spreadsheets for data analysis
Raise outstanding issues through established project management channels, as per project plan
Ensure consistent feedback to production management as it relates to quality and escalation to Senior Management when no corrective actions occur

Education Education

Bachelor’s Degree in Chemistry

University of California, Los Angeles

Bachelor’s Degree in Chemistry

Skills Skills

Basic knowledge of lab safety and the ability to work safely with chemicals of varying potency
Proficient use of Microsoft Office and ability to quickly learn and utilize various web-based applications, databases and mainframe applications
Good computer skills, including proficiency with business and technical software (Word, Access, Excel, PowerPoint, SAP, TrackWise, Empower, SAP)
Good time management and attention to detail
Strong analytical ability and associated problem solving skills
Strong attention to detail
Excellent computer skills; especially proficient in Excel and Word
Knowledge on quality and food safety system
Has good planning and organising skills with ability for problem solving
Pays attention to detail and ensures high quality work

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Consumer Credit Risk Qc Analyst Resume Examples & Samples

Determines the potential causes of any deficiencies noted throughout the course of the audit. Tracks and escalates trending concerns to QC Manager or Director
Completes investigation referrals for submission to Bank Protection upon discovery of any suspicious activity. Assists in any follow up research to assist the investigation
BachelorÆs degree or equivalent experience in mortgage/consumer credit or quality control
Minimum 4 years experience with Freddie Mac and Fannie Mae automated underwriting systems (LP and DU)
Knowledge of the fundamental concepts related to mortgage and consumer loan origination, process, underwrite, and closing and the ability to apply that knowledge in an audit function
Knowledge of the BankÆs, InvestorsÆ, Government and Underwriting Program requirements
Good Computer skills with intermediate proficiency in Microsoft Outlook, Word, Excel and Access (or equivalent database reporting programs)
Ability to work efficiently with a low margin of error

QC Analyst Resume Examples & Samples

40-50% Testing execution
30-40% QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
10-20% Compliance and quality systems (SOP revisions, input to quality systems records)
10-20% Participate in training analysts; troubleshooting of test methods

QC Analyst Resume Examples & Samples

60%: Testing execution
30%: QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
10%: Compliance and quality systems (SOP revisions, input to quality systems records)

QC Analyst Resume Examples & Samples

Bachelor of Science or Bachelor of Arts in a Biological or Biochemical Science with at least 0-2 years of relevant laboratory experience or Associates of Science with at least 4 years of relevant laboratory experience
QC cGMP experience beneficial
Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices
Ability to perform most tasks with supervision
Experience with Microsoft Word and Excel required; experience with Access and PowerPoint a plus
Experienced with microbiological methodologies and a variety of analytical instrumentation; capable of troubleshooting assays
Efficient in scheduling and facilitating the execution of routine and non-routine testing

QC Analyst Resume Examples & Samples

At least one year in a cGMP/GLP laboratory; quality control experience beneficial
Ability to perform tasks with direct supervision
Experience with Microsoft Word and Excel are required
Must have excellent record keeping, written, and verbal skills
Required to work in a GMP laboratory and GMP manufacturing clean room area and comply with the work requirements and procedures of these specialized areas
May work with biohazardous materials and/or hazardous chemicals
The employee must occasionally lift and/or move up to 50 pounds
Close supervision and guidance may be necessary for specific ad hoc assignments
Must have a quality service attitude and be willing to work additional hours to meet production requirements

Kyc Qc Analyst Securities Resume Examples & Samples

2 years experience CIP/KYC/AML Area
Expertise in/familiarity with brokerage processes and systems would be helpful
Knowledge of rules and regulations applicable to money laundering, including the Patriot Act, and OFAC requirements
PC Proficiency: Advanced/Intermediate level of Microsoft Excel, Power Point and Word
Ability to handle deadlines
Ability to work independently in a fast-paced/high-pressure environment
Strong writing and analytical skills
Self-starter, organized, detailed-oriented and ability to work independently

Senior QC Analyst Team Lead Resume Examples & Samples

Working as directed by Laboratory Management according to Company safety policies, cGMP and cGLP
Formulating weekly work schedules with the Laboratory Management and ensuring that these schedules are communicated and followed
Checking raw materials, in-process and finished product work
Trending of raw materials, in-process, finished product results
Ensuring results are recorded in a timely and accurate fashion
Reviewing analyst documentation and ensuring Right First Time KPIs are achieved
Issuing monthly / annual reports to the Laboratory Management
Trouble-shooting within the QC Department and providing technical assistance / support to other Departments
Maintaining laboratory SOPs and specifications in a state of compliance
Assisting with out of specification investigations
Training of QC staff and regular review of training records. Involvement in QC equipment projects including purchasing and ensuing validation
Working on projects as detailed by Laboratory Management
Representing the QC Department on site/inter departmental projects
Performing any other activities as indicated by the Laboratory Management
At least 4 years experience working within a cGLP environment (IMB and FDA approved)
A minimum of 2 years supervisory (team leading a team of 3-5 analysts) experience within a lab environment with a proven track record of effectively scheduling & delegating Analysts' work.A BSc in a related discipline is a must
Extensive experience with HPLC, IC & GC is required (Desired Level: Subject Matter Expert)
Ability to critically review analytical data. Possessing excellent attention to detail is a must
Ability to advise, lead and manage a small team of analysts
Experience of preparing for regulatory audits
The ability to work well with all key contacts both internal and external to the organisation
Prior experience of implementing training modules

Homeowners Assistance Qc Analyst Resume Examples & Samples

As assigned, audits routine workout loans to confirm that mortgage processes have been performed in accordance with the Bank's and Investor Requirements, Government Regulations and the Bank's Quality Control Program
Documents work performed; records deficiencies discovered throughout the course of the audit and evaluate the quality of the files audited
Records the evaluation in Quality Control database for future compilation into a management report
Determines the potential causes of any deficiencies noted throughout the course of the audit
Prepares a clear, concise report of significant findings on a file-by-file basis, to be distributed to appropriate internal parties
Collaborates with other Quality Control personnel and provides research support for findings reported to management
May assist in the preparation of a report on the audit sample, making recommendations for appropriate corrective actions to reduce or prevent the occurrence of similar deficiencies in the future
Interacts with more senior-level Quality Control Analysts to further develop auditing and investigation skills and overall mortgage knowledge

Qc Analyst Senior Resume Examples & Samples

Minimum 4 -years advanced level mortgage or consumer bank underwriting experience. Including previous quality control experience or advanced level loan processing experience that required underwriting decision authority
Minimum 4 years FHA/VA mortgage underwriting, high level processing, or quality control experience
Ability to work independently and meet deadlines

BSA QC Analyst Resume Examples & Samples

.Current Certified Anti-Money Laundering Specialist (CAMS) Certification
.Minimum of 3 years experience or knowledge of BSA regulations concerning KYC, EDD, Financial crime investigations and regulatory reporting
Represents the basic qualifications for the position. To be considered for this position you must at least meet the basic qualifications

QC Analyst Resume Examples & Samples

B.S. in a life sciences discipline
1+ years of experience in GMP and/or GCP and/or GLP environment
Understanding of cGMPs and/or GCPs and/or GLPs and their application to a wide variety of problems and situations
Strong communication and technical writing skills in the English language. A second language is a plus

Kyc Qc Analyst Ii Business Banking Resume Examples & Samples

Knowledge of financial and economic concepts including cash flow and wire transfers; knowing current economic and fraud trends and AML priorities; understanding how cash flow and transactions may vary by industry
Independent, self-motivated and a team player
Proficient in MS Office applications, especially Excel

Qc Analyst Hplc Resume Examples & Samples

40-50%: Testing execution
30-40%: QC operations support which entails data review, data trending, OE initiatives, maintenance of equipment and reagents, lab housekeeping, support for other QC groups (if necessary)
10-20%: Compliance and quality systems (SOP revisions, input to quality systems records)
10-20%: Participate in training analysts; troubleshooting of test methods
Repetitive bending and reaching to setup and break-down equipment

QC Analyst Resume Examples & Samples

Support the QC laboratory to facilitate manufacturing facility start up. This involves participation in method transfers, qualification of clean rooms and clean utility qualification testing
Perform, microbiological/biochemical/physical/chemical analyses of QC test samples under cGMP to meet specified timelines
Perform environmental monitoring and clean utility sampling and analysis
Evaluate results against defined acceptance criteria
Perform primary review of QC raw data and trend results
Prepare protocols, summaries, and reports-often for direct submission to pharmaceutical regulatory agencies
Develop, optimize, validate and troubleshoot analytical test methods
Draft QC SOPs
Act as technical resource and train other analysts in areas of expertise
Maintain the laboratory in an inspection-ready state. Interact directly with regulatory agency inspectors during audits
Conduct and document laboratory investigations
Interface with other BioMarin departments (Manufacturing, Quality Assurance, Facilities, etc.) and contractors as necessary
3 years of relevant laboratory experience
Ability to work independently and meeting established timelines

QC Analyst Resume Examples & Samples

HPLC
ELISA
RT-PCR
Cell based bioactivity testing
Routine maintenance of mammalian cell lines
Capillary Electrophoresis cSDS, cIEF
Gel Electrophoresis e.g. SDS-PAGE, IEF
Collaboration and team work
Maintains the highest standards of ethical behaviour
Clear communication skills
Holds self-accountable for compliant and flawless execution
Problem solving and attention to detail
Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise etc

QC Analyst Resume Examples & Samples

Prior experience with non-routine projects
Prior experience dealing with raw materials
TOC method development experience
Risk Assessment experience
Microbiology or Chemistry experience

Homeowners Assistance Qc Analyst Resume Examples & Samples

Associate's Degree or equivalent combination of training and experience in related field
Minimum one-year advanced level mortgage banking experience in assigned quality control area, such as default or servicing
Knowledge of the fundamental concepts related to mortgage default and the ability to apply that knowledge in an audit function
Knowledge of the Bank's, Investor's, Government and Underwriting Program requirements
Knowledge of all documents used by the Bank in the origination of FHA, VA and conventional loans
Computer literate with intermediate proficiency in Microsoft Outlook, Word, Excel and Access (or equivalent database reporting programs)

QC Analyst Resume Examples & Samples

4-year Science degree
Raw material testing experience
QC Analyst and Lab Testing experience

KYC QC Analyst Resume Examples & Samples

Minimum of 3 years of related KYC/AML experience required, including relevant Audit, Legal, and Compliance experience
Knowledge and understanding of Consumer and Business Banking and client base
Excellent written communication skills. Ability to review a written assessment and provide quality feedback on the soundness and completeness of the analysis
Ability to use sound judgment to determine due diligence quality and appropriate escalation steps if necessary
Strong time management, organizational, planning and follow-up skills; ability to multi-task effectively
Strong interpersonal and verbal communications skills; ability to partner with internal partners and leverage internal resources
Ability to use various PC and internet applications and tools to support the KYC process

QC Analyst Resume Examples & Samples

To observe GLP/cGMP at all times
Testing of all laboratory samples including Raw Materials, Packaging Components, Product, Validation, Stability, Environmental, OH and Purified Water
Performance of laboratory tests as per written procedure or as per pharmacopoeia
Recording of analytical results accurately
Operation, maintenance and calibration of laboratory instruments
Preparation and execution of instrument and method validation protocols
To maintain written training records
To ensure that the laboratory is kept clean, tidy and safe at all times
To report any non-conformance, instrument malfunction, accident or other abnormal occurrence to immediate superior
Ordering, receiving and controlling laboratory chemicals, reagents and consumables
Receiving and controlling test samples
Participate fully in cross functional training
Drive and promote the corporate values within the workplace
Participate in and facilitate improvement programs within the department/workplace
Any other duties as required and assigned from time to time by the Director of Quality or other officer appointed by the Board of Directors
BSc. (minimum) in analytical science or a related discipline
Have relevant experience in the pharmaceutical industry
Have a minimum of 1-2 years industry experience in an analytical lab
Have good organisational, communication, interpersonal and report writing skills
Is adaptable to changing priorities

QC Analyst Resume Examples & Samples

Responsible for supporting the implementation of a process mapping framework that will enable an end to end view of the business process and control environment
Responsible for the supporting the implementation of a CCB wide tool with a design that delivers usability and adoption to ensure sustainability of process mapping investment
Responsible for supporting the QC Lead in creating the standard Process Mapping and Modeling methodology and taxonomy to ensure consistency and integrity of process input and information
Responsible for QC of all process mapping activity, maintaining data integrity of the inputs and changes
May assist in coaching and training activities for line of business users of the process management tool
Responsible to proactively and periodically reviewing processes relative to their risk level and rate of change
Responsible to implement appropriate change management safe-guards and standards to ensure process mapping is integrated into change initiatives at the on-set
In partnership with the functional control officer team, recommend additional control measures as gaps are identified
Integrate with other control agenda work-streams to provide a comprehensive solution that delivers a comprehensive control framework across RCSA, Third Party Oversight, NBIA/Change Management, Issue Management, etc
Understanding of internal consulting, process re-engineering and change management roles within the financial services industry
BA/BS in related field
Experience in contributing to large scale, cross LOB process improvement and change management projects or programs
Experience with process mapping
Experience with using Business Process Management Tools, preferably iGrafx
Excellent communication skills including exceptional facilitation and presentations skills and ability to train and influence
Performs well in a team environment and proactively collaborates with others
Ability to interact effectively with all levels of management, including cross-functional and external stakeholders
Ability to work well in a fast-paced environment
Must be a self-motivator and be able to work with minimal direction
Must have a positive, can-do attitude

QC Analyst Resume Examples & Samples

Achieves competency in CBIL laboratory methods and procedures
Trains other QC analysts in laboratory methods and procedures when required
Performs analytical testing activities in relation to method validation and technical

AM, QC Analyst Resume Examples & Samples

Review Know Your Client reports (KYCs) and identify parties that need to be researched by the Global Due Diligence Operations team
Liase with front office banker teams to determine the proper level of research needed for clients and/or entities depending on the title/qualification/position/ownership level
Compile names/findings into a standardized report and forward to the Global Due Diligence Operations team
Summarize and communicate derogatory information in written form
Properly identify risks and escalate derogatory/high risk findings to Senior Management; risks include but not limited to – PEP, High Risk Jurisdictions and Specially Designated Nationals (SDN) / Office of Foreign Assets Control (OFAC) matches
Research, analytical and comprehension skills, with ability to analyze and summarize large amounts of data quickly and efficiently
Strong verbal and written skills to clearly articulate and document alert disposition
Well organized, self starter
Demonstrated ability to multi-task and meet deadlines in high -pressure environment
Flexible and adaptable to changing work processes
Proficient in MS Office; strong typing skills
Knowledge of Compliance, KYC/Due Diligence and/or investigation experience
Fluency in Spanish or Portuguese
Familiarity with public records
Relevant course work in criminology, law and logic

QC Analyst Resume Examples & Samples

Working as directed by the Area Supervisor, in accordance with Company safety policies, cGMP and cGLP
Receiving and logging samples into the Laboratory
Analysing raw material, in-process, finished product and stability samples associated with development products according to specifications, primarily HPLC and dissolution
Analysing validation samples according to validation protocols and investigational samples as directed
Recording results in a timely and accurate fashion
Ensuring the Right First Time KPI with respect to Analyst's documentation are achieved
Reviewing co-workers/analyst documentation (i.e. Buddy System)
Ensuring that all Quality Systems within the department are adhered to on a daily basis
Ensuring correct labelling of laboratory reagents and samples
Troubleshooting any erroneous analytical data obtained (Involvement in Lab Investigations Reports)
Helping to ensure laboratory SOPs and specifications are kept up to date and in a state of compliance
Training other laboratory staff as requested and appropriate

QC Analyst Resume Examples & Samples

Degree in analytical science or a related discipline
Minimum of 1-2 years industry experience in an analytical lab
Experience in any or all of the following is essential: HPLC, GC, Dissolution, Wet Chemistry

Senior Qc Analyst Resume Examples & Samples

30-40%
Ability to work around chemicals
Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases
Ability to walk and stand for periods of time
Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

Senior Qc Analyst Resume Examples & Samples

Provide expertise in a variety of analytical test procedures
Plan and prioritise scheduling tasks for other analysts within the QC laboratory
Carry out sampling and analytical testing of raw materials, packaging materials, intermediates and finished API product according to approved procedures and plant schedules, when required
Ensure that all testing information is recorded accurately and completely according to procedures
Provide guidance in deviation investigations, OOS investigations, change proposals and batch disposition
Provide samples to contract testing laboratories and liaise with these laboratories as required
Ensure analysts are adequately trained as per SOP's
Lead method transfer and method validation projects as required
Review equipment qualification documentation for QC Laboratory equipment
Participate in the cleaning validation programme
Contribute effectively to the design and implementation of quality systems in the QC laboratory to meet the requirements of ICH Q7A
Work with other QC personnel in the preparation and review of the required documentation in the QC laboratory, including Standard Operating Procedures, Analytical Procedures, Analytical Worksheets and Material Specifications

QC Analyst Resume Examples & Samples

Aide in the setup of a new QC laboratory
Input into the purchase and installation of new equipment - oversee IQ/OQ where applicable
Draft and review documentation - SOPs, protocols, training modules, investigations, reports and Trackwise documents
Actively participate in analytical method transfers and method validations as required
Conduct and document out-of-specification/out-of-trend result investigations
Responsible for the day to day running of the QC laboratory
Experience with wet chemistry, GC, HPLC, Electrophoresis, ELISA and a willingness to learn new analytical techniques as the laboratory evolves
Work within the test schedule for the facility and the stability programmes
Day to day activities required for running of the laboratory

QC Analyst Resume Examples & Samples

BSc Degree in Life Science or related
Minimum of 2 years' work experience working within a pharmaceutical cGLP environment (IMB and FDA approved)
Experience with: HPLC, IC & GC testing methods
Ideally the successful candidate will have worked in an R&D environment with dissolution experience

Mortgage Banking QC Analyst Resume Examples & Samples

Input all review results in the QR Database and communicate results back to the business
Attend all training sessions to ensure full understanding of testing criteria
Quality control, processing, or closing experience
2+ years audit, quality or mortgage banking experience required
Plus 2 years in processing, closing or underwriting experience

QC Analyst Resume Examples & Samples

Minimum BSc in Science or equivalent
Minimum 5 years' experience in a similar role
Solid experience of GC required ELISA, cell based experience desirable
Experience with method validation/ method development
Good computer skills, including proficiency with business and technical software (Word, Access, Excel, PowerPoint, SAP, TrackWise, Empower, SAP)

QC Analyst Resume Examples & Samples

Reviewing co-workers/analyst documentation
BSc Degree (life science)
Minimum of 1 years' work experience working within a pharmaceutical cGLP environment (IMB and FDA approved)
Practical/Working experience of HPLC, IC & GC testing methods
Possessing excellent attention to detail is a must with ability to critically review analytical data
Ability to trouble shoot, identify analytical issues and follow up with corrective actions

QC Analyst Resume Examples & Samples

Independently gather information from source systems and execute test steps to efficiently and accurately identify control weaknesses; summarize and document results for management
Apply critical thinking skills to evaluate and provide feedback on control designs, test procedures and test results
Productively advise control procedure owners on test results
Collaborate with Loan Services’ process owners and risk partners to achieve results aligned with a strong control environment
Independently and accurately calculate and enter interest rates into the appropriate lending systems on a periodic basis
Possess basic interpersonal skills with an ability to collaborate with Loan Services’ process owners and risk partners to achieve results aligned with a strong control environment
Basic organizational skills and ability to manage and prioritize multiple assignments
Possess basic knowledge of RCSA testing methodology and documentation
Developing subject matter expertise for compliance and operational risks and control activities within lending processes
Developing knowledge of RCSA framework, including inherent risk, management control effectiveness and residual risk
Bachelor’s Degree or equivalent work experience with emphasis on lending and risk management
1+ years of risk management, audit experience or 3+ years of lending experience

QC Analyst Resume Examples & Samples

Carry out routine analysis on Finished Product and Shelf –life samples ensuring compliance with cGLP/cGMP and that turnaround times are met. The testing carried out includes but is not limited to: HPLC, Osmolality, Organic Iodine, Inorganic Iodide, Thin Layer Chromatography, pH, RI, Particulate matter, Technical tests, Extractable volume, Inductively coupled plasma
Assisting in the maintenance of the shelf-life monitoring program
Actively involved in investigations e.g. LIR’s. PLI’s, etc
Logging of samples in LIMS
Entering results on LIMS, checking results are within specification and also task approval
Support continuous improvement in the lab through operational excellence / lean lab initiatives
Support the maintenance of the Certified Lean laboratory status of the FP laboratory
Ensure compliance with EHS at all times, actively participate in EHS activities
Perform routine instrument calibration checks at appropriate times
Preparation and control of Standard Operating Procedures and ensuring compliance with cGMP guidelines at all times
Completion of Documentation for Batch Release process
Assisting in the provision of trends
Assist in audits
Generation/ reporting of Key performance indicators for the group
Be proactive in approach planning for future and implement improvements in an effective manner
Develop areas of expertise in analytical testing in order to solve technical issues
Ensure compliance with current pharmacopoeias and all regulatory/company guidelines
Interaction with other departments as required
Keep colleagues informed of current issues and developments as appropriate
Assist in the training and up skilling of colleagues
Reasonable level of overtime will be required to facilitate the business needs
Hold yourself and peers accountable to responsibilities of this role
Carry out additional duties as deemed necessary by the QC Manager/Group Leader
A third level science qualification or equivalent
Flexibility and agility
Openness to change
Proven ability to work on own initiative
Experience in a regulated pharmaceutical laboratory desirable though not essential

QC Analyst Resume Examples & Samples

Water testing experience is also required
BSc in Science or advanced degree preferred
Sterile manufacturing and/or biotech experience is preferable
Pharmaceutical drug/process development experience preferable
Good technical and compliance-based writing skills

QC Analyst Resume Examples & Samples

Initiating and maintaining mammalian Cell Culture
Process Impurity testing e.g. ELISA, Resuisudal DNA, Host Cell Protein
Cell based Bioactivity Testing
Experience with liquid handling systems e.g. TECAN
Holds self accountable for compliant and flawless execution
Experience with electronic systems such as LIMS, Electronic Lab notebooks, Empower, Trackwise etc,

QC Analyst Resume Examples & Samples

Conducts analyses concerning the microbiological aspects of drug products, components and processes for purposes of product and process development, quality control, quantitative and qualitative analysis
Test samples to ensure compliance with FDA and cGMP requirements according to approved written procedures and specifications
Prepares test data for appropriate review. Documents the procedures and results obtained in laboratory notebooks/LIMS according to established regulatory guidelines
Maintains cultures, standards and reagents in accordance with written procedures
Cultivates isolates and assists in identifying bacteria and other microorganism contaminants
Analyzes microorganisms growth, structure, development and general characteristics of bacteria, yeast and molds as related to their actions on drug products, components, equipment and processes
Prepares and performs functions utilizing aseptic techniques, including but not limited to, Environmental water and water sampling, testing and analysis, media growth promotion testing, sterility testing, microbial limits testing, microbial antibiotic assay testing, antimicrobial effectiveness testing, and relevant validation testing according to approved written procedures and specifications
Works on special projects and validations, as required
Perform fogging and maintenance of the Sterility Test Area, as required
Perform data entry and peer review of environmental data. Present graphical data, analyze data and assist with environmental trend reports as per schedules
Assist associates with more complex microbiological tests and projects, as required
Collect required monthly calibration items used in analyses, such as thermometers, stopwatches and timers; assist with calibration as required
Reviews department SOPs for accuracy and provides revisions as required
Track supplies and restock inventory in store rooms. Maintain stock / store rooms, as required
Receives and verifies receipt of laboratory samples for accuracy, documents receipt of samples in appropriate logbook and returns sample submission sheets to initiating department (manual entry and LIMS receipt). Create and receive LIMS for stabilities
Assist with general lab duties/functions and housekeeping in all Microbiology Laboratory areas, as required

QC Analyst Resume Examples & Samples

Carry out testing of drug substances and drug products in accordance to the valid testing procedures and regulatory requirements
Ensure that laboratory equipment is well maintained and calibrations are carried out at the designated frequencies
Review results generated by other analysts for compliance with requirements
Ensure correct data entry to LIMS
Ensure that all target dates are met
Maintain laboratories to a high housekeeping standard
Carry out method transfers and participate in the validation of analytical test methods as required
Write and maintain necessary documentation (test protocols, SOPs, instrumentation manuals and checkout sheets, method transfer reports, OOS reports, etc.) according to the existing SOPs and cGMP standards

QC Analyst Resume Examples & Samples

BSc In science related field with (min) 4 years’ experience in pharmaceutical manufacturing
Strong technical knowledge of microbiological test instrumentation and method development / validation including software/computer system validation
Excellent organizational, planning and scheduling skills: Capable of managing/coordinating priorities in a dynamic environment, while maintaining a professional demeanor
Critical, Fact-Based Decision Making: Demonstrates a systematic approach to problem solving; considers all relevant facts & data when making decisions; applies previous experience & best practices to new situations
Good verbal and written communication skills; confident presenter, clear, concise technical writer
Own specific aspects of a project, propose solutions for difficult problems, execute project tasks
Write, revise or review equipment and method qualification protocols/reports, engineering studies, SOP’s and specifications
Write deviation investigation reports and audit responses
Manage relationships with equipment vendors and contract laboratories
Perform backup support microbiological testing activities as needed
Participate in compliance audits, investigations, and CAPA implementation. Participate in resolution of microbiological excursions
Develop and maintains effective working relationships with key internal/external customers

QC Analyst Resume Examples & Samples

Perform QC testing
Work in accordance to cGMP and GLP requirements
Maintain a high standard of Safety and Housekeeping in the Laboratory
Maintain proper records and generate reports in line with operational and regulatory requirements
Organise/Plan/Schedule own daily work schedule for assigned work in the absence of the Analyst 4 / Team Lead or as part of a specific project
Review and update of documentation, e.g. SOP’s and Analytical Protocols
Trending and review of results in timely manner ensuring KPIs are met e.g. In Process/Finished Product
Lead laboratory investigation root cause analysis; manage technical issues and completion of LIRs/Deviations as appropriate
Recognise and take ownership of technical issues and make necessary decisions
Preparation of reports including validation protocols and reports
Train and mentor new analysts
QC Lab representative / SME on Alkermes technical projects. Deliver technical projects according to timelines
Ensure all instruments and equipment is maintained in a calibrated and operational state
Represent the Company at audits, client visits when required to do so
Perform and assist in additional duties

QC Analyst IV Resume Examples & Samples

BSc In science related field with (min) 6 years’ experience in pharmaceutical manufacturing
Able to work autonomously, receiving general instructions on new assignments
Strong technical knowledge of microbiological test instrumentation and method development / validation including software/computer system validation. Some experience in analytical chemistry techniques (e.g. HPLC/GC) is of benefit
Experience with the execution and validation of microbiological test methods for sterile and non-sterile drugs, their raw materials, components and in-process testing. This includes the methods described in USP Chapters 61, 62, 71, 85, 788, 790 and relevant informational chapters
Excellent organizational, planning and scheduling skills: Capable of managing/coordinating multiple projects and priorities in a dynamic environment, while maintaining a professional demeanor
Personally Accountable: Owns the results of their individual actions & team activities. Ability to learn from mistakes & holds a strong belief in continuous improvements, both personally & professionally
Agility: Able to quickly change direction when business priorities or customer requirements change; exhibits a high level of flexibility when confronted with new or unexpected circumstances
Familiar with common MS Office software packages
Lead specific aspects of a project, guide solutions for difficult problems, execute project tasks. Identify best solutions based on project requirements
Write, revise or review equipment and method qualification protocols/reports, engineering studies, SOP’s, specifications, and assigned sections of regulatory filings
Write or review deviation investigation reports and audit responses
Establish and manage relationships with equipment vendors and contract laboratories
Serve as subject matter expert for training, operation and troubleshooting of select laboratory instrumentation
Serve on special committees and project teams
Performs backup support microbiological testing activities as needed
Participates in compliance audits, investigations, and CAPA implementation. Participates in resolution and approval of microbiological excursions
Supports manufacturing and validation activities including Aseptic Process Simulations/Validations and Cleaning Validations
Develops and maintains effective working relationships with key internal/external customers

Senior Qc Analyst Resume Examples & Samples

In addition to the routine support activities, the position will be responsible for the more complicated lab techniques, and will be expected to independently complete major projects and programs
Introduce new technologies into the laboratory as required. Update current methods as necessary using the Change Control system
Draft, review, and edit relevant CMC sections for IND submissions
Complete testing and report writing on Raw Materials, In Process Materials, Final Products, Stability Samples, Process Development Samples, Investigational Samples, and Degradation Samples on all methods contained within the QC Analytical group
For a selected set of lead methods, the analyst will be responsible to independently control and trend all aspects of the method to ensure consistent performance of the method, including reviewing runs completed by other analysts, troubleshooting the method when necessary, and compiling statistics in order to assess if the method is performing properly
Responsibility to interpret complex analytical results, troubleshoot methods, complete development, optimization, and qualification work (protocol drafting, data collection, and report writing) independently
The analyst may oversee both the training and development of junior level analysts. This includes training in analytical techniques as well as critical thinking
The analyst will act independently to determine the most efficient path and method to the new assignments and direct the necessary resource to get the assignment completed
Recognize results that deviate from established standards, specifications, and trends, and independently recommend appropriate actions. Perform testing necessary to investigate out-of-specification test results. Complete Deviation/OOS reports including corrective and preventive actions independently
Complete general lab maintenance and administration tasks including but not limited to sample handling, tracking, shipping. Also, reserve and stability sample tracking, monitoring, reconciliations, and processing
Position requires science degree in Biochemistry or related discipline with no less than 7 years of relevant experience in the Biotechnology industry with emphasis in quality control (QC) testing
Working knowledge of QC testing requirements, methodology and equipment such as HPLC, ELISA, and basic chemistry
Strong in charge based assays (IEX-HPLC, icIEF method)
Strong on troubleshooting and problem solving skills
Must be a great independent thinker, can apply the knowledge and concept quickly and effectively to different areas
Strong knowledge of MS Word and Excel
Good interpersonal, communication, organizational skills
Require knowledge of cGMP, FDA, and USP regulations and a basic understanding of statistics
LI-EP

QC Analyst Resume Examples & Samples

Perform accurate analytical testing as well as equipment verifications in accordance to procedures or SOPs
Document all results in accordance to GMP / GLP requirements
Ensure all quality records are attached and/ or filed as predetermined
Practice laboratory good housekeeping and ensure all safety procedures are followed
Participate actively and contribute to teams / projects (eg. 5R etc.)
Contribute to improvements in laboratory activities especially in respective individual work areas
Perform simple equipment troubleshooting

Senior Qc Analyst Resume Examples & Samples

Work schedule for this position is Monday-Friday, with availability for occasional remote support on weekends (production runs 7 days per week)
Manage and execute projects around QC process improvements and qualification of changes using project management tools to achieve timelines on multiple projects with a high level of independence
Excellent cross-functional collaboration, soft influence, written and verbal communication skills
Understanding of medical device quality system requirements (21 CFR 820, ISO 13485, etc.) in appropriate application to quality control and manufacturing processes, change qualifications, verification and validation activities
Molecular biology and/or analytical chemistry laboratory skills and experience giving the ability to learn test assays with little guidance
Ability to author and revise GMP compliant documentation, work instructions
Efficient experimental design and execution
Analysis of large data sets
Effective use of project management tools
Strong presentation skills and appropriate adjustment for various business and technical audiences
Flexible: able to respond quickly to shifting priorities and meet deadlines
Strong expertise in data manipulation and analysis of large data sets using excel, and statistical analysis software such as JMP, minitab, etc.. Programming skills in R, python and perl a plus to support bioinformatics analysis and automated trending for statistical process control
Authoring and optimizing automation protocols for liquid handling robots such as Hamilton preferred
BS/MS in Bioengineering, Biology/Molecular Biology, biochemistry, chemistry, or related discipline
Three to eight years of industry experience with functional analysis QC or method development of molecular-biology-based assays preferred. Quality engineering, process engineering, R&D or manufacturing experience also desired
Proficiency with Microsoft Office tools (Excel, Word, and PowerPoint) essential
GMP experience in an FDA regulated environment is essential, quality training or certifications (CQE, CQA, Regulatory Affairs, etc.) preferred
Six Sigma and/or Lean certification and experience preferred
Experience with DNA or RNA sample preparation, next-generation sequencing, qPCR, capillary electrophoresis, enzymatic assay and/or Illumina technology is strongly preferred
Experience with analytical assays and equipment such as UPLC, ICS, LCMS, liquid handling robots, etc. preferred

Senior Qc Analyst Resume Examples & Samples

Participate in developing and validating analytical and functional testing methodology, revising and updating Standard Operating Procedures and supporting documentation
Author technical reports and change assessments for complex functional and analytical workflows as well as manufacturing and vendor change qualifications
Develop and validate of automated spreadsheets for data analysis
Lab execution of experiments
Technical support of production testing including OOS (out of specification) and NC investigations, root cause analysis and CAPA activities
Three to eight years of industry experience with functional analysis QC or method development of molecular-biology-based assays preferred. Other QC, process engineering, R&D or manufacturing experience will be considered
Experience with writing automation protocols for liquid handling robots such as Hamilton a plus
Molecular biology laboratory skills such as multichannel pipetting, PCR, etc. required
Ability to author and revise work instructions and perform molecular biology assays with little guidance
GMP and FDA experience
Six Sigma and/or Lean certification and experience
Experience with DNA or RNA sample preparation, next-generation sequencing, qPCR, capillary electrophoresis and/or Illumina technology
Experience with analytical assays and equipment such as UPLC, ICS, LCMS, liquid handling robots, etc
Understanding of medical device quality system requirements (21 CFR 820, ISO 13485, etc.) and appropriate application to quality control and manufacturing process change qualification, verification and validation activities

QC Analyst Resume Examples & Samples

Minimum of 1 year of HPLC experience within a highly regulated laboratory environment (IMB/FDA)
Recognized 3rd level science qualification (preferably chemistry / pharmaceutical based)
Proven technical ability in laboratory systems
Ability to work flexible shift hours if required
Computer skills MS Word, Excel etc

QC Analyst Resume Examples & Samples

Maintains adequate supply and orderly laboratory consumables
Calibrates or verifies calibration of instruments/devices prior to use
Participation and on time completion of required training activities
Conducts testing on raw materials, in-process, product, stability, and/or research samples
Conducts thorough data review to ensure completeness and accuracy of records
Reviews test results to ensure compliance with standards; reports any quality anomalies
Conducts review and investigations with supervisor/management as required
Writes and revises control test procedures and SOPs as required
May interact with outside customers or functional peer groups
May be responsible for maintaining a specific project
May assist in validation and/or transfer of analytical procedures
May be involved in establishing the transfer of methodology from R&D
Requires BS/BA in Chemistry, Biochemistry or related scientific discipline, with a minimum of 2+ year’s relevant HPLC experience, preferably in a cGMP pharmaceutical environment
Will substitute relevant experience for education

Senior Qc Analyst Resume Examples & Samples

Coordinate activities relating to the qualification, calibration and maintenance of laboratory equipment and related systems
Coordinate the purchase, commissioning and introduction to service of new equipment
Establish and maintain Equipment History Files (EHF) for QC laboratory equipment
Be the contact point for instrumentation issues and provide training and troubleshooting support to the laboratory on new or existing instrumentation
Coordinate all services provided by vendors, ensuring vendors meet all site requirements
Schedule/plan/execute validation activities and preventive maintenance of laboratory equipment
Monitor and ensure 21CFR compliance of all laboratory equipment and associated systems
Monitor and ensure ongoing compliance of all laboratory equipment and associated systems
Prepare, review & approve laboratory documentation related to laboratory instrumentation and systems (e.g. SOPs, validation protocols etc.)
Provide support to laboratory investigations involving laboratory systems
Follow written procedures as they relate to laboratory instrumentation
Communicate inter-departmentally and with outside contacts to solve laboratory instrumentation issues
Revise standard operating procedures as needed
Work independently under general supervision and direction
Demonstrate an understanding of CGMP's and how it applies to laboratory instruments
Exercise sound judgment and decision making when problem solving
#LI-GZ

QC Analyst Resume Examples & Samples

Conducts analyses concerning chemistry of drug products, components and processes for purposes of product and process development, quality control, quantitative and qualitative analysis
Instrumentation includes those of a basic (i.e. pH meter, microscope, UV/Vis Spectrophotometer, FT-IR, viscometers, density meters) to a high level (i.e. GC and HPLC) of complexity and difficulty
Prepares test data for appropriate review
Documents the procedures and results obtained in laboratory notebooks according to established regulatory guidelines
Assists in calibration and maintenance activities of instruments used in analyses
This position may require the labeling, packaging or movement of hazardous (flammable, corrosive, toxic, etc.) waste within the facility. If so, this employee would be trained in these subjects as per applicable local, state and/or federal regulations

QC Analyst Resume Examples & Samples

Testing all current finished products using assigned techniques, methods and procedures to agreed timescales
Complete testing data in accordance with Company Policy and legislative compliance to agreed time scales
Carry out peer checking of analytical test documentation as required
Report all OOS and Atypical data and results to the QC Supervisor
Participate in laboratory investigations as required,
To prepare and maintain all chemicals and solutions according to current procedures
Be conversant with the hazardous properties of chemicals and observe the safety rules
Assist in the management of laboratory stock items
Maintenance and calibration of instruments
To give assistance in maintaining and updating laboratory procedures, reports, logbooks, certificates of analysis and other documentation
To participate in training programmes
To assist in GMP and safety audits of the laboratory and other areas as required
Third level degree in science discipline
Minimum 2-3 years laboratory experience with good hands-on knowledge of common laboratory techniques and instruments including HPLC, GC, Dissolution, KF, LOD, Raw material testing experience is preferred
Software - Empower / Velquest / LIMS

QC Analyst Resume Examples & Samples

Carrying out testing duties, to supply quality product to the customer on time and in full in order to meet the objectives of the department
Testing of raw materials and finished products using the correct procedures in order to comply with GLP/GMP/H&S/SOP's and Environmental and regulatory requirements
Complete all QC batch documentation right first time (i.e. correct and in full) in order to achieve Customer Service and GMP
3RD Level qualification in a Science related discipline
Experience in HPLC is essential
2 years' experience in a similar laboratory is essential
Analytical Techniques
Operation of lab instruments
Documentation completion

QC Analyst Resume Examples & Samples

The position of QC analyst requires a third-level qualification (Minimum: Primary degree in a science discipline)
A minimum of 1 years experience within a regulated Environment, pharmaceutical advantageous
Knowledgeable of FDA/EMEA regulatory requirements applicable to pharmaceuticals and aseptic products

QC Analyst Resume Examples & Samples

BS degree in Chemistry from an accredited college or university or equivalent experience
Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc
Good knowledge of cGMPs and laboratory practices
Familiar with basic laboratory instruments
Excellent observation skills and problem solving abilities
Ability to follow analytical procedures and protocols
Good laboratory techniques
Ability to work in a methodical and organized fashion

QC Analyst Resume Examples & Samples

Minimum of 3 to 5 years direct work experience in AML risk analysis or equivalent with related experience in other areas of banking and preferably in the financial services industry
Excellent organizational, verbal, written, and interpersonal skills are required
Must be able to multi-task, adapt well to changing priorities, and effectively prioritize workflow to meet critical deadlines
Strong working knowledge of AML/BSA laws and regulations relative to money laundering and terrorist financing and the ability to apply this knowledge in assessing transaction activity; knowledge of monitoring of high risk customer accounts is preferred
The ability and willingness to work independently is required
Typically requires a Bachelor’s Degree, and CAMS certification is preferred
Must attend and complete Bank-sponsored job related training

QC Analyst Resume Examples & Samples

Perform and record analyses as assigned on a daily basis
Assist in maintaining a clean, safe workplace on a daily basis
Review and revise test methods
Write and disseminate technical data summaries and reports as needed
Research and recommend purchase of capital equipment as needed
Purchase laboratory supplies as needed
Coordinate sending samples and receiving data from contract laboratories as needed
Train other colleagues in methods and procedures
Ability to perform routine analysis, such as wet chemistry and operate basic laboratory equipment
Understands paperwork review process
Ability to follow written procedures and exhibit excellent documentation practices
Working knowledge of analytical techniques in wet chemistry and chromatography (HPLC, KF, pH, GC)
Practical experience with various types of laboratory instrumentation
Bachelors Degree in Chemistry with over 0-2 years of laboratory experience in a regulated environment

QC Analyst Resume Examples & Samples

Use of Laboratory computer systems
Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
Solid ability to interpret data
Prioritization and problem solving
Displays commitment to quality and performs job functions to the best of his/her ability

QC Analyst, Level Resume Examples & Samples

Reviewing assays
Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods
Bachelor or Associates Degree. Preferred area of study in Microbiology, Biochemistry or Related Science field
2-4+ years industry experience, preferably in a cGMP environment
Strong ability to interpret data
Perform assigned, complex and/or varied tasks with guidance from Supervisor
Comprehend and follow instructions
Brainstorming
Able to communicate in both written and verbal format
Completes assignments on-time and accurately
Timeliness in completing assigned tasks

QC Analyst Resume Examples & Samples

Supports Aseptic Process Simulations (APS‘) by performing environmental monitoring (EM), screening and counting fill-samples, and completing APS related documentation
Supports cleaning validations by performing environmental monitoring (EM), and completing related documentation
Performs routine EM, plate enumeration, utilities (pharmaceutical water, clean steam, gasses) sampling
Performs assays such as bioburden
Performs data entry via paper and electronic systems
May perform Gram stain and microbial identifications
General lab support including housekeeping, equipment maintenance, inventory of supplies, etc
Basic problem solving of methods as well as troubleshooting of equipment
BS/BA Science Or equivalent experience
0-2 Years of lab experience in GMP biotech or medically related field or HS Diploma with 3-4 years experience in a related GMP/GLP environment
Computer software skills including Microsoft Office and SAP, organization skills, record keeping, multiple projects, time management, aseptic technique
Knowledge of basic and specialized lab equipment
Knowledge of/ability to learn microbiological methods, microbial identification systems and use of lab equipment
Written and oral communication, team oriented, independent work skills, strong work ethic
Ability to gown aseptically
Ability to manage a robust work schedule and to function in a fast paced, changing environment
Ability to read, understand and follow SOP’s
Ability to understand importance of compliance with cGMP’s

QC Analyst Resume Examples & Samples

Perform testing in accordance with written procedures for: stability samples, raw materials and packaging components, in-process manufactured material, and finished product (bulk or packaged). (80%)
Write SOP’s defining calibration and preventative maintenance procedures
Execute and document preventative maintenance and calibration procedures on laboratory equipment
Compile data packages for submission to QC management for final review
Sample login verification
Perform new equipment demonstrations and evaluation
Data Security
Designated department training coordinator with responsibility for assisting manager with monitoring and tracking department training requirements. Responsibilities will include updating training requirements profiles; circulating and tracking training records; generating gap analysis reports; coordinating department training; and attending department training coordinator update/training sessions. (if applicable)
Minimum BS degree in Chemistry or related scientific field
Approximately 5 years’ laboratory experience in a regulated environment

Senior Qc Analyst Resume Examples & Samples

Conduct stability meeting and generate meeting minutes
Generate/present data summaries, trending, presentations, and reports
Participate and provide input to product or project stability plan to ensure compliance to SOP
Database optimization and automation for stability data storage and analysis for ease of data evaluation
Revise and update SOP and product testing procedures/worksheet as appropriate to correct and/or optimize testing processes
Assist in stability validation activities
Train entry level QC analyst - Review Stability Batch Records
Analyze and investigate stability products testing failures
Interact and obtain expertise from external departments to aid in investigation activities
Initiate and conduct meeting with external department expertise to resolve stability failure
Assist in Reference/Control Materials activities and finished product testing as needed
Perform other duties as assigned or requested
Working knowledge of PCR and microbiology laboratory experiences is highly preferred
Knowledge of analytical chemistry techniques and protocols is a plus
Knowledge of SQL database
IVD experience is preferred

QC Analyst Resume Examples & Samples

Specific understanding of the raw material (Drug substance, excipients and other non-chemical raw materials)/finished product sampling and testing procedures
Proficient in compendia testing procedures related to raw materials
Proficient in HPLC, GC, KF, ATR, DSC and specialized other wet analytical techniques e.g. ROI, heavy metals etc
Proficient in LIMS, trackwise, empower and lean laboratory operations
Proficient in Individual Container id testing, e.g. handheld Raman, NIR etc
Proficient in FDA, ICH, USP guidelines, cGMP regulations and laboratory safety procedures
Proficient in laboratory instruments/qualification program as necessary
Ability to react quickly to changes in project priorities and timelines
Approximately 8 years’ experience in pharmaceutical quality control laboratory

QC Analyst Resume Examples & Samples

To maintain a high standard of GMP / GLP in the Laboratory
To write and update SOPs and Protocols and review laboratory data as required
To review and check own work results for accuracy and presentation

QC Analyst Resume Examples & Samples

A Bachelor's degree (B.S.) in Chemistry or other Life Sciences field is preferred; will consider a candidate with an equivalent combination of experience and education
3+ years of related experience and/or training; or equivalent combination of education and experience
Excellent communication skills, both written and oral, as the employee will be expected to communicate directly with QC management, manufacturing supervisors, project managers, and clients, as applicable
Outstanding interpersonal skills and ability to foster/thrive in a team environment
Ability to multi-task and manage various projects: must be able to use individual discretion in the completion of work assignments while assisting the group collective to meet project deadlines and objectives
Proven ability to exercise judgment and appropriate escalation of issues to QC management is a must
Clear understanding of Good Laboratory Practices (GLPs), Good Documentation Practices (GDP), cGMPs, and other regulatory requirements
Demonstrated knowledge of analytical equipment and instrumentation utilized for the testing of APIs, associated drug product, and raw materials. Basic wet chemistry (e.g. pH, Karl Fischer), HPLC and UV Spectrophotometry experience working in GMP environment is required.. Additional experience with GC, UHPLC, IR and GC-MS will differentiate candidates
Ability to read, analyze and interpret scientific or technical procedures/literature and government regulations
Proficiency in basic computer software and hardware applications (e.g. Microsoft Word, Excel, Access) and application of mathematical operations to tasks (e.g. data trending and projections, outlier testing, etc.)

QC Analyst Resume Examples & Samples

Ensures compliance with cGMP's, Environmental, Health & Safety regulations
Executes all Quality Control activities to ensure timely & compliant launch of finished products
Executes all routine Quality Control testing to ensure timely & compliant release of finished products
Executes the finished product Exception Program
Supports regulatory requirements of finished products
Supports the timely receipt and release of finished products
Prepares and executes method development, validation plans and protocols for the laboratory
Supports the document control system & record retention
Ensures laboratory equipment is calibrated & properly maintained at all times
Executes and supports batch record reviews to ensure timely release of finished product according to schedule
Develops and implements Standard Operating Procedures
Promotes the maintenance of a safe, accident free and healthy work environment
BSc in a scientific discipline; minimum of two (2) years in a cGMP facility in a Quality Control role. Experience in HPLC (High Performance Liquid Chromatography) is desirable
Ability to read and understand the English language for the purpose of following instructions
Good knowledge of Quality Assurance, cGMP and GLP
Experience in using HPLC in a GMP environment

QC Analyst Level Resume Examples & Samples

Analysis of environmental, raw materials, in-process and final bulk product samples for microbial attributes according to Standard Operating Procedures and Test Methods. Primary testing includes bioburden, endotoxin, and total organic carbon analysis
Problem solving of analytical methods as well as troubleshooting of equipment
Perform all testing with minimal supervisor input
Develop new methods, optimize existing methods, and participate in method transfers/qualifications
Author deviations and investigations with supervisor input
Provide guidance to lower level analysts
Review routine and final product testing data
Experience with sterility testing and working in cleanroom environments is required
5-8 Years of lab experience in biotech or medically related field
Experience with sterility testing and clean room work is required

Temporary QC Analyst Resume Examples & Samples

Training others
Strong ability to speak publicly
Direct, control and plan tasks/projects
Exercises judgment within defined procedures and practices to determine appropriate action
Relate to others in a team setting
Works entire assigned shift, including arriving on time
2nd Shift position, either Sunday-Wednesday or Wednesday-Saturday

QC Analyst Level Resume Examples & Samples

SDS-Page
Capillary electrophoresis
ICE280
Appearance, pH, osmolality, PCR

QC Analyst Resume Examples & Samples

Perform and document incoming, in-process, and final QC testing of in-vitro diagnostics devices to meet compliancy requirements including ISO, FDA and international regulations
Labeling of pallets or container with QC accepted or QC rejected label as SOP required
Document QC test results on RMS or Pre-Assembly and Finished Product QC Testing Form, retain retention samples as needed
Familiarity with all aspects of product and be able to identify defects
Review, revise or generate procedures related to quality control
Work with suppliers regarding non-conforming parts/product and vendor corrective actions
Use Agile to issue Quality Incident (QI) reports; perform root cause investigation and write investigation report
Perform validation study or other appropriate analyses for new product or new features of the product. Create/document validation report
Prepare adulteration controls and DOA controls as needed
Be able to use analytical balance, optical comparator, vacuum chamber, caliper, gauges and the other tools to perform the raw material QC testing or measurements
Ensure timely release of product
Ensure cleanliness of the QC lab
May be required to work overtime (may include weekends) as defined by the needs of the department
Work effectively and independently. Cooperatively work with others in all matter of the organization
Be able to prioritize and handle multiple tasks and responsibilities, attention to detail
Good English written and verbal communication skills. Basic computer proficiency. Be able to use Agile to initiate QI and write investigation reports. Use Citrix and Sage 100 to enter raw material data
Moderate computer skill and moderate knowledge of MS Excel and MS Word
Be able to lift approximately 50 lbs
Assist the head of QC department with any necessary tasks and other duties as assigned

QC Analyst Resume Examples & Samples

Perform all lab functions in compliance with cGMP
Follow written procedures for the following tests, as trained and qualified
A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products
Ability to follow written procedures with close attention to detail
Ability to function with minimal supervision for routine job duties

QC Analyst, Chemistry Resume Examples & Samples

Perform testing for in-process, drug product and drug substance release and stability samples, including HPLC applications, gel electrophoresis, and capillary electrophoresis
Represent QC Chemistry on cross-departmental project teams and provide technical expertise as required
Perform assay trending analyses
Support laboratory investigations and help to develop investigation strategies
Review routine laboratory data for cGMP compliance
Support of QA systems including deviation, CAPA and change control
Train lower level analysts on assays and assist with mentoring and development of QC Chemistry staff
Write and review SOPs, test methods and reports
Support qualification of laboratory instrumentation
Support manufacturing as needed through stat testing, support of cleaning validations, hold studies, etc
Recognize aberrant test and sample conditions; investigate and troubleshoot technical issues; recommend appropriate corrective and preventive actions
Maintain knowledge of current scientific principles and theories. Train and mentor other lab personnel in areas of expertise
Support lab personnel as needed to meet lab operating needs
Perform all job functions in compliance with cGMPs and maintain accurate and legible laboratory records
Ensure training is current for all job functions
Review laboratory data and documentation as qualified and assigned
Subject matter expert in Analytical Chemistry testing and instrumentation
Able to author scientifically sound procedures and reports
Understand analytical and compendial procedures and be able to contribute to investigations and troubleshooting
Able to interact with multiple departments to collaborate and problem solve
Detail oriented and well-organized
Able to present scientific data and represent QC Chemistry in various forums including regulatory inspections
Good understanding of cGMP and its application in a laboratory environment
Strong organization skills and ability to manage multiple projects and timelines

GWM Latam Verification & QC Analyst Resume Examples & Samples

Performing quality review of new and existing KYC profiles for Latam Private Bank clients
Participate in project meetings and develop relationships with various teams within the Private Bank
Engaging in discussions with Risk, Anti Money Laundering, Onboarding Officers and Compliance partners, and documenting changes to workflow processes
Identify areas of risk that need improvement, and resolve using available tools (Excel, SharePoint, etc.)
Working with business, Risk, Anti Money Laundering, and Compliance teams to complete agreed upon business initiatives
Respond to daily inquiries and assist with escalation/resolution
Spanish and/or Portuguese fluency, both oral and written, required
Ability to communicate with all levels within the Line of Business

QC Analyst Resume Examples & Samples

Perform hands-on laboratory testing activities related to INC material and product release testing
Perform data entry and analysis to support product testing according to established methods, while measuring results against specifications
Author and update product testing procedures and worksheets, as needed
Support studies for internal customers, which include validation and change control activities
Author laboratory investigations and product non-conformance reports
BS in Biochemistry, Molecular Cell Biology or similar field with exposure to PCR and real time PCR principles
3 to 5 years of hands-on laboratory and/or manufacturing testing experience in a GMP environment
Minimum of 1 year of QC testing experience and demonstrated working knowledge of scientific principles in the in-vitro diagnostic (IVD), medical device and/or pharmaceutical industry
Effective problem solving, troubleshooting and analytical skills
Effective documentation skills
Excellent computer skills; especially proficient in Excel and Word
Be willing to work in a complex and fast paced environment, be a team player with effective communication skills, and have GMP documentation skills
Working knowledge of quality and lab processes, methods and techniques
Experience handling biological and chemical materials (PCR reagents, buffers, etc.)
Knowledge of cGMP's and regulations applicable to the FDA and international regulatory agencies
Working knowledge of real time PCR
Knowledge of analytical chemistry techniques and protocols
Knowledge of quality and manufacturing processes, methods, and techniques
Working Knowledge of GMP, ISO, and QSR regulations

QC Analyst Level Resume Examples & Samples

0-2+ years industry experience, preferably in a cGMP environment
Solid ability to speak publicly
Solid ability to communicate in both written and verbal format

QC Analyst Resume Examples & Samples

Inbound quality check
In-line quality check
Microbiological checks
Stability testing
Analyses: (HS)-GC, IR , HPLC
Analytical activities
Inspection in the factory, visual checks on materials, chemical analysis and trouble shooting
Writing quality reports according to quality regulations
Working according to ISO22716:2007
Minimum MLO - chemistry (level 3 or 4)
Perfect knowledge of Dutch
Able to work independently as well as a team member
Precise work attitude
Experience with working in an ISO or GMP environment is preferred
Flexible (working hours between 6:00 a.m. and 6:00 p.m.)

QC Analyst, Hour Rotating Night Shift Resume Examples & Samples

Collect and process samples in a timely manner, review laboratory7 assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties
Perform Water, Steam, and Critical Utility collection as well as associated testing
Perform Biological Indicator Testing
Perform Environmental Monitoring
Perform Endotoxin Testing (Gel Clot and Kinetic Turbidimetric)
Perform Bioburden Testing of In-Process products, buffers, and water
Receive manufacturing samples into the QC Lab as well as sample retain disposal
Enter and review data in LIMS
Perform general maintenance of lab equipment
Participate in writing and revisions SOPs, protocols
Assist in the development and optimization of testing methods
Ensure labs are clean and safe (in compliance with cGMP) and properly stocked
Make detailed observations in support of Alert, Action, and OOS result investigations
Participate in the qualification of equipment, methods, and processes
Participate and perform special studies & projects assigned to microbiology
Perform plate reading, streaking, gram staining, microbial identification
Perform routine Quality Control testing of in-pro0cess and final products in a cGMP lab for release
Perform other additional job related duties as required
Key responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
1 year experience in a cGMP lab environment
Working knowledge of Aseptic practices and technique
Proficient in Outlook and MS Work and Excel and lab based data management systems

QC Analyst Resume Examples & Samples

Perform UV-Vis spectrophotometry,HPLC and Gel assays for in-process and final product samples
Review of QC Data for compliance to procedures and specifications
Participate in training of less experienced staff
Transfer methods from support groups to the QC laboratory
Author protocols and technical reports related to the implementation of QC equipment
Effectively demonstrate an understanding of cGMPs and application to specific responsibilities
Follow accurate written procedures for testing of in-process and final product samples
Communicate inter-departmentally and with outside contacts to solve technical issues
Work in compliance with cGMPs
Practice safe work habits and adhere to Genzyme's safety procedures and guidelines
Master's Degree in Life Sciences discipline and 1year experience in cGMP lab environment
Experience with Empower software
Knowledge of lab-based data management systems

QC Analyst Resume Examples & Samples

Perform UV-Vis spectrophotometry, HPLC and Gel assays for in-process and final product samples
Investigate and troubleshoot Quality Control methods
Prepare investigations related to OOS/OOT results
Prepare statistical analysis of results
Participate in training of less experienced staff on new procedures
Provide technical leadership and guidance for the successful completion of major laboratory projects
Implement new quality control procedures
Transfer and develop new methods
Implement and monitor personnel training
Work effectively with others to achieve shared goals
Work independently with minimal supervision

Senior Qc Analyst Resume Examples & Samples

Perform maintenance on complex laboratory equipment including HPLC and GC systems
Prepare investigations related to 005/00T results
Review QC Data for compliance to procedures and specifications
Develop and author complex and explicit documentation for new and current procedures and technical reports
Identify deviations from QC methods
Recommend method improvements
Interact with external personnel on technical matters requiring coordination between sites
Work independently with minimal supervision and direction
Bachelor's Degree in Life Sciences discipline and 4 years experience in cGMP lab environment, or
Master's Degree in Life Sciences discipline and 2 year experience in cGMP lab environment
Proficient in Outlook and Microsoft Word and Excel and lab based data management systems
HPLC (high pressure liquid chromatography) experience
Familiarity with USP and global compendia requirements

QC Analyst Resume Examples & Samples

Compare actions taken and processes implemented with written procedures to ensure consistency
Keep up to date knowledge of changes in laws, policies, regulations, and guidelines
Conduct daily, weekly, monthly, and quarterly audits to ensure policies/procedures are followed properly and in accordance with regulations
Develop reporting to accurately reflect any findings and/or recommended changes to department processes
Understanding of Collections and Third Party Vendor Management
Work hand in hand with management team to better processes and reduce risk/exposure
Various other functions as required
Minimum of Bachelor's Degree or equivalent experience in lieu required
4+ years of experience in collections or default
2+ years of training or similar experience

QC Analyst Level Resume Examples & Samples

2-4+ years industry experience, preferably in a cGMP environment Use of Microsoft Suites (Word, Excel, Powerpoint)
Use of Laboratory computer systems Potential previous use of GMP Quality Systems such as: TrackWise, LIMS
Perform assigned, complex and/or varied tasks with guidance from Supervisor. Prioritization and problem solving

QC Analyst Resume Examples & Samples

Routine wet chemistry testing of raw materials, in process, finished product and stability samples in strict compliance with GLP & cGMP procedures
Sampling of raw materials/excipients and water samples when required to assist the QC Sampling Technician
Support validation programmes including process and method validations
Minimum of a Bachelor's degree (or equivalent) in a Science related discipline (preferably Chemistry) and 0-2 years of relevant industrial experience
Strong analytical skills with excellent attention to detail
Communication skills both verbal & written with good time management skills

QC Analyst Resume Examples & Samples

Execute activities, as assigned, for the optimization, validation, transfer, and life cycle management of test methods used for release testing of raw materials
Conduct tasks for laboratory equipment qualification and re-qualification program
Review compendial updates and initiate workflows for corresponding revision of test methods
Coordinate logistics and communication with contract testing laboratories for supplier certification testing
Review data generated by contract laboratories (internal and external labs)
Provide proficiency training to QCRM staff with respect to analytical methods principle and critical parameters
Support ongoing readiness for regulatory inspections and compliance audits
Practice safe work habits and adhere to Genzyme’s safety procedures and guidelines
Maintain proficiency training per assigned curricula
Key Responsibilities may differ among employees with the same job title and may change over time, in accordance with business needs
Associate’s degree in related discipline
5 years’ experience in cGMP laboratory environment
Previous experience with Microsoft Outlook, Word and Excel
Previous experience with lab based data management systems
Ability to lift 40 lbs
Bachelor’s Degree in Life Sciences discipline and minimum of 2 years’ experience in cGMP laboratory environment
Experience with validation of analytical methods
Experience with inspections/audits by FDA and other regulatory agencies
Technical background and familiarity with laboratory control operations and quality systems
Scientific technical writing ability

QC Analyst Resume Examples & Samples

Collect and process samples in a timely manner, review laboratory assay documentation for accuracy and timeliness, evaluate preliminary results; aids in the development of test methods and participate with the team to meet group goals and perform routine laboratory duties
Perform Water, Steam and Critical Utility collection as well as associated testing
Perform Endotoxin Testing (Gel-Clot and Kinetic Turbidimetric)
Perform Bioburden Testing of In-process products, buffers, and water
Receipt of manufacturing samples into the QC lab as well as sample retain disposal
Troubleshoot assay and instrument problems with Laboratory Supervisor
Perform safety and operational lab audit
General maintenance of Lab equipment
Participate in writing and revising SOPs, protocols
Maintain log books related to inventory and equipment
Ensure labs are clean and safe (in compliance with CGMP) and properly stocked
Make detailed observations in support of Alert, Action and OOS result investigations
Perform ELISA testing
Provide training and technical leadership to less experienced staff
Participate in authoring complex and explicit documentation (Protocols and technical reports)
Involvement in equipment or facility qualifications (IQ, OQ, and PQs) and method validation
Perform plate reading, streaking, gram staining, and microbial identification
Perform routine Quality Control testing of in-process and final products in a CGMP lab for release
1 Year Experience in a cGMP lab environment

QC Analyst Resume Examples & Samples

Microbiology testing of bulk, raw materials and finish product. Data entry and occasional review of data
Participate in non-routine projects to meet departmental and individual goals
Provides input to and aids in the development and revision of SOPs laboratory operations
Write or review investigation reports and other forms required by the investigation procedure
Critical thinker, ability to identify issues and work quickly to resolution
Capable of managing/coordinating multiple priorities in a dynamic environment, while maintaining a professional demeanor
Understand common microbiological test instrumentation and method development/validation
Excellent organizational, planning and scheduling skills
Experience of Thermo Sample Manager LIMS or other LIMS systems
BS in science, concentration in Biology/Microbiology
Minimum 3 years’ experience in a GMP pharmaceutical manufacturing facility
Experience with the execution and validation of microbiological tests methods for sterile and non-sterile drugs, their raw materials, components and in-process testing
Experience with methods described in USP Chapters 61, 62, 71, 85, 788 and relevant informational chapters

QC Analyst Resume Examples & Samples

Analytical testing of in process, release and stability of drug substance and drug product
Testing includes but not limited to HPLC, CE, RT-PCR, A280, ELISA and wet chemistry methods
Perform testing in accordance with Standard Test Method procedures
Keep accurate and complete records per cGMP
Document deviations, assist in determining root cause and apply CAPA
Support the execution of approved protocols for the validation of analytical instruments and test methods
Write and revise SOPs and worksheets, instrument SOPs, and other documentation as needed
General laboratory support, including but not limited to, sample receipt, inventory control, reagent preparation and equipment and instrument maintenance
Assist in transfer of assays to internal groups or external organizations, as needed
Experience with cell culture and bioassay a plus
Requires minimum of Bachelor's degree in a scientific discipline or equivalent
Minimum 3-5 years of experience in a QC GMP laboratory environment
Knowledge of cGMP and ICH
Possess a strong work ethic along with solid time management and interpersonal skills
Demonstrated experience analyzing critical data and proactively solving problems. Individual must be flexible, work well in a team environment and possess developed organizational skills
Experience with Agilent HPLC, PA800 CE, Molecular Devices and Applied Biosystems instruments a plus

QC Analyst, Intermediate Resume Examples & Samples

Bachelors Degree in a biological field
2 years experience in a Clinical or Quality Control or research laboratory
GMP/QSR/ISO background/ASCP certified Histotechnician or Clinical Laboratory Scientist is desired
Experience with Immunohistochemistry, InSitu Hybridization or Special Stains is preferred
Technical writing skills are required
Candidates should be well organized, detail oriented, have refined technical writing ability

QC Analyst Resume Examples & Samples

Chemistry or Food Technology degree
Knowledge on quality and food safety system
Deciding & initiating action
Delivering results & meeting cutomer expectations
Applying expertise & technology
Analize thinking
Creating & innovating
1 - 2 Years of experiences in the same field

QC Analyst Resume Examples & Samples

Current experience processing Conventional purchase and refi loans
Understanding of all compliance regulations and investor guidelines
Ability to accurately calculate income for all income types
Proficient with paperless mortgage loan origination systems
Basic understanding of mortgage quality control and compliance
Ability to work overtime as required by the department manager based on the work requirements
5+ years of current Processing experience
Conventional Mortgage experience required
Desktop Underwriter and Loan Prospector experience required
VA experience preferred but not required
Mortgage Quality Control and Compliance background a plus

QC Analyst, Level Resume Examples & Samples

Running test samples for In-Process, Lot Release and Stability studies Reviewing assays Training others Writing- Quality Records (Deviations, CAPA, Change Control) and Test Methods Projects – such as method transfers, new instruments, method qualifications
Bachelor or Associates Degree. Preferred area of study in Microbiology, Biochemistry or Related Science Fields
3-5+ years industry experience, preferably in a cGMP environment
Excellent ability to interpret data
Perform assigned, complex and/or varied tasks. Make basic quality decisions independently
Comprehend and follow instructions. Be able to communicate instructions to others in a clear, concise manner
Act as an example of professionalism to other Level 1 and 2 analysts
Works entire assigned shift, including arriving and departure on time

Loan QC Analyst Resume Examples & Samples

Review and maintain loans and participations uploaded to Fiserv Signature ensuring the integrity and accuracy of the loan
Verify that the codes and information are accurate dependent on Heartland loan policy and federal regulations
Responsible for reviewing Change in Term agreements processed in Fiserv Signature; work with Loan Maintenance to correct errors when identified
Quality control the maintenance performed in Fiserv Signature based on request for change submitted by the Member Banks and processed by Loan Maintenance
Provide quality control of non accrual, charge off, ORE and risk rating changes submitted via the Risk Maintenance RFC
Perform daily reconciliation of automated upload, manual bookings and Fiserv Signature New Loan report. This is a key audit control
Receive and follow through on projects assigned efficiently accurately and on the projected deadlines
Cross train with each Loan Operations area and provide back up where necessary
Knowledge of Windows operating system and of Microsoft Excel, Word, and Outlook
Knowledge of Bank Core Systems
Familiarity with bank loan policies, processes and procedures
Knowledge of Federal Regulations
Ability to work effectively in a fast-paced environment
Critical and creative problem solving
Experience with troubleshooting and/or research loan issues
Performed loan maintenances activities

QC Analyst Resume Examples & Samples

To perform Microbiology testing of In-Process / Finished Product samples, Raw materials and environmental monitoring/water samples in accordance with written procedures and best practice
Accurate and timely recording of all information pertinent to the task being performed in LIMS and the relevant Laboratory Notebooks
To plan and execute all work in an accurate, efficient and timely manner
To maintain proper records and generate reports in line with operational and regulatory requirements
Initiate, Compile and Complete laboratory investigations using Root Cause Analysis
To ensure that all aspects of GMP / GLP are maintained to a high standard
To write and update SOPs and Protocols when required
To perform a quality/technical review of data generated in the Laboratory
To ensure a high standard of Safety and Housekeeping is maintained in the Laboratory
To provide training, technical support to other personnel in the department and in other departments
To ensure all instruments and equipment are maintained in a calibrated and operational state
To represent the organisation/department as may be required due to technical knowledge and ability

QC Analyst Resume Examples & Samples

Perform efficient/reliable/high quality analytical testing in accordance with USP/NF/EP/JP/FCC/etc. or customer supplied guidelines. Typical testing may include Dissolution, Titration, Polarimetry, Loss on Drying, Viscosity, Residue on Ignition, Heavy Metal Content, FTIR, HPLC, and GC, etc
Maintain accurate written records of all analysis performed
Accurately interpret and effectively communicate analytical results and issues
Schedule daily tasks in an organized and efficient manner
General knowledge of the use and operation of basic laboratory equipment
Calibrate and maintain lab equipment and instrumentation
Responsible for operating in a safe manner, must be familiar with basic laboratory and chemical hygiene practices
Become proficient in standard operating procedures and test methods
Ability to work in a “flow to the work” team environment
In combination with other lab personnel, be responsible for a clean and safe work environment
Perform peer review of analytical testing and write up
Write SOPs on an as needed basis
Bachelors Degree in Chemistry, Biology, Chemical Engineering or Life Sciences (Preferred in Chemistry or Biology)
0 to 5 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role (including internships or co-op experience)
Ability to multi-task with high efficiency
Ability to work well under pressure and maintain efficiency
Basic knowledge of lab safety and the ability to work safely with chemicals of varying potency
General computer literacy including use of Microsoft Word and Excel
Ability to perform analytical testing while standing for long periods of time
Accurate testing on the first attempt under pressure of production details
Experience in the pharmaceutical industry preferred
Inspection of products, test results, and appropriately maintaining computerized documentation of required information

QC Analyst Resume Examples & Samples

Performs routine testing of samples submitted to the laboratory. Documents all test results in compliance with procedures and GDP requirements. Maintains compliance with SOPs, GLP, GMP, and HSE requirements. Maintains laboratory equipment in compliance with procedures and GLP requirements
Enters data into LIMS system. Assists with LIMS data entry to support LIMS maintenance and validation activities
Maintains personal training file. Responsible for training of other analysts as directed by management
Assists with scheduling of raw material, intermediates, environmental monitoring samples, and finished goods submitted to the laboratory as directed by management
Assists in the ordering and stocking of laboratory supplies; may have responsibility for inventory management
Provides input to laboratory investigations and documents invalid test results in compliance with procedures. Assists with nonconformance and CAPA investigations in compliance with procedures
Assists with revisions to standard operating procedures
B.S. with 2-6 years of relevant experience preferred; advanced degree in relevant field can be substituted for experience
Working knowledge of relevant biochemistry or microbiology laboratory techniques and GLP principles
Demonstrated use of software tools for data entry and analysis
Demonstrated ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility

Temporay QC Analyst Resume Examples & Samples

Participate in Laboratory investigations and Root Cause Analysis
To maintain/adhere a high standard of housekeeping, Dress Code and Safety within the Laboratory
To report to and be directed by the Laboratory Management

QC Analyst Resume Examples & Samples

Perform hands on laboratory testing of INC materials and finished goods as part of Quality Control
All data generated is produced from established methods and it is measured against established specifications
Participate in the initiation of laboratory investigations, data summary's and compile data for documentation of test results
Revise and update product testing procedures, work instructions, and worksheets, as appropriate
Help maintain the QC Laboratory, as required
REQUIRED KNOWLEDGE, SKILLS AND ABILITIES (MINIMAL COMPETENCIES)
Bachelors degree in Biochemistry, Molecular Cell Biology or similar field
0 to 2 years of related work experience
Quality Control/Manufacturing testing experience
Experience working in a GMP compliance environment and working knowledge of FDA/ISO requirements
Strong team player with excellent interpersonal and communication skills
Strong multi-tasking skills and attention to detail
Experience in handling biological and chemical materials
Able to work independently and interface effectively with multiple disciplines within different functional groups

Lead-qc Analyst Resume Examples & Samples

This is a 3rd shift position*
Complies with all pertinent regulatory agency requirements
Maintains laboratory supplies
Support additional projects as needed
Provides on-the-floor guidance and support to employees
Ensures employees timesheets are completed on time
Monitors employees training to ensure that all requirements are met, including OJT
Maintain up to date training records for self and direct reports
Perform minimally monthly performance feedback meetings with direct reports
Escalates all performance issues to management and/or HR
BS/BA in Life Sciences or related field preferred; will substitute relevant experience for education

QC Analyst Resume Examples & Samples

To assist in the scheduling of work over a 3 to 6 month time span
Plans and organises own and other team members workload over 1 week period
Establish and implement short term priorities
Day to day planning of own work and completes tasks to deadlines as agreed with Laboratory Supervisor
Short horizon planning for OOS investigations
To ensure that EHS policies and procedures are adhered to and reviewed as required
Willing to be involved in working with a team as well as independently
Has a keen eye for detail
Is literate, numerate and computer literate
Has good planning and organising skills with ability for problem solving
Is able to communicate effectively with colleagues and managers within laboratory

QC Analyst Resume Examples & Samples

Minimum 1 year analytical experience in a similar environment
Possesses a thorough understanding and experience of laboratory procedures and laboratory skills, the practices, principles, and theory of chromatography, and other disciplines such as chemical analysis, laboratory instrumentation, etc
Experience with chromatography and analytical instrumentation
Experience of using analytical data packages, for example Empower
Working knowledge of computer packages (Word, Excel, Outlook, etc)
Experience and knowledge of Pharmaceutical/Medical Devices/GMP environment
Experience of working in a team environment
Ability to prioritise and manage multiple tasks effectively
Ability to convey information clearly and accurately
Understanding of the relevant quality standards
Ability to see the bigger picture and understand impact across the organisation
Good analytical skills and ability to think logically in order to problem solve
3 years analytical experience in a similar environment
Identification and implementation of process efficiencies
Supporting an environment within the business of open, honest two way communication
Being clear both in written and spoken communication. To be swift in response and to ensure accuracy at all times with information
To be aware of the receiver of the information and adapt communication accordingly
Take ownership and responsibility for your PDP to ensure development opportunities are identified and achieved
Supporting effective communication within the business to facilitate the flow of information, building rapport and collaborative relationships with others
Demonstrated use of GSK Spirit beliefs and behaviours
There is a requirement to deal sensitively at all times with the multi cultural key stakeholders to the site. All stakeholders to be treated with respect and to be aware at all times that English may not be their first language
Receive into the Laboratory and test all materials and products in accordance with GMP regulations
Ensuring all records are reviewed, verified and approved by a second analyst, carrying out corrections where relevant
QC disposition on LIMS and Movex (BCA role only)
Performing basic troubleshooting and maintenance on instrumentation as required
Assisting with training and mentoring of other analysts
Identifying and progressing updates in documentation, including lsops, training documentation, methods, etc
Carry out L1 audits
Assisting in the technology transfer of new products and packs by providing analytical support, review of appropriate documentation, equipment evaluations, etc
Providing analytical support in various forms such as stability analysis, method development, out of specification investigations etc
Executing experiments as required supporting method validation, cleaning validation, regulatory requests and stability etc as required
Supporting the validating and transferring new equipment and new technologies into the laboratory and manufacturing as required
Preparing samples as requested by GSK sites and Stiefel customers
Calibrating all relevant instrumentation according to the relevant procedures
Support customer complaints ensuring investigations are performed and completed

QC Analyst Resume Examples & Samples

Experienced on working to GMP
To work with the line manager or designated analyst to test and interpret results as required
To be familiar with chemical and biochemical methods, test specifications and sampling regimes, and the impact they may have on the product
To maintain detailed laboratory records in accordance with current Good Manufacturing Practice (cGMP) through the use of controlled pro forma or laboratory notebooks
To ensure that all records and test results are accurately prepared and checked, peer reviewed prior to submission for approval for authorisation and according to company, customer and regulatory requirements
Record deviations from the normal practice and out of specification results appropriately and report them to the line manager; assist with investigations product and test anomalies
To ensure compliance with established procedures and Departmental Safety Codes of Practice
To deliver and assess formal training programmes for staff and trainees as required
Ensure that the department is kept in a safe, clean and orderly fashion and maintained in an inspection ready state
Responsible for the condition and maintenance of the laboratory equipment, ensuring records are maintained of any calibration, maintenance
To facilitate the ordering of laboratory consumables to ensure efficient running of the laboratory
To be responsible for the safe storage and/or disposal of test samples, reference materials and reagents following set procedures. To record incoming samples according to the appropriate SOPs. To ensure all samples and materials are handled safely following departmental procedures
Write, review and update SOPs and associated pro-forma used within the laboratory, prepare draft method of analysis and SOPs when new techniques are introduced in the area
To participate in the validation of test methods and equipment used in analysis to meet regulatory requirements

100

QC Analyst Resume Examples & Samples

To independently perform analysis of samples submitted from both internal and external manufacturing sites for which the job holder has been trained
To test samples utilising a range of chemical, biochemical and biological tests, in accordance with regulatory requirements and agreed schedules
To apply a knowledge of Physico-chemistry testing to the provision of product testing and stability data
To work with the line manager or designated analyst to interpret tests results as required
Work in a safe manner and in compliance with Safety Codes of Practice and policies
To use Root Cause Analysis, and other OE tools
Plans and organises own workload over 1 week period
To ensure that GMP and EHS policies and procedures are adhered to and reviewed as required

101

QC Analyst Resume Examples & Samples

Develop and maintain working knowledge of commonly used spectroscopic and chromatographic procedures
Process samples with the standard procedures effectively and under minimal supervision. Analyze experimental data for validity before reporting results
Keep contemporary, accurate, legible, and complete experimental records in accordance with GMP and GLP practices
Submit complete, documented, and legible reports of analytical testing. Ensure that data is properly filed and accessible for review in accordance with appropriate SOP’s
Recommend and implement methods to increase the quality of products and/or services
Manage workload and time to enable the incumbent to perform multiple projects effectively, and ensure all necessary paperwork is completed on a timely basis
Participate in self-development activities and training of others
Associates, Bachelor’s or Master’s Degree with major in Natural Science or Pharmacy, or equivalent industrial experience

102

QC Analyst Resume Examples & Samples

Develop and maintain working knowledge of commonly used spectroscopic and chromatographic procedures. Establish a demonstrated expertise in at least one technique
Write analytical method procedures to establish format
Write analytical validation reports
Establish new and improved ways to perform job by challenging established procedures

103

QC Analyst Resume Examples & Samples

Understands the data review process
Knowledge with Empower, LIMS, ELN, SDMS etc
Ability to cope with a rapidly changing work environment
Good interpersonal skills and ability to work effectively in a team environment
Commitment to continuous improvement in all areas
Ability to work safely; seek out and encourage safe practices
The successful candidate will be responsible for managing their time, organizing their workload to be efficient, and have good organizational and communication skills
Direct interaction with internal and external auditors
Ability to take on additional tasks, as required
Bachelors Degree in Chemistry with over 2 years of laboratory experience in a regulated environment

104

QC Analyst Resume Examples & Samples

Troubleshoot problems encountered with existing analytical methodology and instrumentation. Identify OOS results, atypical results, and atypical laboratory events requiring a laboratory investigation. Perform investigative testing and write investigation reports
Strong working knowledge of analytical techniques, such as wet chemistry and chromatography as well as analytical instrumentation operation, troubleshooting and maintenence
Understands and independently navigates the data review process
Bachelor’s Degree in Chemistry with 5 years of laboratory experience in a regulated environment

105

Senior QC Analyst / QC Specialist Resume Examples & Samples

The incumbent will perform analytical testing of biologic drug substances, drug products and other materials according to approved methodologies using HPLC, CE and other techniques
Responsible for following all appropriate SOPs, methods, policies and safety guidelines and training of other QC analysts as requested
Prepare reagents, samples, and equipment according to SOP’s and maintains the instrumentation and lab facilities
Will be responsible for completing and reviewing laboratory documentation in a cGMP compliant manner
Expected to work on special projects and other duties as assigned

106

QC Analyst, / Ii-temporary Resume Examples & Samples

Assist in write-up and review of Worksheet Validation Protocols
Assist in completing deviations related to the Worksheet Validation
Maintain organized records and comply with GMP documentation practices
Assist in completing reports related to Worksheet Validation
1 year of relevant hands-on pharmaceutical laboratory experience
Demonstrated computer proficiency, e.g., word processing, spreadsheets, graphing, etc.. Proficiency in MS Excel is preferred
Ability to write in a concise, logical fashion
Ability to manage multiple responsibilities with a high degree of self motivation
Good oral, written, and interpersonal English communication skills
Ability to effectively utilize scientific information resources within the assigned area of responsibility

107

QC Analyst Resume Examples & Samples

Analysis of environmental samples according to Standard Operating Procedures and Test Methods
Routine environmental monitoring of air, surface, water, gas and steam systems
Complete GMP and Safety Training
Problem solving of test methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next
Perform general lab support
Perform assay review when achieve assay competency with supervisor direction
Initiation, review and closure of Deviations, CAPA’s and/or Change Controls
Perform document changes

108

QC Analyst, Intermediate Resume Examples & Samples

Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers and management
Manages contract laboratories
Conducts analysis associated with clinical and non-clinical laboratory studies under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and Organization for Economic Co-Operations and Development (OECD) as well as International regulations
Performs analysis on raw materials, in-process materials, APIs (developmental and commercial), final product and other requested testing as per written procedures
Reviews data for compliance to specifications, and reports and troubleshoots abnormalities

109

QC Analyst Resume Examples & Samples

Perform Environmental Monitoring in an aseptic environment (batch, routine, and gowning monitoring)
Perform utilities monitoring (WFI, CLST, PW, RO, CAIR, NIT) and testing
Endotoxin
Nitrates
TOC
Conductivity
Enumerate organisms on cultured media
Review paperwork
Perform general lab tasks-autoclave, hood cleans, dry heat oven, lab cleans
Work in laminar flow hoods
Gowning in an aseptic environment
Maintain documentation in accordance with GMP including timely recording of information
Pays attention to detail and ensures high quality work
Self-starter that takes initiative to perform work with minimal supervision
Maintains a clean, organized lab environment
Commitment to teamwork
Willingness to learn new things
Effective communication with co-workers and supervisors
Ability to work hard and contribute to an enjoyable working environment

110

QC Analyst, / II Resume Examples & Samples

Language Skills: Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization
Mathematical Skills: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry
Reasoning Ability: Ability to apply common sense understanding to carry out instructions furnished in written, oral, or diagram form. Ability to deal with problems involving several concrete variables in standardized situations
Computer Skills: Microsoft Outlook, Explorer, Excel, Word, PowerPoint

111

Senior Qc Analyst Resume Examples & Samples

Performs broad spectrum of routine tasks in their functional area
Reviews documented information from their functional area, reports abnormalities
Prepares and executes protocols (including IOQ/PQ as applicable), authors technical reports, as needed. Interacts, and coordinates with Regulatory, QA and other departments for protocol approval/amendments
Acts as Lead investigator for Level 2 Non-Conformance and OOS and alert investigations. Prepares investigation plan and summary reports
Prepares documentation for presentation to Regulatory Agencies
Applies critical thinking to solving problems of complex scope
Works on complex problems where analysis of situations or data requires an in-depth evaluation
Acts independently to develop procedures on new assignments. Assists the implementation of new technology
Assists supervisor by assembling QC metrics as requested for their functional area
Provides direction and training to analysts
Owns QIMS records in Trackwise and DCRs in Aegis
Performs biennial review of and approves process SOPs
Represents Supervisor at meetings, etc as requested and performs selected Supervisor duties as requested
Represents QC on site committees such as EHS, etc

112

Credit Risk QC Analyst Resume Examples & Samples

Establish working relationships with management
Maintains a comprehensive working knowledge of Originations and/or Servicing policy/standards and procedures
Assists with the creation and implementation of group’s procedures and process maps
Maintain a quality control program in compliance with company objectives
Review and testing of first line of defense controls environment including QA programs to ensure proper controls exist to identify and control risk
Review individual contracts for adherence to policies/procedures and related funding process
Transform conceptual ideas or concepts and create real-time solutions
Build, code and develop large data sets which support the evaluation of the 2nd line QA programs and processes
Examine servicing actions for adherence to policies and procedures, including but not limited to extensions and modifications
Reports results of quality control testing to management and other applicable individuals
Responsible for the monthly reporting of all findings and deficiencies identified through process monitoring
Continually evaluate and enhance process workflows to implement best practices
Develops and maintains a detailed understanding of all processes and applications related to assigned business area
Assess the impact of changes to business area systems and processes; provides recommendations and/or feedback on identified risks to current process, workflows or applications
Assist with requests from Internal and External Auditors and Regulators where applicable to demonstrate compliance with control and regulatory requirements
Performs other duties as assigned

113

Programming QC Analyst Resume Examples & Samples

Bachelors in Computer Science or MIS or 7 years’ equivalent experience
COBOL programming experience
JCL experience - building and updating
Proven success creating, executing, and updating test plans and test scripts

114

QC Analyst Resume Examples & Samples

Responsibility to follow safety and housekeeping standards
Responsibility to perform a number of routine laboratory operations, such as
Test chemical samples using spectrophotometry, refractive index, Karl Fischer titrations, gas chromatography, liquid chromatography, gravimetric analysis equipment and other analytical techniques
Prepare samples using chemical treatment and distillations
Perform process and product quality control tests using above method
Communicate test results to production personnel
Responsibility to perform instrument calibrations as scheduled
Responsibility to follow procedures as written and to alert QA/QC management of any deviations to procedures
Responsibility to use Laboratory Information Management System (LIMS) to collect, organize, and report QC test data
Responsibility to interpret data from standard procedures
Promote, participate in, and support Six Sigma and HOS cultures
Support Kaizen teams as requested
Authority to prevent the use of non-conforming raw materials, in-process samples, and finished product
Authority to prevent the use of non-conforming equipment and standards
Assist on special projects and miscellaneous job tasks as assigned
Coordinate priorities with Shift Leaders to improve productivity
Maintain safe housekeeping
Ensure that all waste generated in respective areas is managed according to regulations
Must follow SOPs for using RCRA hazardous waste accumulation areas including waste compatibilities, inventorying, and container management (closing container & labeling)
Clean-up of small spills
Complete Waste Accumulation Areas Inspections
Over site of HSE compliance within department
A minimum of a two-year science related degree
1 year of experience working in an industrial setting
Four-year science related degree (Chemistry, Chemical Engineering, Physics, Biology) is preferred
Proficiency in LIMS & DAS
Effective verbal and communication skills
Team Player and excellent interpersonal skills
Computer proficiency in WORD, ACCESS, Q-pulse & EXCEL

115

QC Analyst Resume Examples & Samples

Work Experience – 0 to 5 Years in a Quality, Laboratory, Clinical or Chemical Manufacturing role (including internships or co-op experience)
Knowledge/Skills Requirements: (List unique knowledge skills, or problem-solving requirements)
Laboratory Procedures
Safely perform testing required by position
Knowledge of and proper use of equipment
Safely handling chemicals and compounds
Regular cleaning of lab space as required
Coordination with other laboratory associates for maintaining safe environment
Assisting with other personnel with lifting of liquid containers and all objects of greater than 50 lbs
Maintaining clean environment for laboratory operations
Use of and safe handling of glass canisters, chemicals, and other required equipment
Coordination in a laboratory setting
Operating safely in a dynamic environment which includes mobile and fixed equipment and changing conditions while completing job tasks that range from simple to complex and/or multi-tasking

116

QC Analyst Resume Examples & Samples

Perform routine analysis on complex laboratory equipment including HPLC and GC systems
Recommend laboratory and equipment-related improvements
Work effectively with others to achieve shared goals and meet timelines
Interact with internal and external personnel on technical matters requiring
Bachelor’s degree in Life Sciences discipline and 1 -3 years of experience in CGMP lab environment, or Master’s degree in Life Sciences discipline and 0- 2 years’ experience in CGMP lab Environment
Experience in Microsoft Office; Empower data system and lab based data management systems
Ability to present technical data
Familiarity with USP and global compendia regulations
Scientific technical writing ability including authoring and revising SOPs, validation protocols and technical reports
Experience troubleshooting of assay and equipment issues

117

BSA / AML QC Analyst Resume Examples & Samples

Conduct quality control audits on department functions, including model validation on the AML transaction monitoring system, customer risk scoring analysis (including transaction thresholds), OFAC screening, risk assessments, rule effectiveness and daily validation from core/Bankway to Prime
Evaluate TPPP due diligence process for on-going monitoring
Evaluate CIP and CDD processes for compliance to bank’s procedures and handling outstanding exceptions; update policies and procedures on customer identification and due diligence
Conduct sample testing on new account documentation including business documents (scanned on Fortis)
Evaluate on –going performance enhancements for model validation and implement recommendations received from consultants, audits/examiners
Conduct an annual review with Credit Review department regarding ACH originators, identify any AML investigation cases
Evaluate processes on the AML monitoring system’s configuration settings and threshold’s. Retain supporting documentation of the rationale for all rule configuration and AML system settings and the process of determining appropriate rule parameter rationale and parameters selected
Conduct ongoing monitoring and evaluation of rule performance with procedures for responding to any problems that appear. This evaluation should be reviewed by the BSA Officer
Review the system’s “audit log” that contains changes in alert rule configurations on a periodic basis to verify that there have not been unauthorized changes to alert parameters and configurations made
Evaluate the department’s “Prime Change Management Policy folder” on approved application changes, rule modifications and operator access right changes, etc
Evaluate OFAC processes regarding on-going screenings (new customers, periodic full customer, beneficiaries of standby letters of credit, TPPP merchants)
Conduct sample testing on CTR transactions to ensure all cash transactions (specifically armored car services) are captured in the aggregation report and to ensure preparation of CTRs includes accurate information and mirrors guidance
Must have knowledge of all federal requirements under the Bank Secrecy Act requirements including Customer Identification Program/USA Patriot Act and OFAC (Office of Foreign Assets Control)
Must have BSA/AML experience with a regulatory compliance department, risk management or consultant position handling BSA/AML audits; preferred experience in a financial institution with asset size $10B and over
Must be able to work in a regulatory compliance department and interact with internal and external auditors/examiners
Must be a participant of a BSA/AML Certification program and current certification (or in process)
Prefer to have previous banking experience and knowledge of branch operations
Computer skills (Word, Excel, Access)
Excellent organizational skills and communication skills; the ability to interact well with others and possess a team player attitude
Punctuality & attendance is a must; strong telephone skills

118

QC Analyst Resume Examples & Samples

Trending and review of results in timely manner ensuring the raw material KPIs are met
Perform QC analytical testing as required
Perform accurate technical review/authorisation of test data including trending and technical review of data
Train and mentor new analysts as required
Bring new technology into department and lead / manage associated projects
Ensure a high level of housekeeping and safety
Lead Root Cause Analysis process and write up within department or across cross functional groups for complex issues, identify the solution and implement
Efficient scheduling of analysts work using lean lab concepts in the absence of the Supervisor or as required

119

QC Analyst Resume Examples & Samples

Maintain direct material finite scheduling tool and generate team performance metrics
Schedule testing to QC Analysts
Generate and communicate demand forecasts to contract lab partners
Escalate direct material risks to management
Monitor test, review and release adherence to planning/SAP due dates
Coordinate with internal customers and suppliers to ensure timely delivery of samples in support of multi-site operation activities and expedited testing
Complete COA and initial identity testing and assess against established criteria
Evaluate data to identify trends and/or establish limits
Identify discrepancies. Provide input to design of quality investigations and CAPA (corrective actions preventive actions) initiatives as needed
Identify gaps in systems and procedures
Receive and provide training
Assure and apply GMP throughout operations
Support internal and external audits and regulatory inspections
Works to meet standard lead times
Participate in and/or lead group and project teamwork; project and process improvements
Meets scheduled performance of 95% on time
Perform other duties as requested by managers to support Quality activities

120

Temporary QC Analyst Resume Examples & Samples

Conduct laboratory operations in a safe manner. Maintain familiarity with the Chemical Hygiene Plan. Exhibit safety awareness and safe work practices
Follow responsible actions regarding chemical disposal. Maintain compliance with all regulations at the federal, state, and local levels, as well as appropriate SOP’s
Use sound judgment and previously acquired knowledge and experience to develop new procedures for new compounds
Process samples with the standard procedures effectively and independently. Analyze experimental data for validity before reporting results
Use and maintain equipment in a neat and orderly manner. Report any malfunction immediately to supervisor. Repair minor problems. Maintain service and calibration records
Use technical and regulatory knowledge and judgment to validate procedures to comply with internal SOPs and regulatory needs with minimal supervision
Discuss routinely with supervisor the status of assigned programs and potential problems
Organize work time so that multiple activities run concurrently. Use time efficiently to accomplish immediate task and perform other needed activities
Volunteer to assist with other tasks in the analytical function not directly related to specific projects
Participate in self-development activities. Provide orientation and train new personnel on operating procedures and policies
Perform other related duties as may be reasonably assigned in the course of business
Chemical Hygiene training
Other pertinent training/courses

121

QC Analyst, Protein Characterization Resume Examples & Samples

Perform analytical testing to support the release, stability, and in process testing of raw materials, samples, or final products and supports the release of materials for production or products for commercial use
Accurately follow relevant SOPs, perform all activities in accordance with the cGMP requirements and report abnormalities
Initiate and complete laboratory discrepancy events on time
Legibly document test results to ensure completeness and accuracy per cGMPs
Keep accurate documentation and track records
Compile, enter and review data into LIMS or other databases/Excel sheets
Evaluate data/interprets trends and write Quality Control technical reports
Demonstrate knowledge of operating, maintenance and troubleshooting skills for analytical instruments to include HPLC as well as quality and regulatory requirements pertinent to quality control labs
Perform laboratory cleaning activities
Contribute towards the development, revision, application, maintenance, validation and review of quality systems, drafting SOPs, and methods for processing and/or ensuring quality in raw materials, intermediates, or finished products
Perform Discrepancy Management investigations
Assist with the drafting of laboratory investigation reports
Support department improvement projects related to release goals, the identification of root cause for investigations, and the improvement of laboratory test methods
Support the implementation of corrective and preventative actions
Perform assay training, manage multiple tasks concurrently and effectively
Perform non-routine laboratory tasks
Address questions during regulatory compliance audits and support inspection-related needs as required
Bachelor’s Degree in science or technical field
Four (4) to five (5) years of experience performing relevant activities including working in a cGMP compliant environment
Experience with protein, carbohydrate, small molecule and excipient testing of Chromatography techniques
Experience with chromatography systems and software (Waters/Empower, Dionex/Chromelean, Agilent/Chemstation, AKTA/Unicorn)
Ability to multi-task and good adaptability to changing business requirements in a dynamic corporate environment
Strong computer and communication skills
Experience with equipment and analytical method validation laboratory execution
Strong technical writing skills for reports and SOPs
Experience with Wet-Chemical techniques, Elisa assays, Gel Electrophoresis Capillary Electrophoresis, Spectroscopy
Familiarity with Bayer products and manufacturing processes

122

QC Analyst Resume Examples & Samples

Conduct routine and non-routine analysis of raw materials, in process and finished formulations according to SOP’s
May be involved in activities regarding development of ELISA methods for use in QC lab and may perform assay transfers, qualification and validation of new methods in the QC lab
Compile data summaries, data trending or spread sheets and prepares corresponding reports
Strong expertise in assay execution and method validations of ELISA’s
Requirements for QC Analyst (ELISA)
BS Degree in Chemistry, Bio-Chemistry or related scientific field
Minimum of 1 year QC experience
Experience/knowledge on ELISA method validations and assay execution
Experience authoring SOP's, protocols and technical reports

123

QC Analyst Resume Examples & Samples

To perform assigned quality control testing
To operate and maintain QC laboratory equipment and instrumentation
To sample chemicals to obtain a representative sample
To transfer bulk containers to saleable and quarantine locations
To maintain high levels of housekeeping within work area
To support the QC Team Leader with general administration work
The job holder is to play an active role in the Company’s commitment to quality and efficiency in QC operations
To support other member of QA & QC group to achieve timelines set
Liaising with the QC Team Leader and other departments to ensure that analysis is carried out on time and in line with customer expectations
To comply with the requirements of the EMS and act appropriately with regard to issues affecting impacts on the environment. Assist in achieving environmental objectives and targets
To comply & conform with the environmental and quality policy, procedures and with the requirements of the EMS & QMS and act appropriately with regard to issues affecting impacts on the environment and conforming to product requirements. Assist in achieving environmental and quality objectives and targets
To operate any equipment and conduct your day to duties according to current procedures and appropriate Health and Safety precautions
Participate in Continuous Improvement and Lean Manufacturing activities on site
To carry out any other duties within the employee’s skills and abilities whenever reasonably instructed

124

QC Analyst Resume Examples & Samples

Perform a wide variety of bioanalytical to support in-process and bulk drug substance release
Complete own test records on time and peer reviews data from other analysts for accuracy and completeness
Assist in the design and set-up of the QC laboratory and selection/ implementation and calibration of laboratory instruments
Perform cell based potency assays and immunoassays such as ELISA
Subculture mammalian cell lines and perform cell counts
Perform virology assays using PCR techniques
Participate in the transfer of methodology from other test facilities
Provide support and advice to manufacturing on QC related topics
Maintain laboratory reagents and supplies
Write new and updates current SOPs as needed
Provide training to other analysts in the QC group
Present bioanalytical data reports clearly and concisely to management
Proactively identify and implement lab process improvements, lean initiatives
Perform any other duties relevant to the QC laboratory position as required

125

QC Analyst Resume Examples & Samples

Perform required testing in accordance with CSL/Compendial methods for the analysis of finished product, raw material or in-process testing
Maintains accurate, complete, legible and concurrent records of work performed and enters results in the laboratory notebook
Demonstrates the ability and willingness to follow schedules and met deadlines
Rapidly gains awareness of cGMP and maintains compliance with these regulations
Interacts within the department
Other duties as assigned by Laboratory Management

126

QC Analyst Resume Examples & Samples

To perform laboratory development, validation and testing procedures in accordance with the relevant protocols, study plans and standard operating procedures (SOPs)
Assist the managers in scheduling the department workload, ensuring the laboratory areas are adequately resourced, and that all work is performed in compliance with Good Laboratory Practice (GLP) and Good Manufacturing Practice (GMP)
To perform laboratory work and data analysis in a timely manner and to a high standard
Provide regular updates to the Study Director(s)/Department Managers regarding the status of ongoing projects and studies, including any deviations, non-conformances and out of specifications immediately
To assist the Study Director/Scientist in any investigation and/or corrective and preventative actions (CAPAs) processes as required
Ensure that all department laboratories are in compliance with the relevant cleaning, housekeeping and general procedural SOPs
Provide technical laboratory support for Study Directors/Scientist in conducting investigations and troubleshooting
Ensure that all work is performed in accordance with relevant health and safety procedures and that all risk assessments relevant to the work being performed (COSHH, GMO etc) are read and understood prior to undertaking work
Perform all relevant Quality Control duties in accordance with the requirements of GMP
SGS Vitrology personnel shall have sufficient authority to delegate tasks without discharging their responsibility
Perform all duties and tasks in accordance with relevant GLP and GMP guidelines
Perform all duties in accordance with SGS Vitrology Health and Safety requirements and Quality Policy
At all times, adopt a safe behaviour by exercising due regard for the health and safety of yourself, colleagues and clients, in line with the Company’s policies and procedures
Ensure full compliance with the Company’s Code of Integrity & Professional Conduct, and at all times adopt behaviour in accordance with SGS UK’s Equality and Diversity Policy

127

QC Analyst Resume Examples & Samples

Perform equipment calibrations, PM’s, troubleshooting and qualifications and complete required documentation on a daily basis
Work with equipment vendors to coordinate onsite visits for any work needed
Attend any meetings as required
Practical troubleshooting experience of various types of laboratory instrumentation is required
Ability to operate and calibrate laboratory equipment is required

128

QC Analyst Resume Examples & Samples

The routine chemical and physical testing of raw materials used in or arising from the Company's production operations, in accordance with agreed schedules
Particular focus on finished product testing, but will be expected to support the team in other activities as required
To report any out of specification or out of trend results to a supervisor and to document any deviation from written analytical procedures. To liaise with production supervisors to schedule and report in-process analysis
To carry out stability testing of samples in accordance with the relevant procedures and cGMP
Ensuring that all testing is carried out within the expected time scale by setting priorities when required
Reporting and recording analytical results utilising authorised Quality Documentation systems, in compliance with cGMP
Assisting in maintaining a clean working environment within the Quality Control Laboratory
Writing stability reports in accordance to cGMP and liaising with customers
Ability to develop and maintain good working relationships with colleagues
Testing of raw materials
To assist in the investigation of out of specification or out of trend results for QS
To operate documented systems to ensure that duties are performed to and maintain GMP standards
To perform duties in a safe and efficient manner
To perform and document other general laboratory duties as directed by a supervisor

129

QC Analyst Resume Examples & Samples

Perform analytical testing in an accurate, timely and efficient manner, consistent with cGMP requirements. Testing may include, but is not limited to, routine particle size analysis, cleaning verification, identification testing (FTIR), method development and validation (including particle size and cleanability assessments), DSC, Surface Area Analysis, method optimisation and trouble-shooting, technology transfer and pharmacopoeia analyses as appropriate
Keep up to date with industry/regulatory developments in relation to particle size technology and cleaning verification/validation techniques
Ensure documentation is accurate, legible and presented clearly and concisely, consistent with cGMP requirements
Document all activities associated with cGMP compliance. These include, but are not limited to, instrument calibration and maintenance, out of specification (OOS) investigations and deviation reports
Prepare test methods for particle size analysis and cleaning verification analysis
Prepare Standard Operating Procedures (SOP’s), including corporate and departmental guidelines
Prepare analytical test reports for submissions to clients or the Company’s other departments. These include, but are not limited to, Statement of Results, Certificate of Analysis and Cleaning Certificates
Communicate with the QC Laboratory Manager, Operations, QA, client representatives, service providers and equipment vendors as appropriate
Maintain accurate and up-to-date training records. Attend training seminars and sessions related to any of the above mentioned topics
Review SOP’s, raw data, investigations and any analytical test reports as appropriate
Maintain cleanliness of laboratory and workspace
Order routine chemicals and consumables as appropriate
Work within current EHS guidelines and provide input into EHS improvements within the QC laboratory and elsewhere on site

130

QC Analyst Resume Examples & Samples

Biological Indicator Testing
Perform Sterility Testing
Perform Growth Promotion Testing
Perform Plate Reading
Conduct data analysis based on sample specification
Participate in writing and revising SOPs
Performs other additional job related duties as required
Performing routine QC testing of in-process and final products in a CGMP lab for release
ELISA testing, container closure testing, particulate testing, HACH, and plate streaking
Involvement in equipment qualification (IQ, OQ, and PQs) and method validation

131

QC Analyst Iv-raw Materials Resume Examples & Samples

Leads the project for assessing new and current raw materials to determine appropriate identity testing requirements per applicable quality guidelines, setup and establishment of identified test methods, and revision of relevant documentation. Attains pre-determined milestones, and communicates interim results to management
Communicates with subcontract labs to obtain information regarding capabilities, test timelines, and costs for testing unable to be performed in-house. Prepares sample shipments and submission paperwork for contract laboratory testing. Reviews data received from contract lab for cGMP compliance
Performs routine and specialized raw material testing, including IR/Raman spectroscopy, wet chemistry analysis, and may also perform investigational testing or special experiments as instructed
Performs hemoglobin, total protein, immunoelectrophoresis (IEP), radial immunodiffusion (RID), and bacteriophage testing of sera products
Performs water sampling and conducts testing for total organic carbon (TOC), conductivity, nitrates, chlorine, hardness, and pH
Preparation and scheduling of all testing to ensure timely initiation and release. Communicating and collaborating with QC supervisors and analysts concerning raw material workload and schedules to ensure timelines are met
Provides QC laboratory support on an as needed basis (to include, but not limited to sample receipt and stability activities)
Performs general lab support activities such as housekeeping, equipment maintenance, inventory/ordering of supplies. Writes/revises Standard Operating Procedures and provides suggestions for method improvements. Serves as QC representative on project teams. May lead QC projects. Provides advanced level training in addition to basic and specialized activities. Writes OOS/Deviation investigations and assists with technical investigations

132

QC Analyst Resume Examples & Samples

Responsible for assisting with laboratory analysis for commercial release and routine stability testing
May conduct routine release and stability analyses of developmental and commercial compounds, prototype formulations and finished products in support of clinical testing for IND and NDA submissions
Perform laboratory analysis under guidance of a supervisor or designee
Conduct testing independently and may assist other analysts in analytical testing including flow cytometry, automated cell counting, ELISA, PCR, and other analytical laboratory testing
Conducts routine analytical experiments using analytical methods and procedures
Draws basic conclusions from data and results and communicates with other analysts and management
Performs instrument/method troubleshooting within analytical method parameters and management guidance
Performs testing for development and commercial samples, release and stability samples in accordance with established methods, specifications and protocols with limited supervision
Documents/reviews laboratory work using laboratory notebooks/worksheets that is detailed, timely and in compliance with GLP/cGMP requirements

133

QC Analyst Resume Examples & Samples

To carry out analytical testing on Raw Materials and Finished Products in compliance with GMP requirements
To provide technical support as required by management
Sample and check all incoming goods
Analyse Raw Materials, In-Process Materials and Finished Products
To maintain all laboratory notebooks, records, chromatograms to an acceptable GMP
To maintain good housekeeping and hygiene within the laboratory
To maintain and follow all relevant Standard Operating procedures
To calibrate and maintain all designated laboratory instruments
To support the laboratory testing schedule in order to achieve an efficient QC system
To bring to the notice of the supervisor or manager any discrepancies, deviations or non conformances in testing or work practice
To follow up-to-date analytical practices with reference to pharmacopoeias, specifications, regulations and industry standards
To adhere to any agreed rostered non-test tasks
To maintain the retain samples system if requested
To conduct analyst training as appropriate
Support the implementation of the Operational Excellence Programme on the site by identifying and implement improvements
Responsible for the handling and storage of Controlled Drugs in accordance with relevant procedures, ensuring product security
To ensure that cGMP standards are maintained at all times
To adhere to all company and legislative health, safety and environmental requirements
Any other duties as assigned by the QC Laboratory Manager
3rd level qualification in a science related discipline
At least 3 years industrial experience working in a cGLP/cGMP environment
Strong organisational skills / ability to prioritise work
Excellent troubleshooting and problem solving skills with good attention to detail
Ability to think logically and be proactive
Ability to work as part of a team and on own initiative in a constructive manner
Flexible and self motivated

134

QC Analyst Resume Examples & Samples

Analyze samples in support of: instrument qualification; method verification and validation; the raw material testing program; process validation; in-process testing requirements; R&D, stability testing; API testing and finished product testing
Prepare solvent mixture, buffers and reagents as needed for testing
Assist in the installation qualification (IQ), operation qualification (OQ) and performance qualification (PQ) of new laboratory equipment as needed
Write and review standard operating procedures (SOPs) for equipment operation, methods and general laboratory procedures as needed
Follow company SOPs and cGMP in the performance of all responsibilities
Perform method development and method validation for specified projects
Process and analyze microbial, bioanalytical and analytical data
Review microbial, bioanalytical and analytical data and test results and compare to test specifications. Prepare analytical lab reports
Experienced, with training, in current good manufacturing practices (cGMP) is preferred
Experience in FDA and USP testing requirements is a plus
Experience in stability testing programs is a plus
Ability to work as part of a team and also independently with minimum supervision
Able to handle, pick up and move laboratory materials, reagents and supplies
Ability to sample raw material in a warehouse setting
Good verbal and writing communication skills

135

QC Analyst Resume Examples & Samples

Performing complex analytical assays over a period of up to weeks to complete
Analyze results, identified trends and troubleshoot assays
Enter results in LIMS, SAP and other tracking databases per cGMP
Reports abnormalities and takes the appropriate action based on the method SOP and technical knowledge
Initiates Discrepancy events and performs investigations
Performs analytical equipment maintenance and laboratory cleaning activities per cGMP standards
Maintains lab to inspection ready status at all times
Assists with addressing questions during regulatory compliance audits and supports inspection-related needs as required
Partners with QA and Production to answer technical questions
Bachelor’s Degree in Chemistry, Biochemistry or related major
2-4 years’ experience working in a compliant lab environment, cGMP preferred
MS Excel and Word
Ability to work on teams

136

Senior Qc Analyst Resume Examples & Samples

Comfort with coordinating the activities with other staff members
Comfort with working in a team environment
Knowledge of cGMPs

137

Senior Qc Analyst Resume Examples & Samples

Perform routine and non-routine analytical biochemical and molecular biology assays to support release, characterization and stability testing of raw materials, production intermediates and final goods
Identify and drive the development and implementation of activities to improve Turn-around-time (TAT) and operational excellence
Setup, revising and updating Standard Operating Procedures, system or processes to improve compliance and execution
Constantly review procedures and processes and work closely with key internal partners to improve QC efficiency
Lead troubleshooting on discrepancy observed in laboratory or material as necessary
Ensure that the lab processes are compliant with Quality System and EHS requirements
Assignment may include but not limited to evaluation of NCR, OOS, OOT, training and drive improvement to QC KPI metrics
Work in accordance with procedures and ensure compliance to regulations and requirements in preparation for FDA and ISO third party audits
Works on problems of diverse scope where analysis of data requires review and interpretation of identifiable factors. Demonstrates solid judgment in selecting methods and techniques for obtaining solutions
Establishes working relationships across functions. Employs internal working relationships to influence business objectives
May provides leadership and mentor junior staff to resolve routine issues
Other such duties that may be determined by Management

138

QC Analyst Resume Examples & Samples

Performs routine testing of samples submitted to the laboratory. Documents all test results in compliance with procedures and GDP requirements
Maintains compliance with SOPs, GLP, GMP, and HSE requirements
Maintains personal training file
Maintains laboratory equipment in compliance with procedures and GLP requirements
Assists in the stocking of laboratory supplies
Theoretical knowledge of relevant biochemistry or microbiology laboratory techniques and GLP principles
Knowledge of software tools for data entry and analysis
Ability to read, understand, and execute standard operating procedures related to the assigned area of responsibility
Executes activities under supervision of Group Lead or Manager, with guidance provided by more senior analysts
Communicates results and issues to Group Lead or manager

139

Temp-qc Analyst Resume Examples & Samples

Performs laboratory cleaning activities
Coordinates laboratory sample requests and maintains sample inventory
Data entry, filing and other administrative duties
May perform certain basic and routine quality control testing after demonstrating proficiency, as needed
Participates in the overtime and weekend schedule as required
Requires a degree in Life Sciences or related field; will substitute relevant experience for education

140

Senior Qc Analyst Resume Examples & Samples

A minimum of 5 years’ work experience in a regulated GMP/GLP environment
Experience of leading other QC analysts and scheduling daily activities
Experience troubleshooting QC methods
Practical experience with wet chemistry methods
Experience with writing and reviewing SOP’s / validation protocols / reports
Experience with Method transfer / validation is essential
Experience working on cross functional teams
Excellent organisational, communication, interpersonal and report writing skills
Demonstrable experience motivating and leading a team of Analysts
LI-PD2-EUR

141

Image QC Analyst Resume Examples & Samples

Keeping a positive working relationship with Management, Product Stylist and Photographers, Image Retouchers, web editors and outside vendors
Expressing ideas and feedback clearly in both written and oral formats with cross-functional partners to maintain image quality
Focusing on maintaining image guidelines for consistency across a range of product photography in a high volume studio for all Fanatics branded sites
Partnering with a diverse team on workflow and file management, using internal software systems
Maintaining a digital asset file structures and organizational system
Performing assignments within the time frame given using your creativity and instincts
Matching images to data to confirm correctness
Managing over 200 products per day

142

Qp-qc Analyst Resume Examples & Samples

Complete calibrations of MT&E equipment
Complete calibrations of personnel tooling
Require attention to detail, ability to read, comprehend blueprints and adhere to technical manuals and procedures
Coordinate and work with supervision to support key events for tooling requirements
Must possess good oral and writing skills
Knowledge of MPRII, EWP & Lotus Notes
Knowledge of pressure gages used in testing
Knowledge of calibration of electrical tooling
Coordinate the purchase of new tooling that will require calibration
Familiarization with EBC special property control requirements
Conduct audits
Safety Performance
Interface with various customers on tooling issues
Review and understand SSP's, SP's and Company Policies and Procedures
5+ years of calibration experience or equivalent machine shop experience with precision tooling is required
The ability to read, interpret and work from blueprints, specifications and procedures is required
Candidate must have math and problem solving skills consisting of arithmetic, simple algebra, fractions, and decimals
High School/GED preferred; AS/BS in Engineering is preferred (any discipline)
Related commercial or Military/Navy precision tooling calibration experience is preferred
Experience in quality control is desired

143

QC Analyst Chemistry Resume Examples & Samples

Analysis, release and testing of samples
Documentation in compliance with GMP and GxP standards
Compliance with 6S standards
Support Laboratory Investigations
Knowledge of working practices required for a Chemistry / Biochemistry laboratory
Good knowledge of basic computer programs such as MS Word and Excel
Good understanding of quality principles and good attention to detail

144

Wealth Management Latam Verification & QC Analyst Resume Examples & Samples

Act as partner to the Banker teams to assist with the KYC renewals process for existing clients
Bachelors degree required; Major in Finance/Accounting preferred; 3-5 years’ experience in financial services focus on Latin America preferred
Portuguese fluency, both oral and written, required
Knowledge of Anti Money Laundering (various account inflows and outflows) is strongly preferred
Advanced Microsoft Excel skills, Word, PowerPoint, SharePoint, and Project skills
Team player and demonstrated work ethic

145

QC Analyst Resume Examples & Samples

Timely facilitation of incoming sample receipt and accessioning flow, decipher batch assignments across all assay types in accordance with agreed upon best practices
Execute microbiological and/or analytical methods to facilitate in-process testing under applicable cGMP guidelines, as well as contribute to the prompt reporting of results to meet the required timetables of internal customers
Evaluate completed assay validity, calculate and summarize results, analyze data per expected or specification ranges. Assist with the compilation and verification of trend analysis reports
Perform and collaborate with co-workers to appropriately share general housekeeping activity assignments, and ensure systems for laboratory maintenance are adequate for creating a consistent state of inspection readiness
Assist with monitoring and the control of laboratory supply and critical reagent inventories
Qualify as trainer for specified methods, provide training to less experienced staff
Provide on call coverage to support oversight of QC laboratory equipment functionality
Exhibit proactive communication upon occurrence of compliance risks and deviations from laboratory procedures, perform initiation of investigation records within required timeframes
Provide input or assay support to the progression of test method validation, investigations, technical studies, and method transfer protocols
Attend team huddles and department meetings, generate ideas for laboratory infrastructure improvements and method optimization
Perform other responsibilities as deemed necessary
0-3 years of relevant laboratory experience; QC specific experience is preferred
Experience with quality management systems, current Good Manufacturing Practices, and QC principles
Demonstrated working knowledge with respect to certified functional activities
Good documentation, written and verbal communication skills are essential
Must possess the ability to perform most tasks with minimal supervision
Must have a quality service attitude and focus, exhibit flexibility and willingness to work additional hours to meet production or laboratory process requirements

146

QC Analyst Resume Examples & Samples

Perform detailed data review for analytical test results generated by QC department for compliance with cGMP, internal SOPs and Specifications to support production, stability studies and lab operation. Review release and stability data, trend charts of reference standards, lab equipment calibration records and log-books and other review function as needed
Perform detailed data review for analytical test results generated by contract testing labs to assure their correctness and accuracy
Writes and revises control test procedures and SOPs
Completes test records and reviews data
Requires BS/BA in Life Sciences or related field, and a minimum of 2+ years’ relevant experience, preferably working in a cGMP pharmaceutical environment. May substitute relevant experience in lieu of educational requirement

147

BPO QC Analyst Resume Examples & Samples

Ensure accuracy of order information and any support documentation required to provide BPO provider
The Valuations Analyst I is responsible for ultimately delivering the most accurate and timely BPO report possible to SAM clients
Communicate results and challenges to management, internal customers, and team members
Monitor & research exception reports
Regular, consistent, and predictable attendance is an essential function of this job. Hour requirement will be 28 hours to be met over 5 consecutive days during the week. Hours are not guaranteed
Ability to meet deadlines with accurate and complete information
Ability to be a self starter, goal oriented, focused and precise

148

QC Analyst Resume Examples & Samples

Outstanding communication skills, both written and oral, and will be expected to communicate directly with project managers, coordinators and department managers
Conducts analysis associated cleaning validation under current Good Manufacturing Practices (GMP) regulations and guidance per Food and Drug Administration (FDA) and International regulations
Performs analysis on cleaning validation samples and supports cleaning validation projects
Reviews and reports data per specifications
Supports resolution of analytical testing anomalies
Ensures equipment is performing well and communicates and takes appropriate action as necessary
Required to follow good documentation practices
1 to 3 years of experience and/or training; or equivalent combination of education and experience
Proven knowledge of cGMP guidelines
Demonstrated knowledge of analytical equipment and instrumentation, microbiology experience working in a GMP environment is preferred
Knowledge of FDA regulations and guidelines
Proven skills in coordinating and managing day to day tasks and working in collaboration to accomplish deadlines and objectives
Personal leadership skills and fosters working in a team environment
Works cross functionally to complete projects and testing
Knowledge of and skills using computer software and hardware applications, including Microsoft Word and Excel

149

Senior Qc Analyst Resume Examples & Samples

Perform timely Post-Funding Quality loan reviews for mortgage originations and modifications activity to assess the accuracy and integrity of the information used to support the lending decision and adherence to federal and state compliance requirements, policy and procedures, GSE requirements, all related contractual terms and agreements
Participate in reviewing and maintaining all Post Fund Quality scripts, procedures, and methodologies
Work with business to ensure proper identification of cures
Learn other areas of responsibility within the Quality Team in order to perform call monitoring quality, and procedural adherence reviews for bulk transactions and servicing
Ensure consistent feedback to production management as it relates to quality and escalation to Senior Management when no corrective actions occur
Communicate and facilitate within the quality review team process, procedure and regulatory changes as necessary
Provide sufficient and timely reporting to management as required
Participate in the identify and monitor trends to provide consistent and actionable feedback to Senior Management on gaps in need of improvement in all aspects of quality reviews performed for the mortgage channel
Ability to collaborate with business units to ensure root-cause analysis is incorporated into the correction action process
Maintain a high degree of accuracy, departmental productivity and quality team goals
Maintain current knowledge of business policies, procedures, federal & state regulations, GSE and investor requirements
Works on special projects and other assignments as needed
Strong understanding of mortgage lending including operations and mortgage compliance
Working knowledge of conforming and non-conforming product guidelines, underwriting policies, loan documentation requirements and GSE Seller guidelines
Proficient with Microsoft Word, Excel, and Outlook
Demonstrated ability to learn computer systems and adapt to new programs
Dedicated and cooperative team player
Ability to problem-solve and exercise independent judgment while displaying a high degree of initiative; ability to work productively under minimal supervision
Good working knowledge of mortgage banking practices and systems, particularly quality control
Proven leadership in engaging cross-functional stakeholders while working with urgency
Excellent oral and written communication -- to internal and external customers
Demonstrate Ally Bank Core Values

150

QC Analyst Resume Examples & Samples

Communication (verbally and orally)
Prioritizing multiple projects and assignments
Following through to completion and meeting competing deadlines
Right-the-First-Time Attitude

151

QC Analyst Resume Examples & Samples

Carry out analysis of raw materials, intermediates, process controls and finished products
Perform analytical validations
Write SOPs for the management of analytical instrumentation
Monitor, according to internal procedures, to ensure that laboratory equipment are maintained
Perform stability studies

152

Senior Qc Analyst Resume Examples & Samples

Analyze automated adjustment reports; communicate irregular trends and provide direction to correct non-compliance issues
Oversee required training deadlines are met; completion of focused buyer analysis; first payment review analysis
Review exceptions for proper follow-up and to ensure appropriate underwriting guidelines are met; review and track verification summaries
Provides ongoing support to the sales group with regard to company underwriting policy
Compiles management trend reporting daily and monthly
HS diploma or equivalent required. Bachelor's degree in related field strongly preferred. 5 + years in customer service or financial services industry is needed. At least 2 years leadership experience preferred
Contribute to and manage projects

153

QC Analyst, Italy Resume Examples & Samples

Perform analyses according to official procedures and methodologies
Promptly report to the line manager or QA any departure from standard processes and procedures, including out of specification test results
Write and/or execute microbiological method qualification and validation according to contemporary quality standard (e.g. UPS, Ph. Eur, ICH, GMP) and internal procedures
Perform sampling for microbiological analysis of Active Pharmaceutical Ingredients, dosage forms, raw materials and environmental monitoring according to GMP and internal procedure
Actively participate in the development of sampling plans of Active Pharmaceutical Ingredients, dosage form, raw materials and environmental monitoring
Develop procedures and methodologies for microbiological lab equipment management and sample analysis according GMP and internal procedure
Actively participate in the investigation and root-cause identification of products and premises contaminations from microbiological perspective

154

Senior Operational Risk / QC Analyst Resume Examples & Samples

Manage a staff where the work is complex and diversified in nature. Responsible for the oversight of work assignments to ensure appropriate distribution within team
Review and analyze controls in place for each process; recommend opportunities for improvement to ensure improved compliance and mitigate risk, ensuring processes are completed thoroughly and per legal requirements and corporate policies. Follow up to validate effectiveness
For deficiencies found in our testing, identify those items with patterns or trends that occur over multiple periods that could lead to possible escalated actions by Operations
Participate in new Call Monitoring Scorecard development; ensuring the team and Operational Leadership is calibrated on all Scorecard Elements
Handle escalations and disputes from Operations
Perform detailed analysis and be able to use sound judgment
Develop test guidance to address risk within the various processes or create new testing for additional lines of business that would impact the CCG activities
Complete, review, and analyze the results of defined sampling and evaluation of various quality control processes. Communicate results to the appropriate management personnel. Assist management in identifying employees who would benefit from additional training one-on-one or in small groups, setting targets and service level agreements, and tracking improvement related opportunities for compliance and effectiveness
Handle escalated and complex problems and issues, investigating and eliminating problem situations
Serve as the site liaison responsible for testing required compliance & risk activities
At least 5 years financial services experience or compliance related experience required
Excellent verbal & written communication
Discretion & confidentiality
Strong facilitation and conflict resolution skills
Self-motivated and self-starter
Ability to lead and manage projects
Attention to detail and follow up critical
Proven ability to establish a collaborative environment
Be able to mentor existing staff members and new team members
Cross functional knowledge preferred; familiar with Customer Service, Fulfillment, Remarketing, Collections, Loss Mitigation processes, policies & procedures
Strong knowledge of state and federal regulations as they relate to Ally's business
Strong understanding of internal controls through review of company procedures and policies
MS Office knowledge and internet skills required
Periodic travel may be required. Requires schedule flexibility (including nights, weekends, and some holidays); fast-paced and dynamic

155

QC Analyst Resume Examples & Samples

Performs Quality Control (QC) biological/cell based testing of Cell Therapy and viral products release and stability samples. Typical test methods performed include, but are not limited to, flow cytometry, proliferation, ELISA, cell counts (manual and automated), cell based assays, and immunofluorescence microscopy/spectroscopy
Write original and revise current SOPs, Forms and Test Records. Writes edits and approves deviations and CAPAs as required. Responsible for initiating change controls and completing necessary documentation
Participates in cell therapy technology transfer activities and validation of analytical methods including training on new methodology, setup of new equipment, generation of method standard operating procedures (SOPs), and execution of validation protocols
Initiates out of specification (OOS), cell review committee (CRC), and deviation investigations as needed to address non-conformances in the lab
Orders supplies and reagents and performs general lab and equipment maintenance duties

156

QC Analyst Resume Examples & Samples

Previous GMP experience preferred in a QC or AD environment
Experience testing on HPLC systems (Waters/Agilent), UVIS, pH, TOC, Endotoxin and other assays
Ability to work in a high-throughput, fast paced laboratory environment
Comfortable making changes in prioritization of activities over the course of the shift
Previous experience in Reviewing assays and Training peers is preferred
Knowledge in use of TrackWise is nice to have but not a requirement

157

QC Analyst Resume Examples & Samples

Conduct stability studies activities
Perform hands on laboratory testing of stability products
Compile stability data and perform basic failure analysis according to procedures
Generate stability summaries/graphs
Organize, maintain, review stability batch records
Organize, maintain, inventory incubators to ensure stability storage capacity for upcoming studies
Revise and update minor changes to testing procedures, work instructions, and worksheet for correction or process improvement
Assist in reference materials production activities as needed
Assist in equipment maintenance/calibration activities as needed
Bachelor in a scientific discipline, preferably in molecular biology/biochemistry field
Minimum 1 year of quality control/manufacturing testing experience
Able to work independently and interface effectively with multiple disciplines within as well as external teams
Strong multi-tasking and attention to details skills
Proficiency with Microsoft office tools

158

QC Analyst Resume Examples & Samples

Analyzing raw material, and finished products completely
Handle in process testing with good understanding of the reactions running spikes
Analyze the finished products testing with client specifications and client’s methods
Completely the paperwork and reports to the production
Follows standard operating procedures for testing
Maintain and run instruments as per supplier instructions or laboratory procedures
Write all the results in well-maintained records for good documentation
Works with good hands and clean habits according to GLP and safety regulations
Set up instruments with good understanding
Records all the data on worksheets and instruments logs
Keep the instruments clean and in good working order
Good ability to run computers for handling instruments and performing simple operation
Work in any shift or off-hour shift as per requirement of the company
Interact and support production, R&D, and management everyday
Give results in a professional manner
Comply with all applicable regulatory requirements as needed by the company
BS degree in Chemistry, Chemical or other technical related field with 3+ years experience, or AA degree with 6+ years experience, or MS degree with 1+ year of experience. Experience defined as consisting of analytical testing in support of QC testing in an R&D lab setting

159

QC Analyst Resume Examples & Samples

In accordance with test method SOP’s, perform chemical analyses of including pH, conductivity, SDS-PAGE, Western blot, HPLC, ELISA, potency tests, and Spectrophotometric tests
Investigate, assess, and troubleshoot analytical and/or equipment problems
Notify QC Manager immediately when a deviation, an aberrant result, or an OOT/OOS result is discovered. Initiate and participate in authoring investigation report
Participate in all method qualifications, validations, and transfers including authoring protocols, project planning, execution, data analysis and report writing
Participate in method development including testing to support development of system suitability and assay controls. Authoring of related protocols and reports
Maintain sample tracking and integrity at all times until analyses are reviewed. Provide guidance to other analysts and communication to management

160

Senior Qc Analyst Resume Examples & Samples

Looking to onboard 6/26
Use standardized testing methods, tools and procedures to ensure testing is efficient, effective and comprehensive
Adhere to a unified team process
Translate requirements into detailed test plans and test cases
Develop test automation approach applying most modern test automation techniques
Design and create test scripts to address areas such as database impacts, software scenarios, regression testing, negative testing, error or bug retests, or usability in preparation for release
Ensure proper version control and configuration management of all test objects developed and test environments used
Execute manual/automated test cases/scripts
Perform tests in terms of functionality, reliability, stress, and compatibility
Create and maintain an automated build verification (smoke) test Document, troubleshoot, track and resolve requests and issues on a timely basis
Ensure web applications are cross-browser/cross-platform compatible and respond accordingly to compatible devices and tablets
Work with users to support User Acceptance Testing, Training, and more
Advise Test Manager/Project Manager regarding overall quality of project and state of work
Raise outstanding issues through established project management channels, as per project plan

161

QC Analyst Level Resume Examples & Samples

Use of HPLC systems (Waters and Agilent) - Titer and other similar assays - experience with associated software such as ChemStation or Empower
Use of spectrophotometers (UVIS and enzymatic assays)
Experience with TOC and Endotoxin assays
Working knowledge of LIMS, TrackWise or other similar systems
Ability to seamlessly change priorities and work in a high throughput, fast paced environment
Prior GMP experience (3-5+ years in industry)
Excellent ability to speak publicly
Begin to mentor other analysts
Excellent ability to communicate in both written and verbal format

162

QC Analyst Resume Examples & Samples

Record GMP data, monitors and evaluates QC systems and equipment
Implement improvements to procedures, and revises SOP’s and GMP documentation as required
Interact with internal and external auditors including government agencies and contract manufacturing representatives
Perform sterility and endotoxin testing for release, stability, and validation for raw materials, in-process and final products
Maintain Sterility and Endotoxin testing areas in a state of cGMP compliance
Perform and review growth promotion testing data for qualification of microbial culture media
Perform microbial identification related to product and environmental testing
Perform sampling of raw materials as required for QC testing
Perform routine quality control testing as required and monitors or evaluates systems, equipment (i.e. water systems, environmental chambers, sample collection and testing instruments/equipment)
Maintain records in paper based or computer based systems
Author and execute method validation/suitability protocols related to product testing
Author summary reports for executed method validation/suitability protocols
Author deviation reports and microbiological assessment reports related to departmental activities and product testing
Review Microbiology testing data as required
Coordinate receipt of raw material, in-process and final product samples for testing
Maintain metrics for receipt and processing of samples for microbiology testing
Provide technical input on product testing issues and instrumentation/equipment
Serve as liaison to service, calibration and technical representatives
Conduct and document assay failure and complaint investigations
Experience in pharmaceutical microbiology and microbiology testing not limited to endotoxin, method validation, sterility, bioburden, microbial identification, growth promotion and environmental monitoring testing; ability to perform standard and non-standard microbiology techniques to analyze product
Proficient at following specific instruction (i.e. written SOPs)
Working knowledge of cGMP/GLP
Good computer skills including word processing and working with spreadsheets
BS in related scientific field preferred
2-4 years related experience

163

QC Analyst Resume Examples & Samples

Gathers data and documents test results
Performance of Raw Material sampling within a clean room environment
Sample management
May devise or develop new analytical methods and techniques
May assist in validation of methods
A third level qualification in a scientific/technical discipline
Previous hands-on work experience in a regulated QC laboratory-testing environment within the biopharmaceutical industry would be a distinct advantage
Excellent Communication skills, both verbal & written
Collaboration and team work. Maintains the highest standards of ethical behaviour
Strong analytical ability and associated problem solving

164

Lead QC Analyst Resume Examples & Samples

Perform a wide variety of bioanalytical testing to support in-process and bulk drug substance release
Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs)
Participates in required training activities
Assist in the continuous expansion of the QC laboratory and selection/ implementation, qualification and calibration of laboratory instruments as needed
Interacts with outside customers or functional peer groups
Conduct laboratory investigations and generates reports in response to invalid assays, Deviations, OOS/OOT
Initiate and complete CAPAs and Change Controls in accordance with site procedures
May devise or develop new bioanalytical methods and techniques
Participates in the transfer of methodology from other test facilities
A third level qualification (BSc degree or higher) in biochemistry, biology, chemistry or related field. Preferably with 5+ years hands-on work experience working in laboratory to cGMP regulatory guidelines within the biopharmaceutical industry
Experience with electronic systems such as LIMS, Empower, SoftMax, Qumas, eDoc, Trackwise etc., is an advantage
Adaptable and flexible, willing to travel when needed
Results and performance driven
Good time management and attention to detail
Knowledge and proficient in the use of Microsoft products including, Excel, Word and Powerpoint

165

QC Analyst Resume Examples & Samples

Conduct routine chromatographic (HPLC and GC, but primarily HPLC) and wet chemistry testing of raw materials, in process, finished product and stability samples in strict compliance with GLP & cGMP procedures
Assist in the transfer (and troubleshooting, where required) of analytical methods into the QC laboratory as and when required
Assist in chromatography and wet chemistry training of other QC analysts
Troubleshooting analytical methodologies
Review QC data (wet chemistry, basic and more complex chromatography) as assigned
Conduct calibration and maintenance of wet chemistry/chromatography instrumentation
Participate in department projects, as assigned by QC Team Leader/QC Manager
Minimum of a Bachelor's degree (or equivalent) in a Science related discipline (preferably Chemistry) and 5 - 7 years of relevant industrial experience

166

QC Analyst Resume Examples & Samples

Microbiological testing
Perform chemical assay of solutions as well as general laboratory maintenance
Inspection and testing of raw materials, intermediates and final product
Environmental monitoring of clean rooms and water system
Develops and revises SOPs and trains appropriate employees
Maintains a working inventory of all components and archived materials and solutions
Writes and executes testing studies of finished products and components
Assist as needed in test method validation, implementation, and execution
Provides database support, generate reports and analyze process data
Assists Quality Assurance in document review and revision
Assist in Out of Specification (OOS) Investigations, Non-conformances, and Corrective Action/Preventive Actions (CAPAs)
Investigates and reviews Nonconforming Material reports
Assist in preparing for and participating in FDA audits, customer audits, etc
Demonstrate excellent organizational and time management skills
Bachelor’s degree in the biological or chemical sciences or equivalent
0 - 3 years experience in medical device, pharmaceuticals, or other regulated product preferred
Working knowledge of standard laboratory practices and safety
Ability to follow instructions precisely, recognize deviations, and recommend corrective action
Exercises sound judgment and decision making when problem solving
Experience with Microsoft Office software to create reports, spreadsheets, analyze data and prepare presentations

167

QC Analyst Resume Examples & Samples

Supervise the day-to-day operations of assay testing in QC. Ensure sample collection and testing is executed as scheduled. Review completed assays for accuracy. Communicate with management regarding test results
Responsible for training and supervising analysts performing QC assays according to SOP and CGMP
Oversee the maintenance of lab supplies and reagents and the proper disposal of hazardous material
Perform or supervise “special” testing, including assay validations according to SOP or protocol
Responsible for generating monthly and annual control logs for all assays performed in the Screening Laboratory. Analyze control log data for potential assay trends. Report assay trends abnormalities to the Laboratory Manager
Qualify new standard, controls, reagents and materials when necessary
Provide technical support for laboratory staff. Troubleshoot assays as necessary
Provide annual retraining to Laboratory staff. Document such training
Investigate Laboratory incidents/deviations and write deviation reports
May assist in the development of new assay procedures
Write and revise SOPs as necessary; Perform annual reviews of SOPs
Assists in writing validation protocols and final validation reports
Analyzes data by statistical and graphical procedures in order to provide pertinent summaries/reports of large volumes of data
Prepares written/oral reports for presentation to supervisor or Laboratory staff
Performs additional job related duties as required
Requires a bachelor’s degree in Biology or related field with a minimum 5 years of relevant experience or equivalent
Ability to follow instructions precisely , recognize deviations, and recommend corrective action
Prior experience in a cGxP regulated environment. Strong working knowledge of cGLP and cGMP regulations
Demonstrated ability to train and supervise others
Ability to conduct complex troubleshooting
Computer literate and proficient in MS Word, Excel and other relevant electronic systems
Strong critical thinking, time management and organizational skills. Demonstrated ability to multitask and consistently meet deadlines
Possesses well developed attention to detail, ability to maintain accurate records and excellent proofreading skills
Excellent written and verbal communication skills. Ability to communicate effectively (up, down, and laterally) with others
Demonstrated initiative through past experience
Ability to work effectively both independently and as a member of a team
Requires ability to work flexible, and, at times, extended work hours to meet business needs

168

Fixed Term QC Analyst Resume Examples & Samples

Preparation and testing of In-Process / Finished Product samples, Raw materials and/or environmental monitoring/water samples in accordance with written procedures and best practice
Daily up-keep and maintenance of Laboratory Equipment
Accurate and timely recording of all information pertinent to the task being performed in the relevant Laboratory Worksheets / Notebooks and LIMS

169

Senior Qc Analyst Resume Examples & Samples

The analysis of raw material, in process, finished product and stability batches
Reviewing analytical data, reports and performing peer review
Approval of analytical data, and performing batch release from the QC laboratory where necessary
Investigation of atypical and out of specification / out of trend results and completion of laboratory investigation reports and incidents through use of Trackwise
Providing technical and analytical support for your team in adherence of testing schedules
Calibration, qualification and trouble shooting of all laboratory instrumentation
Generation and review of laboratory documentation – Protocols / SOP’s / validation and transfer documentation / stability documentation
Undertaking non-routine investigations and complex projects
Providing support to team, training team members and act as a mentor to less experienced analysts
Provide any support necessary to QC Supervisor and deputize all aspects of QC Supervisor role and responsibilities in their absence
Minimum of a Bachelor of Science Degree
Minimum of 3 years’ relevant experience in a laboratory environment
Proven competence in raw material, finished product and stability testing with an excellent personal R.F.T record
Proven competence and trouble-shooting capability of all O.S.D laboratory instrumentation and techniques
Broad QC experience including testing, data review, method validation and transfer, instrumentation use, stability testing and quality systems experience relating to QC laboratories
Strong knowledge of operation, calibration, qualification and maintenance of laboratory equipment
Must have effective problem solving and technical skills and excellent communication skills
Self-motivated, hard-working, positive attitude, able to prioritize and proven record of innovation and introducing operational improvements in QC laboratory environments

170

QC Analyst Resume Examples & Samples

Performs and documents laboratory testing and data analyses of raw materials, manufacturing intermediates, finished products, and control materials
Conducts data analyses according to established methods and product specifications
Revises and updates product testing procedures, work instructions, and worksheet as appropriate
Performs laboratory and equipment maintenance/calibration activities as instructed
Maintains laboratory reagent and control material inventories
Participates in test method validation activities
Participates in product investigations
Bachelor’s degree in molecular biology, biology, microbiology, chemistry, biochemistry or similar scientific discipline
0 to 2 years of Quality Control and/or Manufacturing testing experience
Experience working in a 21CFR Part 820 compliant environment

171

QC Analyst Resume Examples & Samples

Receive samples and documents transactions thoroughly in Laboratory Information System (LIMS)
Deliver samples to QC lab for testing as required
Perform Sample Management tests as set forth in OJT tracker
Ensure compliance with SOP’s; reports any quality or other anomalies through Deviation Notification and Resolution
Writes and revises controlled SOPs and Work Instructions as directed
Completes submission records and reviews data
Verifies calibration of instruments/devices prior to use
Perform shipping of samples as per requests
Maintains a clean work environment
Performs sample disposal, sample inventory, and temperature checks as required

172

QC Analyst Resume Examples & Samples

This is a 2nd shift position.**
Perform a wide variety of bioanalytical testing to support on raw materials, in-process, product, stability, and/or research samples
Perform Capillary Gel Electrophoresis, Charge Variant analysis, SDS-PAGE and Western Blots etc
Conduct laboratory investigations and generates reports in response to invalid assays, deviations, OOS/OOT
Experience with electronic systems such as LIMS, Empower, Qumas, eDoc, etc. and statistical analysis would be an advantage
Strong collaboration and team working skills
Results and performance driven while maintaining the highest standards of ethical behavior
Strong analytical ability and associated problem solving skills
Strong proficiency in the use of Microsoft products including, Excel, Word and PowerPoint
Requires BS/BA in Biology Sciences or related field for level I
For a level II or higher, a minimum of 2+ years’ relevant experience, preferably working in a cGMP pharmaceutical environment, is required
May substitute relevant experience in lieu of educational requirement

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