QC Manager Resume Samples

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L Watsica

Lavern

Watsica

8130 Roselyn Mount

Detroit

+1 (555) 496 7373

8130 Roselyn Mount

Detroit

Phone

p +1 (555) 496 7373

Experience Experience

Detroit, MI

QC Manager

Detroit, MI

Rogahn Inc

Detroit, MI

QC Manager

50% Management of daily/weekly/monthly and longer term activities of staff and operational oversight of group, data review, scheduling, oversight of group training
10-30% Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
50%: Management of daily/weekly/monthly and longer term activities of staff and operational oversight of group, data review, scheduling, oversight of group training
10-30%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Full responsibility for the operation of the laboratory; the quality of the testing provided, the safe maintenance of the equipment and the well-being of the staff
Manage and develop the Laboratory team
Ensure that quality systems are adhered to and accreditation is maintained and expanded

Philadelphia, PA

Cscs Project & QC Manager

Philadelphia, PA

Mosciski and Sons

Philadelphia, PA

Cscs Project & QC Manager

Preparing project schedules and performing project tracking and reporting
Performing progress tracking and reporting of issues, risks and mitigation plans and communicating progress
Identifying when actual performance deviates from agreed tolerances and escalating issues as necessary
Supporting the application of strategic project management initiatives
Management of CSCS activity in MyTalentWorld environment
Supporting the development of materials and content for Certified Modules
Tracking performance against budget and report any variances

present

Detroit, MI

Senior Site QC Manager

Detroit, MI

Ledner-Upton

present

Detroit, MI

Senior Site QC Manager

present

Provides supervision, training, development, and performance management of direct reports
Assists in the coordination of punchlist walkdowns/inspections; establishes and manages the punchlist
Develops and implements quality programs that assist projects and division to meet company and division quality goals and expectations
Develop and administer site specific Quality Programs
Establishes inspection plan and track inspections/actions identified
Approves site testing such as soils testing, concrete placement and grout breaks, hydro tests, and NDE testing and verify tests are properly documented
Responsible for issuance, control and coordination of Post Weld Heat Treatment (PWHT) and Non Destructive Examination (NDE) contacts

Education Education

Bachelor’s Degree in Engineering

University of Massachusetts Amherst

Bachelor’s Degree in Engineering

Skills Skills

Ability to work independently or on a team
Strong analytical and protein chemistry background
Strong presentation and communication skills
Ability to prioritize, manage multiple tasks, and meet deadlines
Level will be determined based on experience
Technical knowledge of materials and construction concepts
Proficient with database operations and Microsoft Office Suite
Ability to properly manage and prioritize resources, people and projects
Sound decision making ability with the experience to balance consensus against authority as appropriate
Team player, with strong leadership skills, who can operate effectively within a matrix management environment

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15 QC Manager resume templates

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Consumer QC Manager Resume Examples & Samples

Monitors individual and team productivity and quality, and provides feedback to Management
On a monthly basis, re-underwrites a random sample of loans completed by the Quality Control team; records deficiencies discovered throughout the course of the audit and evaluate the quality of the files audited
Responsible for assisting manager in the prioritization of work and delegation of tasks to ensure proper coverage of functions
Responsible for auditing complex transactions including special investigations, targeted, and high-risk samples
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 to provide research support for findings reported to management
Assists in analyzing error trends and identifies areas of interest for future policy, product, or guideline enhancements
Provide training for new Quality Controls Analysts
Communicates updates of underwriting guidelines, products and policies to staff
Prioritizes and oversees the monthly audit production to ensure compliance with Investor established timelines
Minimum 4 years advanced level mortgage or consumer bank government underwriting experience, including

QC Manager Resume Examples & Samples

50%: Management of daily/weekly/monthly and longer term activities of staff and operational oversight of group, data review, scheduling, oversight of group training
20-40%: GMP documentation related activities (ex. SOP revisions, quality systems related events, method related project documents as required), oversight of group metrics
10-30%: Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)
Ability to work around chemicals (if working around the laboratories)
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

QC Manager Resume Examples & Samples

Full responsibility for the operation of the laboratory; the quality of the testing provided, the safe maintenance of the equipment and the well-being of the staff
Manage and develop the Laboratory team
Proactively manage operations to meet customer's requirements by effective planning and day to day management of workflow and testing
Ensure that quality systems are adhered to and accreditation is maintained and expanded
Undertake 'root cause' analysis in the event of any failure
Frequently review staff training to ensure that that it meets the requirements of the laboratory and fulfil the needs and aspirations of the individual. To ensure training records and matrices are fully completed and up to date
Review ongoing development of method performance, validation and quality control systems
Increase the capability and range of testing provided by the Laboratory to support profitable growth
Provide a high level of customer service and maintain working knowledge of relevant legislation and industry standards and trends
Maintain lab KPIs, especially on time delivery, at exceptional levels
Monitor overdue samples daily and ensure any identified are promptly investigated and actioned
Exercise a sound commercial and financial awareness to help reduce expenditure and maintain costs within the required budget requirements
Work with senior management and staff to ensure that the best interests of the company and continual improvement of the quality systems are achieved
Ensure the up to date reporting of key performance indicators and management information to senior management
Degree in Science, Food Science or equivalent preferable to Masters level
Experience across a variety of analytical techniques
Chemistry and/or Microbiology Testing Experience
Testing within analytical & chemistry/microbiology laboratories
Lab methods and procedures
Drive Change Control & continuous improvement
Analysing Information, Strategic Planning, Informing Others, Emphasising Excellence, Attention to Detail, Thoroughness, Dealing with Complexity

Consumer QC Manager Resume Examples & Samples

Bachelor#s degree in business or related field or equivalent experience
Minimum of 3 years Consumer Lending, banking, or financial services experience
Minimum 2 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 2 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, underwriting, and closing functions and the ability to apply that knowledge in an audit function
Knowledge of Underwriting Program requirements
Knowledge of all documents used by the Bank in the origination of conventional and government loans
Knowledge of consumer lending regulatory and compliance experience across multiple states preferred
Ability to interact with all levels of management and external customers
Strong interpersonal, written and verbal communication skills
Ability to manage multiple priorities and tasks
Ability to work independently and in a team environment
Proficient with Microsoft Office programs such as Word, Excel, PowerPoint, & Access

Commerical QC Manager Resume Examples & Samples

Develop and manage a team that is responsible for reviewing critical functions to ensure all transactions and related processes have been performed in accordance with internal and external requirements
Perform investigative reviews and/or targeted reviews on processes having characteristics indicating a higher level of risk or fraudulent activity
Analyze findings/observations identified and assist with the implementation of action plans to resolve identified concerns
Stay abreast with industry best practices and the most up to date requirements around highly regulated processes
Communicate relevant regulatory and policy changes to the QC department to ensure procedural updates are made in a timely manner to meet change deadlines
Plays a key role in the planning, testing and implementation of process and project enhancements to ensure project plan requirements and are completed in a timely fashion; may act as project leader for projects
Reviews QC operational procedures and methods and recommends changes for improvement, with an emphasis on automation and efficiency
Provides input into the creation of detailed project plans, work assignments, target dates and other aspects of assigned projects
Influences leaders and peers across organizational lines to take action on strategic initiatives or process changes
Establishes the climate that encourages an open two-way channel of communication whereby team members exchange ideas / suggestions and share information
Reports regularly on progress against established project plans
Oversees the updating and production of manuals, standard business and status reports, technical training material and reference material
Performs aspects of Project Management including but not limited to Approval gathering, Readiness Assessments, and other artifacts and controls
Bachelor's degree in Business, Finance, or equivalent experience. Advanced degree preferred
Minimum of 10 years experience with banking operations and ability to demonstrate an understanding of all banking business lines
Minimum of 5 years of management experience of exempt and non-exempt personnel, including demonstrated experience in a project management capacity and/or Lean Six Sigma project execution
Knowledge of the fundamental concepts related to loan origination and retail transactions along with the ability to apply that knowledge in a Quality Control function
Knowledge of common and standard loan documentation and terminology
Knowledge of lending regulation and compliance experience across multiple states preferred
Excellent leadership, critical thinking and collaboration skills required
Professional verbal and written communication skills and the ability to communicate with discretion and understanding when confidentiality is needed
Must be analytical and possess ability to interpret and apply policies and regulations across a complex business
Must identify opportunities and take action to build trusting strategic internal and external relationships and networks
Must be approachable and collaborative, thrive in a fast-paced dynamic environment, and be comfortable quickly shifting priorities on short notice
Working knowledge of Microsoft Office products required

QC Manager Resume Examples & Samples

To approve specifications, sampling instructions, test methods and other Quality Control procedures
To check the maintenance of his/her department, premises and equipment
To ensure that the appropriate validations are done
To ensure that the required initial and continuing training of his department personnel is carried out and adapted according to need
Responsible for all testing and related documentation in the laboratory. Overall management of Micro personnel. In conjunction with other relevant departments, sets site policies on environmental and personnel monitoring
Generation and monitoring of schedules. Adjusts scheduling to maximize efficiencies and adequately support production and other relevant departments. Tracking/monitoring of sample cycle times in the laboratory
Ensures timely completion of Analytical Laboratory Investigation Reports and associated QARs. Issues trend reports in line with PQS requirements
Prepares recommendation reports regarding trends in the laboratory as required by QO Leader
Attends daily production meetings (or ensures representation by Snr. Laboratory personnel) in order to maintain workflow through the laboratory. Ensures that Senior Analysts are aware of changing Priorities
Interfaces with Materials Management in order to facilitate pre-determined shipping schedules
Prepares and administers Microbiology Laboratory goals and objectives. Assures timely implementation and completion
Conducts performance reviews for laboratory colleagues. In conjunction with colleagues, determines goals and objectives for them. Conducts quarterly meetings with colleagues to review progress and provide feedback
Responsible for resolving any personnel related issues in the laboratory
Prepares periodic reports to QO Leader regarding laboratory productivity to include recommendations for improvement
Maintains laboratory personnel holiday schedule
Identifies laboratory practices and procedures for further development /improvement. Generates plans for validation/transfer implementation. Assures timely completion
Evaluates internal and external audit reports and assists in the formulation appropriate corrective actions. Assures timely completion
Identifies training requirements for further development of laboratory colleagues.* Evaluates and approve Validation/Technical Services Protocols and reports for accuracy and compliance to requirements. Ensures that applicable laboratory personnel receive training in the testing requirements contained in protocols

BSA QC Manager Resume Examples & Samples

Responsible for interviewing and selection of QC staff, training and performance evaluations. Resolves employee issues and partners with Human Resources to handle disciplinary actions. Has oversight and involvement in department activities and establishes priorities
Ensures enterprise-wide timely completion and filing of Currency Transactions Reports, Suspicious Activity Reports and Monetary Instrument Logs
Conducts periodic reviews of daily work from all BSA groups by random sampling to test for accuracy, timeliness, completion and regulatory compliance. Responsible for reporting QC results to management. Provides recommendations and guidance to management and other departments for process improvements based on reviews and reporting results
Manages and develops the centralized QC of all BSA operational functions including KRI/KPI management reporting, review of regulatory reporting for suspicious activities including money laundering and terrorist financing
Primary contact and liaison with the OCC on all “BSA” quality control related matters
Provides feedback and training recommendations to all BSA staff to ensure quality regulatory reporting and responsive remediation of performance issues
Responsible for annual budget planning and ensuring budgetary goals are achieved
Effectively manages the department functions while meeting and adhering to corporate, legal and regulatory policies, guidelines and requirements. Work with Compliance and Legal to obtain updates. Maintains current knowledge of BSA, OFAC and USA PATRIOT Act and related regulations
Four year college degree or equivalent work experience is required. Individuals with a four year college degree in Business Administration, Management or other related fields would be preferred
5-7 years of previous BSA work experience in progressively responsible positions along with a minimum of two years of supervisory experience are required
Must be able to demonstrate thorough knowledge of the Bank Protection Act, Bank Secrecy Act, USA PATRIOT Act, International Money Laundering Abatement and Anti-Terrorist Financing Act, Federal Economic Sanctions Programs and OFAC regulations

QC Manager Resume Examples & Samples

Management of personnel within the Quality department. The Quality department is responsible for the following functions: Testing of manufactured product, testing of incoming materials as required, Microbiological testing of product and environment, Stability and Transportation testing
Management of Out of Specification results, Non-Conformances, Deviation and other relevant Quality Systems issues which relate to the QC department
Owner of QC related PA's (Preventive Actions) and CAPA's (Corrective Action, Preventive Action). Must ensure plans are executed on time and are effective
Key member of the Operations Management Team and Corporate Quality Team
Keep up to date of current Quality Standards and Regulations impacting the IVD industry
Leading complaint investigations through interaction with the subject matter experts
Maintain and enhance the current system of Tracking and Trending QC results and implement additional recording and analysis as appropriate
Ensuring that all customer specific quality requirements are compiled with following contract review
Input into Change Control and Document Control Systems
The Management of non-conformance and corrective and preventative action systems including the control of further processing and delivery of non-conforming product until any deficiencies or unsatisfactory conditions have been corrected
Key participant in design control
To drive an awareness of QC requirements throughout the organisation and to champion Quality and continuous improvement initiatives
To liaise with external parties on matters relating to the Quality Control systems within Trinity Biotech
Primary degree in a science or equivalent
3-5 years industrial experience, preferably in the IVD industry
Must have experience in project management of change programs
Ideally will have participated in FDA, HPRA and/or other regulatory authority audits

QC Manager Resume Examples & Samples

Lead & manage all Quality Control leaders & Analysts in QC Lab & Micro laboratory
Build QC team capability with the right technical mastery & leadership skills
Own QC budget & work on cost optimization/reduction via IWS tools
Lead the Lab Excellence Program
Lead the networking & benchmarking with regional resources for analytical methods troubleshooting and with other plants for re-application opportunities
Ensures all finished products produced are meeting the quality standards and specifications and the analytical work is following the current GLP requirements
Ensure QC lab is following all ISO, SASO & Saudi FDA requirements
Lead the Data Integrity Program Compliance in QC laboratories and systems
Lead the communication with all functions working with QC (planning, operation, QA, etc.)
Lead the audits in QC Lab and ensures all corrective and preventive actions are in place and effective
Support initiatives & overall business growth by ensuring quality of all our products across different categories
Review and approve all QC lab SOPs
Saudi citizen or have transferable Iqama
Has a BSc Degree in Chemistry or any other related field with minimum 5-7 years of experience
Working experience in FMCG, Food, or Pharmaceutical business
Has hands-on experience on QC lab instruments such as HPLC, GC, Atomic Absorption, Viscometer, IR, etc
Has good experience with method verification, lab instrument calibration and qualification
Demonstrate good problem solving skills through high technical mastery and long professional experience within analytical equipment and methods
Has good awareness about GMP & GLP practices
Has good experience about ISO, SASO and Saudi FDA requirements and audits
Has the ability to build technical capability in QC lab and resources at different levels. Successful experiences at coaching others
Has an effective written and verbal communications skills. Good English & Arabic commands
Has good knowledge about analytical data handling in compliance with FDA requirements such as software’s security and back-up system
The candidate should demonstrate managing multiple priorities and be able to work under pressure. Demonstrated ability to adhere to project time lines
Familiarity with many lab instruments’ agencies and services in Saudi Arabia is a plus
Adaptable and able to quickly establish rapport with others and work in diverse environment

QC Manager Resume Examples & Samples

Ensures the effective implementation of the quality program at the program/project level
Staffs assigned programs/projects with qualified quality personnel
Also ensures that the appropriate materials and equipment are supplied
Provides program/project specific indoctrination and training to the quality program
Monitors effectiveness to assess the need for additional or refresher trainings
Monitors quality assurance activities to determine conformance with corporate policy and procedures
Establishes and maintains client relationships at program/project levels to assure free communication of information and reasonable resolution of quality problems so that quality goals are attained with minimal rework and repair
Performs periodic audits and assessments of the effectiveness of the quality program on programs/projects of the business unit/business line
Provides periodic reports to the Director QA/QC, Quality Manager, and the program/project manager regarding the effectiveness of the quality program on programs/projects of the business unit/business line
Prepares program/project specific quality plans and procedures, under the direction of the Director Quality or Quality Manager, to ensure that the appropriate elements of the Quality Management Program Manual have been addressed
Prepares the quality scope definition for proposals as directed by the Director Quality or Quality Manager
Sets priorities for the team to ensure task completion; coordinates work activities with other supervisors
Typically does not perform the work being supervised
Interprets customer needs and assesses requirements
Works within budget to meet operational objectives set by manager
Resolves routine problems using defined processes and own experience
Coordinates resources to meet short-term objectives
Sets priorities for employees to meet deadlines
Manages performance of employees through task assignments, ongoing skill assessment and coaching
Typically has 0-3 years relevant experience

QC Manager Resume Examples & Samples

Independently plan, manage and execute assignments that support cGMP analytical commercialization activities
Author protocols and reports. Review external analytical data and methods as needed
Perform as analytical lead in commercial readiness meetings
First point of contact to troubleshoot a wide variety of analytical issues encountered with project activities. Coordinate shipment of necessary supplies and samples. Proactively communicate issues to key stakeholders to ensure a timely resolution and escalate as needed to ensure corporate timelines are met
Collaborate to develop and plan testing required for investigations and responses to regulatory agency queries
Proactively seek out senior collaborators to discuss potential solutions to problems. Ability to clearly present results of work, interpret data and draw conclusions
Work collaboratively with cross functional departments to manage project activities
Maintain current knowledge of relevant cGMP regulation, regulatory guidance’s, and internal SOP requirements for method transfer activities
Thorough understanding of the regulatory process and cGMP QC analytical environment
Minimum 5 years of relevant experience in late phase drug development or commercial product support
Demonstrated ability to apply advanced level of understanding to project goals and methods
Experience contributing to the development of project strategy
Work cross-functionally within organization to achieve common goals
Ability to recommend alternatives, research new methods and techniques and proactively seek out collaborators to discuss potential solutions to problems
Excellent written and verbal communication skills and experience interacting with people from a wide range of skill levels and experience
Ability to communicate complex scientific findings and recommendations in one-on-one discussions and departmental meetings
Excellent technical writing experience in a regulatory environment such as protocols, reports, and SOPs
Demonstrated ability to work as an independent, self-motivated, detail-oriented, result-driven and highly flexible team-player in a fast-paced working environment
Excellent attention to detail; excellent project management skills including the ability to manage ones project resource requirements (material, manpower, time, etc.), and ability to elevate relevant issues to project lead and line-management
Ability to work independently and as part of a team with internal and external clients, self ‑ motivation, adaptability, and a positive attitude
Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
BS/ MS degree in Pharmaceutical, Biological, or Chemistry discipline, and minimum of 10 years of relevant experience in late phase drug development or commercial product support

QC Manager Resume Examples & Samples

Perform assay development/validation for QC Chemistry group
Review new test procedures and assays
May evaluate and bring in new methodologies/techniques when needed
Facilitate assay transfer from R&D and to business partners
Organize analytical assay transfer internally and externally
Participate in technical troubleshooting and problem investigation
Review analytical development report, assay and process validation report and other technical documents for technical correctness and regulatory compliance
Participate in training programs for analysts
Performs personnel management functions including time sheet approvals, scheduling of vacations, employee development, and employee evaluations
Ability to work independently or on a team
Strong analytical and protein chemistry background
Ability to interpret and apply cGMPs, USP, regulatory requirements and industry best practices
Requires BS/BA or AAS in Life Sciences or related field plus 6+ years of experience working in a GMP lab including 2+ years of management experience
Level will be determined based on experience

QC Manager Resume Examples & Samples

Manage and coordinate studies and projects
Create and manage the QC schedule for all tasks and testing
Oversee and manage the calibration/PM schedule for QC
Act as the primary contact for the team interacting with various departments
Represent the functional area in meetings and compliance activities
Represent QC at daily/weekly manufacturing/facilities scheduling meetings
Represent QC at daily lot release MDI meetings
Participate in both internal and external audits
Coordinate daily scheduling and assignments
Review technical documents/protocols as required
Assist with interviewing and onboarding new hires
Act as change owner to assist with document change requests for CAPA/Periodic review
Run daily staff/MDI meetings
Actively supports the QC Management team
Completes Trackwise Laboratory Investigations/Deviations/CAPA/Change Controls
Ensures timely escalation of critical issues
Maintains positive relationships and networks effectively across sites and organizations
Participates in training more junior employees
Ensure all safety requirements are being met within the department including PPE and waste disposal
Facilitates operational excellence through continuous improvement initiatives
Master’s degree and 6 years of experience
Bachelor’s degree and 8 years of experience
6 years (you may choose to increase/decrease this number) of experience in the BioTech / Pharmaceutical Industry
3 years of experience in a supervisory or management role, leading teams or projects
Experience managing in a Quality Control environment for biopharmaceutical manufacturing operation
Experience managing scientific projects and personnel and presenting technical data
Experience with scientific technical writing including authoring and revising SOPs or technical reports
Experience with quality systems and related quality records such as deviations and CAPA
Strong leadership skills, driving accountability, compliance, development of laboratory associates and laboratory efficiency
Experience working with variety of HPLC detection technologies
Experience with Operational Excellence, Lean and/or Six Sigma a plus
Industrial Engineering Degree or Operational Optimization a plus
Advanced skill set in Excel a plus
Experience with laboratory information management systems (LIMS)

QC Manager Resume Examples & Samples

Works with facility line management to ensure program implementation and opportunities for improvement are communicated effectively along with assisting in the development of corrections to items identified as adverse to quality
Maintains tracking and trending of weld acceptance/rejection rates. This includes VT, MT, PT and UT/RT acceptance per welder and joint
Collaborates with facility management to ensure that work control processes that are consistent with code and customer requirements
Monitoring, measuring and analyzing work control processes and implementing improvements when needed
Meeting and improving on Quality Objectives
Providing adequate resources to complete assigned tasks
Providing adequate training to personnel to ensure that functions are performed correctly and in accordance with procedure
Maintain metrics and KPI’s to communicate the effectiveness of the Quality Program implementation
Ensure Qualifications/Certifications of personnel are maintained
Provide support and guidance to the organization regarding execution of the Quality Program, Procedures and project execution
Assist with reviews of codes, contracts and any other requirements for project execution
Development of ITP’s for projects along with reviews of JIS’s and other applicable project documents
Maintain effective communication with clients as applicable
Assist in the review of Quality and Technical requirements for development of purchase orders
Ensure adequacy of Quality Records through review and verification of implementation
Operate within a budget to meet organizational objectives
Facility Annual Management Review Meetings involvement
Submit weekly shop updates and monthly quality reports to Quality Director (KPIs, Areas of Concern, Future Initiatives, etc.)
Maintain Measuring and Test Equipment (M&TE) program including evaluation of out of tolerance conditions and tracking of required calibration
Maintenance of QC inspector certifications and ability to certify inspectors to applicable codes/standards
Tracking of NDE to ensure project requirements are met and components fabricated receive the proper inspection
In process inspections to ensure code and project requirements are met
Maintenance of facility certifications, such as ASME stamps, ISO certifications, etc
Performance evaluations of QC inspectors and NDE personnel as required to meet code/contract requirements
Able to multitask in environment with constantly shifting priorities
Certification in all NDE methods, Level II or above, preferred
Have working knowledge of codes and standards, minimum of 5 years preferred
Must have intermediate level knowledge of MS Excel, MS Word, MS Access
Must be able to work in a potentially hazardous, metal cutting environment consisting of hot pipe, loud noise, elevated temperatures and smoky atmosphere
Ability to read and write
Ability to effectively manage personnel, provide goals and set priorities. This also includes the ability to provide direction and resolution to problems and questions
Ability to collaborate and find resolutions to problems or disagreements
Ability to provide assessment and coaching of employees
Able to effectively communicate both verbally and in writing
Punctual and timely with regular work attendance
Possess proper work ethics, not limited to, positive attitude, willingness to learn
As per scope of work in shop, new or revised regulatory requirements (example: ASME B31.3, ASNT SNT-TC-1A, ISO 9001:2008/2015, NQA-1, Regulatory Guides, etc.)
Ability to interpret and evaluate inspection results
Maintain inspector certifications including potential ability to certify QC inspectors to applicable codes/standards

QC Manager Resume Examples & Samples

Bachelor's degree in a science discipline
Minimum 3 years' experience as QC Microbiology Supervisor or Manager
Minimum 5+ years of biopharmaceutical QC experience at a microbiologist level within pharma or medical devices
Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
Experience with Regulatory inspections desirable
Managerial/Supervisory experience with a proven record in a Supervisor/ Team Lead role
Strong background in microbiology and aseptic manufactured is required

QC Manager Resume Examples & Samples

Is a member of the Quality Leadership Team responsible for the day to day management activities of the QC laboratory function on both the Hull and Nottingham manufacturing sites
To standardise operations across both sites, to control and improve the analytical laboratories such that analysis is provided on time, Laboratory KPIs are met and that the laboratories remain in compliance with Good Laboratory Practice
Management of a team of QC analysts
Ensure adequate resources to enable customer service levels to be routinely delivered
Ensure compliance to international standards of GLP, Health safety and environmental, GMP
Ensure out of specification results are thoroughly investigated and batch failures are escalated quickly to avoid customer service issues
Ensure stability out of specification results are thoroughly investigated and are escalated within the Quality function to avoid Regulatory Compliance issues
Manage systems for laboratory equipment , procedures, documentation and training
Ensure NPD transfer and improvement projects are managed to project deadlines
Continually improves, modifies laboratory work practices and procedures to standardise best practice across both manufacturing sites which will compliment a flexible factory
Conducts internal and external quality audits as required
Approves formulation specifications for existing and new products
Responsible for people development within the QC laboratory teams
Proven management experience in a similar role in the pharmaceutical or an associated industry
Demonstrated people management skills
Good understanding of pharmaceutical document systems
Working knowledge of IT systems and their validation e.g. LIMS
Broad knowledge of pharmaceutical manufacturing processes including sterile products, solid and liquid dosage forms
Analytically capable, able to understand and resolve technical issues
Qualified Chemist – Degree, and member of professional body

QC Manager Resume Examples & Samples

A Bachelor's degree (B.S.) or equivalent experience in Microbiology or related life sciences field with 5+ years of relevant/ industry experience
5+ years of Management experience and/or training; or equivalent combination of education and experience
Proven knowledge of cGMP and USP guidelines as well as international regulations (i.e., International Committee on Harmonization (ICH) Q7) pertaining to Quality Control programs that support production of APIs, stability and drug product release
Ability to write and review protocols, reports, and procedure manuals
Ability to apply advanced mathematical concepts
Knowledge of and skill in using basic computer software and hardware applications, including Microsoft Word and Excel, as well as Stability Systems software
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 Manager Resume Examples & Samples

Bachelor degree or above with Chemistry related
Good at oral and writing both in Chinese and English
More than 8 years working experience in coating technical role
Coil coating technology and coating production process
Good analytical, problem solving, communication and interpersonal skills

QC Manager Resume Examples & Samples

Lead and develop the lab team to optimisetheir performance through coaching, performance development and training
Ensure daily and weekly lab work schedules are completed efficiently so that all test samples are analysedand released in a timely manner
Track Lab KPI's and lead regular lab team performance reviews to ensure continued improvement and focus on optimum performance to meet business and customer requirements
Proactively improve methods in line and ahead of industry best practice
Work closely with relevant site stakeholders including Operations, R&D, Supply Chain and Commercial staff, to problem-solve lab- related quality issues
Positive release of Powder, Cheese & Butter products
Ensure compliance to current laboratory quality system accreditation
Manage customer and Regulatory audits within the laboratories
Oversee the maintenance of the SAP QM system
Manage Laboratory procurement and budget
Change Control co-ordinatorfor product, packaging and labelling
Development projects including ISO 17025, LIMS, new customer requirements
It is the responsibility of all managers to manage health, safety and loss control in their area of responsibility in order to comply with the Risk Management Standard requirements
We must comply with statutory regulations and Group policy on health & safety
Minimum Degree in Food Science or equivalent, with relevant work experience in Microbiology
A minimum of 5 years work experience in leading and managing the performance of a team, preferably in a Food, Pharma, Dairy or Beverage Laboratory environment, is a strong advantage
Proven knowledge of quality systems and standards, Food microbiology methods, problem-solving, analytical lab validation and Lean
A working knowledge of Microsoft Office, SAP QM and LIMSis desirable

QC Manager Resume Examples & Samples

Moderate business travel will be expected for short durations (typically 2-3 days) to support, assess, and audit multiple plant sites and office locations
Establish and communicate project requirements so both direct report personnel and subcontractors can achieve the quality and or technical objectives
Participate in development, coordination, scheduling, quality, safety and progress review meetings. Identify personnel needs for projects and participate in the responsibility prerequisites, recruiting & vetting process for these needs
Provide direct and indirect support (coverage, planning, and evaluation) for major turnarounds
Monitor Corrective Action and Non-Conforming Item systems to ensure timely completion of corrective actions
Manages professional employees and/or supervisors; may manage business support, technical or production staff
Applies technical and/or managerial expertise to improve effectiveness and provide guidance to employees in the quality area
Maintain mechanical integrity program
Manages budget for Quality and allocates resources accordingly
Manages the performance of employees through goal setting, ongoing assessment and coaching
Must have 5+ years relevant experience in Quality and or Technical Services
One or more of the following certifications
Bachelor’s Degree in engineering, architecture, or construction management
American Welding Society certifications
American Petroleum Instituted certifications
American Society of Non-destructive Testing certifications
National Association of Coatings Engineers certifications
National Board endorsement
Trade apprentice graduate or craft certifications
Familiarity with following Materials of Construction: lead lined steel, glass lined steel, exotic alloys (e.g. - titanium, tantalum, high nickel alloys, etc.), ceramics, fiberglass-reinforced plastic (FRP), and plastic lined pipe and equipment
Familiarity and experience with pressure vessel design software and ASME VIII - 1 Code calculations

QC Manager Resume Examples & Samples

Manages day-to-day operations within the QC group in a fast-paced, dynamic work environment in compliance with current regulations and policies (FDA, OSHA, DEA, etc.)
Formulates and meets quality control objectives. Sets priorities with Operations and other managers to ensure quality and timelines are met to ensure material and products are tested, reviewed and approved within the accepted time frames.Interprets data and resolves technical issues
Reviews, authors, and edits documents, including deviations, change control requests, SOPs, test methods and related technical reports necessary for laboratory operations
Actively participates with cross functional teams and shares information, as appropriate, with direct reports.Oversees QC-related compliance activates, including investigation closure of any OOS/OOT/Atypical Results/CAPA events
Actively directs/leads/performs investigations and implements corrective and preventative action plans
Implements procedures and optimal infrastructure to ensure compliance with all regulatory agencies.Serves as the department representative on regulatory audits
Provides accurate and timely delivery of data and support regulatory filings
Performs assessments of current systems, to provide guidance for impartments to or development of streamlined GMP systems
Champions the continuous improvement process, defining process improvement projects
Coaches, mentors, leads, and manages employees.Ensures that training and other personal development programs are in place for succession planning and the development of subordinates.Ensures that performance opportunities are managed through the performance management system
Provides leadership for supervisors, analysts, and technicians to optimize productivity and quality of work.Provides effective planning for department operations to include required resources, and the maintenance and communication of cycle times
Demonstrates technical proficiency and self-assuredness in applying cGMP standards
Applies cGMP concepts in association with department specific responsibilities
Ensures all documentation produced is in compliance with cGMP standards
Responsible for contributing to audit readiness and for participating in quality audits with FDA, other Regulatory Agencies, and customers, as needed
Ensures work is in compliance with all state and federal regulations, including but not limited to GMP, DEA, FDA, etc
Responsible for departmental audit readiness and for participating in audits with internal Company groups, regulatory agencies, and customers
Ensures staff acts in accordance with EH&S policies, practices and procedures
Addresses staff issues accordingly if there are EH&S violations
Actively participates in root cause investigations on near misses and all incidents.Once identified, ensures corrective actions take place and compliance with Company policies and procedures, and all state and federal regulations occurs within the responsible department
Manages compliance with state and federal regulations, including but not limited to EPA, DEP, and OSHA, etc
Implements, applies and places emphasis on EH&S concepts with department specific responsibilities
Support the Company’s commitment for environmental health & safety by applying ISO 14001 and Sustainability 2025 principals into daily activities
Required, BS or MS in Chemistry or related field
10+ yeas in laboratory environment, preferably in API in GMP environment including 5+ years managing team
Extensive technical experience in analysis of small molecules, demonstrated knowledge of modern analytical techniques (HPLC, GC, KF, IR, NMR, DSC) and wet chemistry
Expertise and know-how with laboratory equipment in order to train staff and troubleshoot issues when needed
Proven ability to lead and coach, and motivate employees, clearly communicate job requirements and effectively manage performance of staff
Proven team player with well-developed interpersonal, organizational, mentoring and communication skills, including written documentation
Knowledge of SAP, LIMS and project managements’ experience desired
Interest in learning and applying new techniques
Ability to change priorities in response to company demands while continuing to deliver exceptional work quality
Well-developed supervisory, organizational, skills
Requires a B.S. or M.S. in Chemistry or closely related discipline with extensive experience in Analytical and Quality Control support of Active Pharmaceutical Ingredient (API)
PHYSICAL DEMANDS & WORK ENVIRONMENT
Must be able to lift at least 10 pounds. Must be able to work standing up or walking off and on for an 8 – 12 hour shift. Must be able to perform fine motor functions such as accurately weighing and transferring small amount of chemical compounds. Must be able to handle chemicals including potent ones in a safe manner, while donning appropriate personal protective equipment

QC Manager Resume Examples & Samples

Manage and support all QC personnel including hiring, firing, performance evaluations, training, and development to ensure a highly competent and engaged workforce
Implement a Quality Management System to ensure compliance with quality standards and/or contract specific documents that may include QC and QA inspection and testing programs, accredited lab facilities, and quality communication
Provide technical support for proposals, plants/materials, construction, sales, and estimating teams during pre-bid, construction, and post-construction phases of a project to ensure quality opportunities are optimized and all aspects of QMS are met
Conduct specification reviews, develop project QC/QA plans, generate material submittals, develop and review mix designs, review quality data and inspections, and manage QC/QA subcontractors to assure timely project success
Provide customer service to help provide customer satisfaction. This could include internal and external technical training on materials production and/or construction processes
Establish, maintain, and leverage relationships with local public agency technical staff, customers, and local inspection and testing companies
Support evaluation and implementation of new material technologies throughout the region, area, or large project well applicable
Prepare budgets, forecasts, project quality estimates, and manage all quality management finances to achieve positive cost center/project financial performance
Participate in and promote Granite’s safety procedures to promote a safe working environment including compliance with OSHA and MSHA rules and regulations
10 years technical/managerial experience or BS and 3 years experience
Technical knowledge of materials and construction concepts
Proficient with database operations and Microsoft Office Suite
Sound decision making ability with the experience to balance consensus against authority as appropriate
Excellent consultative and communication skills and ability to interface effectively with all levels of management
Training Skills

QC Manager / Welding Manager Resume Examples & Samples

The successful candidates must have experience working on large refinery construction projects, while any PMT or PMC experience or prior work with cokers would be preferred
You will be expected to work in a multidiscipline team environment where the overall success of the project is paramount. Amec Foster Wheeler is looking at a right-first-time approach and as such, we are looking for candidates who can rise to a challenge and are interested in being part of an innovative and driven team
Communicate the construction requirements to all contractors and staff, and coordinate the work of the contractors ensuring compliance and conformance with the safety plan, quality plan and client requirements
Ensure that all personnel on site are instructed and motivated with respect to HSES requirements and comply with the site regulations and permit-to-work procedures
Ensure all construction contractors’ supervision and labour adhere strictly to the project drawings, specifications, standards and procedures
Management and guidance of supervision to ensure site productivity and efficiency result in meeting contract targets
Ensure that the HSES and Quality policies are implemented and understood by all supervised staff and project contractors
In conjunction with Commissioning Manager ensure pre-commissioning requirements are undertaken in accordance with project specifications and procedures, and coordinated with ongoing construction activities
Support, promote and champion the Amec Foster Wheeler core values throughout the construction execution phase
Previous Amec Foster Wheeler experience
PMT or PMC experience
Recognized industry qualification
Conversant with relevant international standards and Codes or Practices
10 years' experience working on large refinery construction projects
Good experience in managing HSE and quality standards

QC Manager Resume Examples & Samples

Manage QC routine test to support batch disposition and supply
Managing people > 20 people
Managing all lab in QC, strive for lean and productivity within compliance and GxP corridors

TMF QC Manager Resume Examples & Samples

Single Point of Contact to the Therapeutic Areas (TA)/Clinical Trial Team for TMF related questions and serves as Subject Matter Expert on TMF Quality Control
Maintain documentation of appropriate oversight of all external partner’s work specific to document management within the TMF
Responsible for optimizing, maintaining, and rolling out TMF Quality Control training mechanisms
Translate trial information, processes and regulations into TMF documentation
Responsible for conducting specified quality controls on some essential clinical documents according to established processes
Track progress to key quality indicators (KQIs)s, and overall compliance to TMF processes and regulations
Oversight of TMF QC Specialists and monitor QC performed by the TMF QC specialists on assigned trials
Provide training/mentoring to the TMF QC Specialists on TMF processes, reconciliation/QC
Maintain documentation of appropriate oversight Of Vendor TMF Technical Quality Control Personnel specific to document management QC within the TMF
Single Point of Contact to the CTT for their assigned trials
Provide CTT with TMF QC reports and assist with TMF related questions (e.g. TMF Table Of Content)
Accountable for performing data analytics, identifying data issues / concerns, and facilitating the CTT in solving and implementing systemic solutions
Proactively “pull” information during the set-up, execution, and close-out phases from accountable CTT members
Participate in CTT meetings as needed, responsible for the training of CTTs on TMF and implementation of best practices within CTTs
Monitor the CTT compliance with TMF process within a trial in a timely manner
Accountable for generating and managing the TMF Filing plan and TMF QC Reports
Contact point to secure access to eTRAC system
Serve as Subject Matter Expert on TMF training materials, processes and tools (eg. Clinical Document Management system, user Manuals for eTRAC)
Participate and/or may lead some meetings related to TMF processes and trainings (eg TMF QC Compliance Review Meeting)
As a TMF QC Management & Oversight representative, may participate in global cross-functional business process performance or clinical development improvement initiatives
Timely, accurate and complete TMF Table Of Content according to trial timelines: Ready to Initiate Site (RIS); Close Out Visit (COV); End Of Trial (EoT)

QC Manager Resume Examples & Samples

Manages Quality Control department activities on all shifts
Works with other department heads to ensure the highest standard of quality for products as specified by Sanderson Farms’ quality assurance program
Cooperates with customer representatives to ensure that current specifications for products are being met
Works with USDA inspection, grading personnel, and production supervisors to assure that pertinent requirements are being met
Coordinates development and implementation of HACCP and SSOP programs to meet requirements of USDA regulations and requirements
Coordinates preparation and has primary responsibility for communication with USDA during EIAO Food Safety Assessments and other FSIS related activities
Coordinates with other departments in preparing for 1st, 2nd and 3rd party GMP and Animal Welfare Audits
Informs Corporate Quality Assurance Manager, Director, Technical Services and Division Manager on variances from standards of equipment, personnel, incoming materials and finished products as it relates to quality standards and USDA regulations
Trains and supervises activities of quality control personnel
Ensures quality of products received and produced by (but not limited to)

Assistant QC Manager Resume Examples & Samples

Perform QC testing to assess the strength, identity and purity of test samples and/or materials and also create/review the various documentation that are executed within the department. This position is 50% on the bench and 50% at the desk
Perform assigned sampling, physical, chemical tests and assay on raw materials, active pharmaceutical ingredients, in-process, finished and stability products, using various wet chemicals, physical and instrumental techniques (HPLC, GC, UV-Vis, IR, Particle Size Analyzer, KF Autotitrator, Bulk Density, and other routine QC instruments) as per as per USP monograph / In-house / any other Compendial monographs
Independently plan and make adequate inventory of test reagents and solutions to perform work, assure supplies are ordered as needed to perform assigned work
Independently plan and execute testing to meet established time lines. Perform complicated testing with supervisory direction
Record data and results as specified in documentation procedures. Document work clearly and perform tests accurately
Prepare and/or Review Test Procedures, SOPs, and Protocols as assigned
Perform maintenance/minor repairs and calibrations on laboratory instruments/equipment with supervisory direction/training
Perform troubleshooting and investigations under the direction of a supervisor/senior QC chemist
Comply with all regulatory/in-house requirements (may include but not limited to safety, housekeeping, laboratory chemical waste, cGMP, cGLP, documentation) when performing the assigned activity

QC Manager Resume Examples & Samples

Minimum 15 years experience in the role
Considerable experience of inspecting construction works to achieve effective construction execution
Experience in Industrial Installations
English language written and spoken is a must
Turkish language knowledge will be a plus

ESH & QC Manager Resume Examples & Samples

10 or more years of Program Operations Management for large complex organizations with multiple sites
Experience working in a scientific or research oriented environment (Laboratory, University, Medical Complex)
Bachelor’s degree in a scientific, engineering, or business field with more than twenty (20) years of related work experience in the management, operation, or administration of multi-million dollar research, development, demonstration, or commercial programs, projects, and facilities
4 or more years leadership/management experience managing teams with accountability to organizational leadership
Master’s or PhD in scientific, engineering Previous experience working for a National Lab
Demonstrated experience and ability setting priorities in a large complex institution while managing competing interests
Background in overseeing ESH for a National Lab. Experience in successfully managing to the labs QA plan

QC Manager Resume Examples & Samples

Responsible for the overall organization of the Quality Control lab while ensuring compliance with protocols, quality system, cGMP and other regulations
Review and approve data generated on Investigational Medicinal Products (IMPs) at QC release and during stability testing
Manage a QC team and prioritize tasks, this in close collaboration with CMC and GxP management
Coordinate and manage internal analytical method development
Set up validations of analytical methods
Support in solving analytical and stability related issues
Write, review and approve SOPs, stability and validation study plans and reports
As a member of the GxP management
Master of Science in Biochemistry/Biotechnology, Industrial or Bio-engineering, Pharmaceutical Sciences, or related discipline, or Bachelor with substantial experience
Relevant experience as supervisor or manager in a QC lab
Experience in the following domains is an asset: microbiology, ELISA, DNA/RNA technology
Experience in a cGMP environment/setting & Quality Assurance
Good communication, reporting and coordination skills
Excellent understanding of MS Office (Excel, Word, PowerPoint, Outlook)
Sense for initiative, accuracy and detail
Good communication and reporting skills
Fluent in English and Dutch, written and spoken
Dynamic, flexible and creative
Maintain a high degree of ethical standard and trustworthiness
Capable of fostering change and innovation in an organization
Ability to think and adapt to a rapidly changing environment and demands
Capable of high performance in independent work as well as in team setting

Cscs Project & QC Manager Resume Examples & Samples

Preparing project schedules and performing project tracking and reporting
Identifying when actual performance deviates from agreed tolerances and escalating issues as necessary
Ensuring that project team members are kept informed of progress, and stay aligned to the project goals
Ensuring that all required project documentation is completed and up-to-date
Coordinating deployment and communications plans
Supporting the development of materials and content for Certified Modules
Supporting the application of strategic project management initiatives
Coordinating project schedules by compiling tasks, costs, timescales and resource requirement lists from key project participants indicating start and completion dates, responsibilities and dependencies
Documenting scope changes and tracking approval by required parties to ensure benefit realisation
Tracking performance against budget and report any variances
Reporting project progress to all stakeholders and support the production of a well-structured communications plan
Performing progress tracking and reporting of issues, risks and mitigation plans and communicating progress
Effective translation /transcreation, print production and delivery of CSCS materials and updates
Management of CSCS activity in MyTalentWorld environment
Being an active CSCS Facilitator
University degree (desirable)
Business English

Post QC Manager Resume Examples & Samples

Promotes QC departmental growth and adherence to industry standards, ensures compliance with NAF QC Plan & NAF QC Servicing Plan
Oversees Post QC Department and processes. Includes hiring, staff training, required timeline management, meeting minimum monthly audit percentage standards, review of material findings, referral of suspected fraud to QA Manager and VP QC, follow up audits, engage with staff, operations and sales as needed to resolve issues/needs, follow up to corrective action, loan defect issues and action plan tracking with emphasis on curing issues/recommending self-reporting. Ensure remediation or corrective action to material findings and if necessary further review to resolve disputes, possible invalid vendor findings
Escalate trends, fraud and material audit findings to management
Finalize Post QC (origination & Servicing), Delinquency Audit and Vendor Oversight Reporting with monthly executive summary
Monthly Post QC meetings with Staff and Post QC Vendors
Maintain knowledge of NAF QC Plan, agency QC guidelines, underwriting guidelines, AUS (DU, LP and Manual) requirements, NAF overlays, NAF policy and procedures
Oversight of EPD/Delinquency Post QC audits. Review of timely completion, required reverifications, findings, corrective action and material findings. Monthly reporting and distribution of reports, trends, feedback, corrective action and resolutions, self-reporting
Monitoring of Material findings to ensure corrective action and either mitigation of the issue or agency self-reporting as applicable per QC Plan
Provide support as needed to operations to resolve material deficiencies and find solutions to mitigate such findings with agencies/investors
Oversee Agency QC file and Deficiency requests
Oversee and ensure monthly audit of cancelled/denied loans are conducted as per QC Plan with monthly feedback of results
Ensure post QC minimum vendor oversight audits are conducted with feedback to vendor and Sr. Management as applicable
QC vendor regular review of policy/procedures and audit standards along with annual onsite review to ensure agency and NAF standards are adhered to. Recommendation of NAF nuances to VP QC
Attendance of quality control industry conferences, maintaining industry knowledge of updates relates to QC, underwriting and compliance
Maintain critical records and documents related to quality control as per NAF QC Plan
Establishing goals and objectives with QC Staff
Provide ongoing analysis of streamlined processes along with automations
Ability to analyze risk as it relates to investment quality loans
Ability to detect and prevent Fraud/misrepresentation
Knowledge of agency/regulatory/investor quality control guidelines and requirements
Demonstrate advanced product and underwriting knowledge of FHA, VA, Conventional and all other loan programs offered by NAF
Working knowledge of federal and state guidelines, rules and regulations such as RESPA, TILA, HMDA, etc
Ability to maintain a high level of professionalism, customer service, and communication with all parties involved in the quality assurance/quality control loan cycle
Extensive knowledge of DU, LP and manual underwriting of loans
Ability to manage the review audit documentation, perform analysis, validate and document potential risk to determine course of appropriate corrective action and/or make recommendations of such action
Ability to detect possible misrepresentation and/or fraud
Excellent written and oral communication skills with the ability to rate and categorize risk ratings in a clear and concise manner
Working in a paperless environment and LOS
High school diploma or general education degree (GED); Ten years' experience in this field of work is preferred
DE and/or VA underwriting designations or Fraud Examiner Certification (CFE) preferred but not required

QC Manager Resume Examples & Samples

Facilitate and assure effective and efficient collaboration and sharing of resources among Areas, Regions, and Large Projects in operations responsible for management,
Provide technical and engineering support for proposals, plants/materials, construction, sales, and estimating teams during pre-bid, construction, and post-construction phases of a project to ensure quality opportunities are optimized and all aspects of QMS are met
Conduct specification reviews, develop project QC/QA plans, generate material submittals, develop and review and stamp mix designs, review quality data and inspections, and manage QC/QA subcontractors to assure timely project success
Perform professional engineering services for operations (including stamping/sealing) in accordance with the Granite PE Stamping Policy and applicable State Statutes, if licensed
Participate in and promote Granite’s safety procedures to promote a safe working environment including compliance with OSHA and MSHA rules and regulations.#LI-ML1
10+ years technical/managerial experience

QC Manager Resume Examples & Samples

Provides technical and process knowledge for water treatment/waste water, product batching, product testing, package testing and supplier capability
Demonstrates a working knowledge of production equipment (processing and packaging equipment) and its' related impact on overall quality
Maintains inventories of ingredients used for production
Maintains up-to-date knowledge of process improvements and technical developments Builds people capability through effective employee relations, hiring, training, and communication for both management and front-line hourly personnel
Ensures compliance with all Health & Safety regulations
Ensures plant is in compliance with all Food Safety Regulations internal and external
A minimum of 2 years of supervisory experience
Previous experience within the Quality Control department of a high speed manufacturing environment, preferably consumer packaged goods
Ability to work a flexible schedule including evenings and/or weekends

QC Manager Resume Examples & Samples

Ability to be mobile and work in a diverse, high-pressure, and fast-paced environment
Both spoken and written knowledge of the English language
Good employee relation skills
Minimum 3 years of experience in a related field
Training certificates, licenses, and certifications as necessary

QC Manager Resume Examples & Samples

Responsible for all Quality Management Systems: ISO 9001 and AS9100 (the Aerospace Quality Standard)
Run department efficiently by scheduling and managing overtime, ensuring production coverage
Execute and maintain the Quality Module within SAP, business enterprise software
Interface with production, technical and customer service
Responsible for all material returns and determining the disposition
Responsible for customer complaints, including resolution and corrective action
Responsible for managing all non-conforming material
Prepare monthly site Quality Report
Provide related quality information to the monthly Manufacturing Performance call, these include Statistical Quality Control data for selected products and raw materials
Commitment to maintaining high safety and housekeeping standards in the laboratories
A minimum of a Bachelor’s Degree in Chemistry or related science with 3+ years related experience
Experience in supervision and developing direct reports
Knowledge of ISO 9001 and Quality standards required. Previous experience in a facility with AS 9100 certification is a plus
Experience with customers and participation in quality audits of suppliers and customers
Internal auditing experience and/or certification
Experience in an aerospace or aviation manufacturing environment with knowledge of managing customer specifications and process control documents (PCD)
Thorough understanding of statistics and statistical process/quality control (SPC/SQC) techniques; process capability studies (Cp and CpK); test repeatability/reproducibility studies, analytical round-robins, etc
Knowledge of SAP knowledge or similar business enterprise software
Strong leadership, organizational and problem solving skills
Must have a level of proficiency with internet, email, and Microsoft Office Suite

QC Manager Resume Examples & Samples

Management of daily/weekly/monthly and longer term activities of staff and operational oversight of group, data review, scheduling, oversight of group training
20-40%
GMP documentation related activities (ex. SOP revisions, quality systems related events, method related project documents as required), oversight of group metrics
Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support
Typically requires a minimum of 10+ years of related experience. (Science related degree is preferred)
Relevant supervisory experience preferred
Excellent communication, interpersonal and organizational skills
Proactive at keeping current with literature and latest technologies
Ability to prioritize work and multitask
Conducts work in compliance with cGMPs, safety and regulatory requirements

Market Access QC Manager Resume Examples & Samples

Manages the Actelion Vault quality document system and Market Access workflows including but not limited to SP audits, non-audit deviations, AE compliance notifications, SP training records, and SP and Payer contract archive
Executes the annual audits that are managed by Market Access including auditor training, sending audit notification letters, compiling data for the auditors, scheduling audit prep and close-out meetings, facilitating weekly audit calls with the working team, following-up on all notification and pending action items, preparing trend reporting and conducting quarterly management audit reviews as outlined in the SP and WD Audits SOP and ensuring all of the necessary documents are complete, signed and archived for future inspection
Manages the non-audit deviation process to ensure timely documentation and resolution of deviations occurring at external vendors including the SPs/WDs, pathways hub or REMS data aggregator; Conducts quarterly trend analysis as outlined in Deviation Management SOP
Submits Technical Product Complaints to QUATRO, coordinates communication with the SPs/WDs and Drug Safety and gathers missing information so that Global Technical Operations can properly evaluate and resolve cases
Serves as the Quality Champion for Market Access including drafting, uploading and implementing SOPs, monitoring compliance with applicable SOPs, identifying and addressing gaps in current Market Access procedures, making updates to procedures as appropriate, maintaining proper records for inspection readiness, and supporting Market Access during audits
Coordinates CAPA development and implementation for audit findings assigned to Market Access
Partners with Market Access Trainer to implement SOPs, improve compliance and address gaps
Supports the creation of training materials for SPs/WDs, Pathways hub, SP managers and therapy access managers to improve quality and compliance
High school diploma/GED with 12 years relevant experience of which eight years are in biopharmaceutical industry; equivalent combination of bachelor’s or advanced degree and less experience may be considered

QC Manager Resume Examples & Samples

Develops the staffing plan for the quality control organisation in support of cost and schedule planning activities
Develops, in conjunction with UK Tier 2 contractors, the project’s multi-discipline quality control program and procedures
Develops, in conjunction with UK Tier 2 contractors, the construction quality control inspection program
Develops, in conjunction with the UK Tier 2 contractors, the quality control certification and training programs
Supports development of the construction execution strategy and plan to ensure compliance with the contract, governing industry and government quality standards, project specifications and the established quality control criteria
Participates in design and constructability reviews, as appropriate
Develops the staffing plan for the quality control organization for approval by the Site Manager and prepares employee requisitions
Directs the activities of a multi-disciplined construction quality control organization overseeing quality control and inspection activities of assigned quality control engineering staff
Develops, administers and implements a project’s multi-discipline quality control program and procedures
Coordinates the activities of quality control engineers and interfaces with other construction departments to ensure that construction operations are in compliance with the contract, governing industry and government quality standards, project specifications and the established quality control criteria
Participates in major contract discussions and negotiations relating to quality control activities
Provides guidance and assistance to various levels of the project organization on construction quality control programs
Responsible for development and administration of the construction quality control inspection program
Reviews subcontractor documents for compliance to project quality control requirements
Administers surveillance inspection program over subcontractors to ensure conformity to project specifications and standards
Administers employee development program
Administers quality control certification and training programs
Performs employee reviews of the construction quality control staff
Oversees the performance of inspection and ensures acceptance is documented of construction activities and installations
Develops and administers the project nonconforming and deficient items program
Knowledge of NPP Construction preferred
General construction planning experience
Knowledge of Bechtel’s “Zero Accidents” safety program preferred
Knowledge of current Bechtel (preferred), project and industry quality standards
Knowledge of critical phases of construction quality control engineering relating to multi-discipline construction activities
Knowledge of construction activities relating to civil/structural, mechanical, electrical, soils, welding, piping, instrumentation and documentation
Demonstrated ability to develop detailed quality control program based on the contract and Bechtel (preferred), project and industry quality standards
Demonstrated experience in quality control activities for nuclear power and/or non-reactor nuclear facility EPC projects
Demonstrated leadership in a team-based environment
Knowledge of international, federal, state and local government quality compliance standards
Computer literate in word processing, spreadsheet and technical database applications in accordance with current Bechtel Standard Application Program (BSAP) standards (preferred)
Capable of obtaining quality control certification in primary discipline, as defined in the quality control program
Knowledge of Nuclear Work Process Procedures (NWPPs) preferred
A recognized degree in an engineering or scientific discipline, OR
Specialized courses in construction management, AND/OR
Work experience leading to a thorough understanding of the knowledge described above

QC Manager Resume Examples & Samples

Lead the salaried Quality professionals to ensure effective application of quality mgmt techniques. Deliver effective change leadership while driving business changes and minimizing people impact
Communicate/collaborate cross-functionally to assist team to solve operational issues
Builds people capability through effective employee relations/hiring/training/communication for front-line hourly and salaried personnel
Motivate team members to achieve plan goals. Identify and lead efforts of product/process quality and cost management opportunities to achieve productivity gains
Provide leadership to the plant QM Pillar through the TPM journey
Lead/develop action plans with production, engineering and division Quality Assurance to improve the product specifications/analytical procedures/sampling programs/ensure that they are appropriate and meet system capability and key consumer requirements
Provide visionary insight for future business improvements. Serve as a key statistical resource. Verify product and process improvement through the implementation and analysis of statistically designed experiments and capability studies
Lead food safety and compliance audits, including FSSC 22000, AIB, QAS. Ensure all sanitation is complete/properly meets quality standards
Design/implement programs to monitor calibration and accuracy of all analytical procedures and equipment in the plant
Ensure compliance to the OSHA chemical hygiene plan and proper laboratory safety practices by involving all employees in an effective safety program; provide training, periodic review of hazards, and timely correction of hazardous situations
Manage the interpretation of in-process and analytical data to make quality evaluations, recommend actions for improvement, and assure resolution. Challenge results and drive improvement. Coach others in the interpretation of results
Lead risk assessment analysis throughout the plant. Manage issues with non-conforming product to assure proper control, minimize loses, and provide analysis to drive the elimination of future occurrences. Provide training in area of food science/regulatory requirements/quality measurement systems to appropriate personnel
Administer policies and procedures. Regular and predictable attendance at the work site
This role requires regular presence on the plant floor/lifting up to 40 lbs. occasionally/occasional work in poor weather conditions, including heat, cold, rain, or snow/operate forklift and manufacturing equipment occasionally/off-shift and weekend work/require some travel (less than 5%)
Bachelor's degree or equivalent experience required. Preferably in engineering, business, operations management, or similar field. Lean Six Sigma Experience preferred, demonstrated by successful completion of a major improvement project
Min of 5 yrs exp in Food/Beverage Industry preferred
Clear understanding and working knowledge of process/compliance quality systems/TPM Processes
Strong organizational/interpersonal/presentation skills. Knowledge of regulatory requirements/AIB standards. Ability to motivate/lead/work with teams
Proficient in Microsoft Suite applications. Ability to give/receive constructive feedback and to lead a team-based approach to decision making
Demonstrated ability to work in a results-oriented/challenging environment. Strong leadership skills with ability to get results through mentoring others. Effective coaching/facilitation/presentation/team building skills. Must be authorized to work in US

QC Manager Resume Examples & Samples

Responsible for the overall management of two separate Quality Control laboratories supporting the manufacture of API and finished capsule product. The API QC laboratory operates on 24/7 shift
Ensure that QC laboratories are set up and operate in compliance with current Good Laboratory Practice / Good Manufacturing Practice at all times. Implement and maintain standards of GLP and analytical practice consistent with current regulatory expectations and Global Takeda standards
Develop and maintain excellent communication and collaboration between QC and other work areas
Supervise QC Executives including training, recruitment, motivation, discipline and performance appraisal
Ensure that testing schedules are achieved and manage laboratory resources (instruments and personnel) to provide a comprehensive analytical service for testing of the following: raw materials, packaging components, in-process samples, intermediates, APIs, finished drug products, validation samples, stability, purified water and cleaning samples
Lead and participate in the Technical Transfer / Validation of new and existing processes
Manage the investigation into any non-conformance, instrument malfunction, accident or other abnormal occurrence. Ensure that any Out of Specification (OOS) or Out of Trend (OOT) analytical results are managed as per SOP
Manage an effective QC documentation system. The QC Manager will prepare, review and approve documents as required
Prepare for, and support, internal and external audits (HPRA, FDA, corporate, customer)
Actively lead and support major projects, quality initiatives and continuous improvement programmes within the Quality department and in other functional areas
Implement and maintain standards of safety to ensure a safe working laboratory. Ensure that the laboratory is kept clean, tidy and safe at all times
Generate, implement and control of QC annual budget for consumables, capital and headcount
As required, act as designee for the Site Quality Head in their absence
Participate as required in global project teams relating to QC and wider quality activities
Participate fully in any cross functional training initiatives
Drive and promote the corporate values of Takeda-ism within the workplace
Actively foster, in cooperation with other staff, an ethos and culture of safety awareness where safety is accepted as an integral part of the overall business
Ensure that Accident Reports / Near Miss Forms are completed in a timely manner after an event
Ensure timely completion of all SOP, reading, training and assessment
Other duties as required and directed by the Site Quality Head or other Officer appointed by the Board of Directors
More than 10 years’ experience in the pharmaceutical industry and minimum of 3 years QC Laboratory Management experience
Experience in budgetary control and audit preparation
Thorough knowledge of GMP and current FDA & EMEA regulations for API and solid oral dosage pharmaceuticals
Previous experience in managing the performance of individual team members and that of the overall team
Knowledge and experience of Lean Laboratories is preferable
Previous experience in setting up a new QC laboratory is desirable
Excellent organisational, communication, interpersonal and report writing skills
Strong analytical knowledge, particularly in HPLC and GC
Demonstrable experience managing, motivating and leading a team
LI-PD2-EUR

QC Manager Resume Examples & Samples

Responsible for managing and coordinating the activities of the Quality Control associates engaged in sorting, testing, and inspecting products and raw materials in order to ensure compliance with quality standards
At this level the role has increased responsibility including participating in interdepartmental meetings, regulatory assessments and working with diverse teams, etc
Project planning, working with global stakeholders for stability transfers, new technology transfers
Mentors, trains and supervises the quality control team. Evaluates performance and provides opportunities for growth
Works on department objectives and metrics
Implements changes in processes required to maintain or improve compliance with quality standards of existing products and to establish initial and continuing compliance with quality standards for new and/or redesigned products
Participates in Regulatory assessments and is able to implement changes in regulations
Ensures timely handling of OOS/OOT; stakeholder communication and leads scientific investigations
Participates in regulatory and internal audits to present laboratory data. Also responsible to ensure that prompt and appropriate actions and associated corrections are taken
Communicates metrics and systems used to measure and guide improvements to product and system quality and customer satisfaction to quality control staff
Provides input to quality control reports, requirements and other information in response to requests for proposals, quotes and other business opportunities
Provides input to budget planning process. Utilizes cost control initiatives to reduce expenses. Makes recommendations to management regarding ways to improve lab processes and increase product quality and delivery while reducing costs
Scientific acumen

Project QC Manager Resume Examples & Samples

Establishes implements and maintains site quality program. Coordinates with engineers, suppliers, subcontractors, regulatory representatives and field to ensure that work is done correctly
Assures work on-site meets applicable codes and specifications
Develops and administers site specific Quality Programs
Surveillance/Audits of site Contractor Quality Control Programs
Establishes inspection plan and track inspections/actions identified
Approves site testing such as soils testing, concrete placement and grout breaks, hydro tests, and NDE testing and verify tests are properly documented
Assists in the coordination of punchlist walkdowns/inspections; establishes and manages the punchlist
Collating Quality Control documentation for final handover to Owner
Degree in Engineering/Construction
10+ years of site quality, construction supervision experience of EPCm/EPC construction
Experienced as overall Site QC Manager

Senior Site QC Manager Resume Examples & Samples

Develop and administer site specific Quality Programs
Responsible in all aspects of welder qualification on-site testing
Responsible for issuance, control and coordination of Post Weld Heat Treatment (PWHT) and Non Destructive Examination (NDE) contacts
Reviews and controls documentation for the certification of construction equipment and testing equipment
Reviews turnover packages prior to handoff to Startup
Collating QC documentation for final handover to Owner
Interfaces with clients and government officials
Develops and implements quality programs that assist projects and division to meet company and division quality goals and expectations
May act as Quality Consultant for internal and external clients
May act as temporary project fill-in for lower level quality professionals
Provides supervision, training, development, and performance management of direct reports
Acts as mentor to other quality professionals
Implements Safety, Quality, Ethical Stds., Lessons Learned, and adheres to Performance Management programs in accordance with Division Policies, Standards, and Guidelines
Supervises work of others. Responsible for hiring, discipline, and pay administration of their subordinates including other site QC managers, site QC inspectors, and other site QC representatives (technicians, specialists)

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