Analyst, QC Resume Samples

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R Funk

Ricardo

Funk

638 Raphael Garden

Boston

+1 (555) 411 4635

638 Raphael Garden

Boston

Phone

p +1 (555) 411 4635

Experience Experience

San Francisco, CA

Analyst, QC

San Francisco, CA

Dicki and Sons

San Francisco, CA

Analyst, QC

Work with other departments in developing, revising and implementing QC procedures and policies
Perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results
The ELISA/Potency specialist will perform ELISA's, residual DNA analysis, and Endotoxin by LAL
Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next
Perform water sampling and testing, raw material inspection and identity testing HABA testing and electrophoresis (SDS-PAGE and IEF)
Formulate buffers and reagents for the purpose of performing test methods
Performs routine and product release testing

Philadelphia, PA

QC Micro Analyst

Philadelphia, PA

Vandervort-Raynor

Philadelphia, PA

QC Micro Analyst

Performs biological and endotoxin indicator testing used in the validation of manufacturing equipment
Performs peer review of data
Performs laboratory investigation reports
Performs microbial identification procedures
Uses Laboratory Information Management System (LIMS) for sample and sample test result tracking
Performs microbiological testing of in-process and final product materials
Performs bioburden and endotoxin testing of products and raw materials

present

Dallas, TX

QC Micro Senior Analyst

Dallas, TX

Hackett-Dietrich

present

Dallas, TX

QC Micro Senior Analyst

present

Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation
Continuous Improvements - Responsible for supporting a culture of Continuous Improvement by using Merck Six Sigma tools within the CoE in your daily work
Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data, and support them once made
Delivery of area performance to meet or exceed functional unit goals
Collaborate - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new Merck
Co-ordination and Implementation of Continuous Improvement Initiatives
Implementation of Lean Labs

Education Education

Bachelor’s Degree in Biochemistry

Kaplan University

Bachelor’s Degree in Biochemistry

Skills Skills

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
Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices
Demonstrated working knowledge related to specific functional activities
Ability to perform most tasks with supervision
QC cGMP experience beneficial
2) Tuesday - Saturday schedule
1) Sunday - Thursday schedule

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QC Appraisal Analyst Resume Examples & Samples

Minimum of 5-10 years of residential appraisal review background, leadership background and/or quality control/audit background. Candidates do not have possess all three but would need to be strong in at least one
Desired knowledge of appraisals principals and procedures
Desired knowledge of regulatory requirements
Working knowledge of bank products and credit lending services
Working knowledge/experience with Microsoft Suite ie Excel, Word, Powerpoint, Access
Strong time management and organizational skills with ability to manage multiple priorities
Sound judgment and independent decision making skills
Ability to work independently but interact in a team-oriented environment

QC Credit Analyst Resume Examples & Samples

A BS/BA degree is preferred
3+ years quality assurance, quality control, or similar mortgage experience required
Strong understanding of mortgage documentation and compliance requirements i.e. allowable fees, GFE to HUD1 comparisons, exception tolerances
Mortgage Post-Closing Audit experience a plus
Proficient with Microsoft – Access, Excel, Word & Outlook
Team oriented with ability to interact with all levels inside and outside of the organization
Able to handle multiple priorities and meet deadlines in a fast-paced environment

QC Bioanalytical Analyst Resume Examples & Samples

Requires a Bachelor’s degree from an accredited college/university according to the Council for Higher Education Accreditation (CHEA) in a scientific discipline or four (4) years of experience in lieu of degree
Knowledge of Good Laboratory Practices (GLPs) and current Good Manufacturing Practices (cGMPs)
Ability to follow SOPs of simple to complex technical content and comply with cGMPs/GLPs
Extensive experience bioanalytical methods such as liquid chromatography systems to include HPLC and UPLC technologies, DNA analysis by PCR, ELISA, Gel Electrophoresis SDS-PAGE, and Western Blot. Strong technical writing skills
Cleanroom and BL2 experience
Ability to lift up to 35 pounds
Experience with and/or knowledge of method qualification/validation, protein analysis, DNA analysis, or other large molecule experience
Experience with method transfer activities
Method development, instrument maintenance, and instrument and method troubleshooting

QC Micro Analyst Resume Examples & Samples

This is a 2nd shift position**
Reviews and updates SOPs
Performs peer review of data
Performs laboratory investigation reports
Participates in training of other employees
Performs microbial identification procedures
Maintains laboratory supplies, media, and reagents inventory
Performs bioburden and endotoxin testing of products and raw materials
Performs microbiological testing of in-process and final product materials
Performs biological and endotoxin indicator testing used in the validation of manufacturing equipment
Updates microbiological environmental monitoring results database and prepares monthly report
Performs acceptance testing of commercially prepared microbiological culture media
Assists in coordinating equipment maintenance and calibration
Uses Laboratory Information Management System (LIMS) for sample and sample test result tracking
Performs all duties relevant to the Quality Control Microbiology Technician position as required
Increasing involvement in the training of employees
Increasing responsibilities for reviewing documents and data
Microbiology representation and participation in cross functional site meetings
Administration of programs such as gowning, training, ordering, calibration, etc
Technical writing assignments such as SOPs, protocols, final reports, trend reports, risk assessments, laboratory investigations, etc
Ability to organize and maintain data or information
Ability to learn through observation and hands on experience
Requires BS/BA in Life Sciences or equivalent along with relative experience for levels beyond I (preferably in the pharmaceutical or biotechnology industries ). Will substitute relevant work experience in lieu of degree requirement

QC Bioanalytical Analyst Resume Examples & Samples

A minimum of (5) years related experience
Knowledge of general analytical laboratory techniques, and specific techniques such as chromatography, PCR, ELISA, or electrophoresis
Experience with and/or knowledge of method qualification/validation, protein analysis, DNA analysis, or adenoviral vector analysis
Hands-on experience with testing methods such as HPLC, spectrophotometry, western blots, bioassays, and ELISAs, and basic cell culture techniques

Analyst, QC Resume Examples & Samples

Analysis of environmental, raw material, in-process and final bulk product samples according to Standard Operating Procedures and Test Methods
Problem solving of analytical methods as well as troubleshooting of equipment will also be performed as the employee advances from one level to the next
Advancement from one level to the next is based on evaluation parameters listed for each level
Performs routine and product release testing
Author or update existing SOPs and TMs as needed
Troubleshoot equipment/methods
Train other analysts on methods
Prioritize workload
Review routine data with supervisory audit
Microbiology/EM Area: Understanding and execution of basic micro. and intermediate techniques (bioburden, LAL, plating and counting techniques, etc.). User of some advanced techniques (ID)
Analytical/Biochem Area: Understanding and execution of basics for spectroscopy, assigned methods which may include chromatography methods, Elisa, PCR, osmolality, potency methods, appearance and other physiochemical methods
Raw Materials Area: Understanding and execution of compendial monographs, chemistry fundamentals behind methods. Technology/equipment may include IR, polarimetry, refractometry, density meters, titrations (manual and automatic), Atomic Absorption, wet chemistry techniques

QC Virology Analyst Resume Examples & Samples

Proficient in cGMP practices in all aspects of laboratory assignments
Collect, process and report on data for samples associated with in-process testing for the clinical and/or commercial manufacturing facilities
Apply basic and advanced troubleshooting methods
Perform cell culture activities to support virus testing
Serve as SME for an assigned assay
Assist in data trending, data review, and lab maintenance activities (e.g. cleaning)
Participate in non-routine projects
Apply knowledge to assist in investigations and support studies and protocols
Responsible for collecting, entering data and generating reports from electronic systems
Follows established safety and environmental guidelines and procedures for all work performed. Immediately reports safety and environmental incidents including injuries, illnesses, near misses, and safety suggestions. Fosters a positive safety culture in which no one gets hurt
Some working knowledge in PCR, cell culture, and virus and mycoplasma will be a plus
Demonstrate excellent organizational skills (multitask)
Ability to write, read and follow Standard Operating Procedures
Must be able work independently as well as within a team in a fast pace environment
BS/BA or MS in Cell Biology, Microbiology, Biochemistry, or related Science
1-3 years working in GMP virology or cell culture lab or related experience (with molecular biology knowledge)
Work in Labs that require gowning and no make up or jewelry
Available to work over-time, weekends, and holidays as needed

QC Laboratory Shift Analyst Resume Examples & Samples

Analytical testing on raw materials, intermediates and finished products
Maintaining accurate records
Participation in continuous improvement teams/projects
Maintaining supply inventory for daily operations

QC Biologics Senior Analyst Seperations Resume Examples & Samples

Ensuring compliance with corporate policies, directives and current regulatory requirements for finished produce release testing and good documentation practices within the laboratories
Liaising with sister sites to ensure consistent data reporting and trending practices
Co-ordinating local site and global activities to support routine testing and method transfer/validation testing requirements
Batch paperwork review, and reconciliation of analysis performed in laboratory
Participate in troubleshooting complex analytical and instrumentation issues
The ownership of change controls in the area
The successful candidate will hold a minimum of a BSc in biochemistry or related discipline
A minimum 7 years Quality experience in a bio-pharmaceutical operation, at least 3 of which should be hands on experience in a Biologics GMP laboratory setting
A strong fundamental understanding of protein biochemistry is desirable
Technical expertise should include the following Biopharmaceutical analytical platforms (HPLC/UPLC, CE, cIEF)
Experience with laboratory data systems (Empower, LIMS) is essential
Ability to work independently in assay and recognize anomalous trends or results

Analyst, QC Resume Examples & Samples

Analysis of bulk product, in-process, raw material or environmental samples according to
Standard Operating Procedures and Test Methods
Involvement in method transfers and validation
Involved in equipment qualification and technical selection of QC equipment and/or standards and reagents
Assay trend analysis
Microbiology/EM Area: Understanding and execution of intermediate and advanced microbiology techniques (bioburden, LAL, plating and counting techniques, microbial identification, etc.). Generation of required trending and reporting information. Assist in process and/ or environmental microbiology related investigations as required
Analytical/Biochemistry Area: Understanding and execution of spectroscopy, and other assigned methods which may include chromatography methods (HPLC), ELISA, PCR, osmolality, potency methods, appearance and other physiochemical methods
Raw Materials Area: Understanding and execution of compendial monographs and the chemistry fundamentals behind methods. Technology/equipment may include IR, HPLC, GC, polarimetry, refractometry, density meters, titrations (manual and automatic), atomic absorption, wet chemistry techniques
Degree/Diploma in a relevant Science field or Equivalent
Relevant experience and accomplishment to dictate final position for which the candidate may qualify

QC Biologics Analyst Resume Examples & Samples

Assisting in updating and issuing documentation, including SOPs, as required
Performing routine data analysis, assist in the investigation of OOS results, perform trending analysis and writing investigation reports
Accurately documenting laboratory work
Execute and assist in batch release testing, technical transfer and co-validation activities
Assisting with qualification of laboratory instruments
Perform instrument performance checks and calibration
Assist with troubleshooting of instrumentation
Data review based on demonstrated proficiency on assays
Some experience in the following analytical techniques would be an advantage: Aseptic Techniques, Cell Culture, Cell-based Bioassays and ELISA
The ideal candidate should hold a minimum of a BSc. in Biochemistry or related discipline
The successful candidate must demonstrate an ability to work independently in assay execution and recognize anomalous trends or results
The successful candidate must demonstrate problem solving ability, as well as the ability to prioritize objectives from multiple projects and adhere to scheduled timelines
Excellent communication and the ability to work in a team based collaborative environment are required

Analyst, QC Resume Examples & Samples

Perform basic compendial test methods without supervision and with strict adherence to written protocols, analyze data and report results
Formulate buffers and reagents for the purpose of performing test methods
Write and revise test methods and procedures
Perform aseptic sampling, visual inspection, pH, conductivity, osmolality, and spectrophotometry
The ELISA/Potency specialist will perform ELISA's, residual DNA analysis, and Endotoxin by LAL
Perform water sampling and testing, raw material inspection and identity testing HABA testing and electrophoresis (SDS-PAGE and IEF)
Perform QC testing for lot release, stability, development/validation projects, and investigations
Oversee stability studies for one or more product lines, raw material testing and release, water sampling and testing
Other functions include writing study protocols and reports
Work with other departments in developing, revising and implementing QC procedures and policies
Should be aware of company cGMPs as well as industry regulations that apply to all job functions

QC Virology Analyst Resume Examples & Samples

Support contract lab testing program for cell bank and unprocessed bulk (work with various team to coordinate sample handling and shipment, and tracking samples and tests with contract laboratory)
Support commissioning activities for a new virology (+Mycoplasma) testing lab at Regeneron Pharmaceuticals, Inc. (ordering of equipment, supplies and reagents and managing inventory)
Support validation of virology and mycoplasma test methods
To ensure a safe and contamination free environment, employees who are required to enter a clean room must remove all street clothing except socks and undergarments before changing into clean room approved gowns. This includes, but is not limited to, head gear, makeup, jewelry and exposed piercings, and non-sanitizable medical equipment
Requires BS/BA in Cell Biology, Microbiology, Biochemistry, or related Science
Requires 5+ years working in GMP virology or cell culture lab or related experience (with molecular biology knowledge)

QC Bioassay Analyst Resume Examples & Samples

Analysis, release and testing of samples of Keytruda
Documentation in compliance with GMP standards
Basic knowledge of computer programs such as MS Word, Excel and Access

Analyst, QC Raw Materials Resume Examples & Samples

Perform, under direct supervision, chemical and biochemical analyses of incoming raw materials under cGMP to meet specified timelines
Evaluate results and trend data
Maintain raw materials log and control of laboratory inventories
Coordinate and track outside laboratory testing activities
Participate in the preparation of investigations, summaries and reports
Participate in method validation, develop/write procedures and troubleshoot assays
Maintain the laboratory in an inspection ready state
Must have a quality service attitude and be willing to work additional hours to meet production or laboratory requirements when necessary
On rare occasion, provide on call coverage for Out of Specification conditions to support production testing and quality control laboratory equipment
Must have a positive, team minded personality
At least one year in a cGMP laboratory and quality control experience beneficial, but not required
Experience in quality control practices, current Good Manufacturing Practices or Good Laboratory Practices preferred
Demonstrated working knowledge related to specific functional activities
Ability to perform most tasks with moderate supervision
Computer literacy is required
Experience with Microsoft Word and Excel required; experience with Labware LIMS, O365 a plus
Must have excellent record keeping, written and verbal skills
Work in a GMP laboratory and be compliant with the laboratory procedures
May work with biohazardous materials, hazardous chemicals, and radioactive materials
Comfortable lifting 50 pounds
Ability to work independently and to deal with multiple tasks
May be required to work second shift, overtime, weekends and holidays
Moderate supervision and minimal guidance should only be necessary for specific ad hoc assignments
Organizational skills as well as good written and verbal communication skills essential
Must work effectively as a member of the BioMarin team
Must have a Quality service attitude and be willing to work additional hours to meet deadlines and requirements
Experience in a cGMP laboratory; quality control experience beneficial
Familiarity/experience with Compendial testing (USP, EP, JP) preferred
Familiarity/experience with complex instrumentation (HPLC, GC) preferred
Familiarity/experience with Labware LIMS preferred

QC Micro Analyst Resume Examples & Samples

A Bachelor's degree (B.S.) or equivalent experience in Microbiology or related life sciences field with 1 to 3 years of relevant/ industry experience or equivalent combination of education and experience
Knowledge of cGMP and USP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH)) pertaining to QC micro programs that support production of APIs, water testing and environmental monitoring
Ability to follow protocols, assist in writing reports and assist in revising procedures and methods
Experience performing Endotoxin, Bioburden, TOC, and UV analysis
Ability to apply advanced mathematical concepts
Knowledge of and skill in using basic computer software and hardware applications, including Microsoft Word and Excel
Ability to multi-task and manage various projects and competing priorities: must be able to use individual discretion in completing work assignments, assists the group in establishing priorities, setting standards and working collectively to meet project deadlines and objectives

QC Chemistry Analyst Resume Examples & Samples

Routine testing to support analytical laboratory
Using multiple analytical methods including HPLC, Spectrophotometer, analytics, pH, raw materials
Executes test methods, tabulate data and provide data interpretation
Troubleshooting in support of investigative testing may be required
Assist in revision of test methods, LIMS builds and creation of training materials as necessary
Exposure to analytical methods (HPLC, Spectrophotometer, analytics, pH, raw materials)
Ability to work in a fast paced team-oriented setting
At least 1-2 years of QC analytical experience
Authorization to work in the United States indefinitely without restriction or sponsorship

QC Systems Analyst Resume Examples & Samples

Participate on departmental/interdepartmental/global teams, process improvements
Minimum 3-5 years work experience in biopharmaceutical production and an understanding of the quality processes and procedures
Working knowledge of one or more information packages (Quality Systems, LIMS, EDMS, CDS or ERP). Experience with problem-solving and issue identification and resolution
Applies company knowledge and solid technical expertise to complete moderately complex assignments within defined parameters. Demonstrates a solid understanding of Genentech and the functional organization being supported. Thoroughly skilled in assigned functionality

QC Biologics Analyst Resume Examples & Samples

Performing release testing for biological products
Execute and assist in technical transfer and co-validation activities
2-3 years’ experience in a regulated biopharmaceutical laboratory is essential. HPLC/UPLC and Empower experience is required
The successful candidate must demonstrate an ability to work independently in assay and recognize anomalous trends or results

Analyst, QC Chemistry Resume Examples & Samples

Required Competencies: Knowledge, Skills, and Abilities
Perform various wet chemistry and analytical chemistry methods
Follow methods and procedures, with strict adherence to cGMP documentation requirements
Complete all work assigned in a timely manner
Work and communicate effectively within the team to ensure timelines are met
Report all identified problems to designated senior personnel and assist them with
Thoroughly document justification for all changes being made
Prepare various solutions needed to support method performance; for example, mobile phase,
Education and Experience
High school diploma or equivalent required
1 year relevant work experience required, preferably in a regulated industry
An equivalent combination of education and experience may substitute
This position requires regular medical surveillance and may require incumbent to wear a
The incumbent must analyze numerical values on a daily basis
The incumbent will be working a laboratory setting up to 6 hours per day
The incumbent will occasionally be working around hazardous materials to include chemical

Configuration Analyst, Maintenance QC Resume Examples & Samples

10%: Act as a data steward for the maintenance tracking system by defining and establishing best practices for configuration of aircraft, systems, and rules within the maintenance tracking system to ensure compliance with FAA, NetJets, and OEM programs & documentation while facilitating operational efficiency
Outstanding analytical & problem-solving abilities
Familiarity with aircraft systems and data
PC skills, including MS Office Suite (Word, Excel, PowerPoint, etc.)
Experiennce with Excel Macro's (VB)

QC Micro Senior Analyst Resume Examples & Samples

Co-ordination of analysis, release and testing of samples
Operational Testing and ATT (if applicable)
Scheduling of Laboratory activities
Training of Laboratory personnel
Delivery of area performance to meet or exceed functional unit goals
Co-ordination and Implementation of Continuous Improvement Initiatives
Ensure compliance with safety, health, environmental and cGMP and other applicable regulations
Implementation of Lean Labs
Participate in corporate and regulatory audits
Continuous Improvements - Responsible for supporting a culture of Continuous Improvement by using Merck Six Sigma tools within the CoE in your daily work
Coaching and Training - Coaching others by sharing your skill-set and expertise
3rd level Degree in Science or related discipline
Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc). Bioassay and/or cell culture experience is highly desired – if applicable
At least three years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a QC Laboratory / Bioassay Laboratory or equivalent – as applicable
Demonstrated high level of scientific problem solving and facilitation skills
A good knowledge of cGMP, GLP, site and corporate Quality Systems
Knowledge of working practices required for a Bioassay laboratory (e.g. good aseptic techniques, cell culture, etc) – if applicable
Ability to plan and organize effective and efficient work schedules
Ability to set and maintain high standards of laboratory housekeeping
Ability to respond to changing priorities
Demonstrated ability to fully realize improvement initiatives
PC skills such as Excel, Word, PowerPoint

QC Raw Mats Analyst Resume Examples & Samples

Ensure highest Quality & Compliance standards
Documentation in compliance with GMP and GDP standards
Responsible for supporting a culture of Continuous Improvement by using MSD Six Sigma tools in your daily work
Coaching and collaborating with others by sharing your skill-set and expertise
Knowledge of working practices required for a Chemistry / Raw Materials laboratory
Excellent work ethic required
A good knowledge of cGMP, GLP, Quality Management Systems
Demonstrate knowledge in more than one pharmaceutical / biopharmaceutical or chemical manufacturing operation
A minimum of 06 months experience in the Bio or Pharmaceutical industry or a similar operating environment which includes experience in a QC, Tech Ops, or similar Laboratory

Analyst, QC Micro Resume Examples & Samples

Ability to deal appropriately with regulatory agencies
Ability to multi-task and work flexible work schedule
Intermediate written and verbal communication skills
Basic ability to interpret and write general business documents
Ability to follow direction, work cooperatively as an individual contributor and as a team member
Ability to gown and maintain a sterile work environment
Ability to work independently for extended periods of time
Basic proficiency in Microsoft Word, Outlook, and Excel
Basic knowledge of cGMP, OSHA, DEA, USP, and EP
Ability to pass an initial full physical with annual monitoring
Aseptic gowning
Media fills
This position involves being fully gowned for extended periods of time within a restrictive movement environment. This may include standing, bending, reaching, kneeling, balancing, pushing, pulling, lifting (NMT 25lb), or carrying (NMT 25lb)
This may also include concentrating, remembering names, effective verbal and/or written communication, analytical thinking, decision making, and adapting to change
This position works within controlled environments with strict gown and gloves requirements
This position involves working conditions with constricted personnel movements for up to 6hours a day
Definitions and Abbreviations
United States Pharmacopeia (USP)
European Union (EU)
Japanese Pharmacopeia (JP)
British Pharmacopeia (BP)
Occupational Safety and Health Administration (OSHA)
US Drug Enforcement Administration (DEA)
Personnel Protective Equipment (PPE)
1 year of relevant work experience required, preferably in a regulated manufacturing environment with cGMP requirements
An equivalent combination of education, experience and training may substitute

QC Bioassy Analyst Resume Examples & Samples

Problem solving to get to root cause of issues
Focus on Customers, Including Patients - Focus the entire organization on delivering value for customers, including patients, by understanding and meeting their needs
Collaborate - Actively listen and seek to understand differing perspectives; work together to achieve the common goals of the new MSD
Act with Candor and Courage - Speak openly, honestly and with conviction; have the courage to take appropriate risks and make difficult decisions
Make Rapid, Disciplined Decisions - Make timely decisions at the right level with the right data, and support them once made
Drive Results - Set clear performance standards; overcome obstacles; hold ourselves and others accountable for achieving results
Demonstrate Ethics & Integrity - Adhere to the highest standards of trustworthy and ethical behavior in all interactions and hold others to the same standards; comply with all laws, policies and regulations; identify and address ethical issues without hesitation
Demonstrated knowledge in more than one pharmaceutical and/or chemical manufacturing operation (e.g. Quality, Science etc). QC Bioassay laboratory experience is highly desired
At least two years experience in the Pharmaceutical industry or a similar operating environment which includes experience in a QC Laboratory or equivalent
Degree or 3rd level qualification in Science or related discipline
Preference for Lean Six Sigma Yellow Belt
Knowledge of working practices required for a Bioassay laboratory (e.g. cell culture, aseptic techniques, etc)
Good understanding of quality and good attention to detail