QC Manager Job Description
QC Manager Duties & Responsibilities
To write an effective QC manager job description, begin by listing detailed duties, responsibilities and expectations. We have included QC manager job description templates that you can modify and use.
Sample responsibilities for this position include:
QC Manager Qualifications
Qualifications for a job description may include education, certification, and experience.
Licensing or Certifications for QC Manager
List any licenses or certifications required by the position: CWI, AWS, ISO, 9001, HAZWOPER, ISO9001, NDE, ACI, API, OHSAS
Education for QC Manager
Typically a job would require a certain level of education.
Employers hiring for the QC manager job most commonly would prefer for their future employee to have a relevant degree such as Bachelor's and Master's Degree in Chemistry, Engineering, Science, Microbiology, Technical, Biology, Education, Biochemistry, Business, Management
Skills for QC Manager
Desired skills for QC manager include:
Desired experience for QC manager includes:
QC Manager Examples
QC Manager Job Description
- Responsible for all testing and related documentation in the laboratory
- Ensures timely completion of Analytical Laboratory Investigation Reports and associated QARs
- Attends daily production meetings (or ensures representation by Snr
- Conducts performance reviews for laboratory colleagues
- Identifies laboratory practices and procedures for further development /improvement
- Evaluates internal and external audit reports and assists in the formulation appropriate corrective actions
- Organise and drive the analysis and risk management system (HACCP, traceability )
- Management of personnel within the Quality department
- Owner of QC related PA's (Preventive Actions) and CAPA's (Corrective Action, Preventive Action)
- Maintain regulatory compliance through the creation and maintenance of programs for, training, SOPs and validation
- In depth understanding of Software Testing methods
- 5+ years of vendor management experience, preferably with both nearshore and offshore experience
- Experience negotiating, writing and enacting contracts (from RFP to signature)
- Very familiar with the localization vendor landscape
- Minimum education is a diploma if coupled with appropriate relevant experience
- 5-7 years' experience in a laboratory, 2 of which should be at Senior Analyst or Supervisory level
QC Manager Job Description
- The number and severity of GMP issues identified during internal and external audits related to IH laboratory functions
- Must be familiar with GMP's and Quality System Regulations (QS Regs) and practical judgment in the interpretation and application of regulations and standards specific to the Quality Control laboratory or blood bank laboratory
- Lead the laboratory personnel responsible for testing and disposition of raw materials, packaging components, in process samples, drug substance and drug product
- Develop and lead the QC team in areas of expertise, use of operational excellence tools, and high performance team behaviours
- Provide technical expertise and leadership to the QC group ensuring samples are tested under cGMP within specified timelines
- Oversee the introduction of new products and methods into the laboratory
- First point of contact to troubleshoot a wide variety of analytical issues encountered with project activities
- Proactively seek out senior collaborators to discuss potential solutions to problems
- Manage the activities of the Daily Operations Section through the Associate Manager and Supervisors assigned to that Section
- Ensures appropriate compliance with Stability policies, regulations, procedures and protocols
- Computer literacy (including MS Word/Excel/power point/MS Project)
- Testing within analytical & chemistry laboratories
- International standards such as IEC, ASTM
- Has the ability to build technical capability in QC lab and resources at different levels
- The candidate should demonstrate managing multiple priorities and be able to work under pressure
- Commitment to quality and continuous improvement in all areas
QC Manager Job Description
- Reviews and approves Stability Study Protocols
- Reviews data, trending and reports exchanged between the Daily Operations and Metrics and Data Management groups for compliance and eventual inclusion in regulatory submissions
- Oversees purchase of and identifies new equipment required for conducting stability studies and ensures that all stability equipment operates within appropriate parameters
- Maintains a trending database
- Reviews all test results and data for regulatory compliance
- Schedules/assigns project duties to Stability Coordinators and ensures work is complete for each stability time point and condition
- Ensures QC leadership is kept informed as needed
- Attends meetings and keeps informed of manufacturing priorities
- Leads cross functional teams and manages the deliverables for the assigned projects
- Develop and maintain forecasting tools for QC testing and projects
- Ability to work safely and encourage safe practices
- Flexible in solving problems
- Builds credibility in your effective communication style within team and cross functionally
- Tailor message to audience to motivate and encourage
- Demonstrated expertise with analytical methods used to assess pharmaceuticals and biologics, especially HPLC and other analytical tools
- Requires BS/BA in Biochemistry, Chemistry, Biology or related field with 8+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries, including 3 years of management experience
QC Manager Job Description
- Proactively identifies issues and provides general guidance to resolve QC operational issues and works with laboratory management to develop solutions to meet productivity/quality objectives
- Monitor and coordinate the QC activities required for submission of license applications, INDs, and other regulatory documents to government agencies
- Monitor the departmental performance for NOE/EOE/DNF/CAPA/WF
- Regularly interacts with Sr
- Serve as a primary point of contact among functional areas for QC-related issues
- Manages the bio-analytical and cell-culture cGMP clinical testing laboratory for drug potency analyses by in-vitro cell-based bioassays and ELISA-based binding assays
- Works closely with the bioassay development group laying out the requirements and ensuring that the bioassays are ready for clinical / commercial routine resting environment
- Work with relevant SMEs laboratory management to determine best practices for bioassay and binding assay design and execution
- Coordinate activities with method development team, QC Commercial Testing Manager and Assay validation manager, ensuring consistent timelines and priorities for all method transfers and validation-readiness
- Receive assays from bioassay development team and implement them in the QC Clinical laboratory
- BA/BS in chemistry, biology or related field with 5+ years of relevant experience, preferably in the pharmaceutical or biotechnology industries
- Requires excellent written, verbal and interpersonal communication skills and the ability to effectively interact with all levels both within and outside the company
- Support bioassay method transfer activities into QC, within QC, and from QC to external partners
- Support reviewing, drafting and revisions of bioassay related SOPs in association with development group
- Support and approve investigations into atypical and OOS test results obtained during product testing
- Represents QC at meetings to understand manufacturing and clinical development needs and priorities, and provide analytical information and expertise
QC Manager Job Description
- Coordinates with members of Analytical Sciences, Manufacturing, Stability, and Business Ops to provide analytical support
- Manages associates, testing schedules, distributes work load, and monitors progress
- Maintains Project Management of Method transfers
- Maintains tracking and trending of weld acceptance/rejection rates
- Submit weekly shop updates and monthly quality reports to Quality Director (KPIs, Areas of Concern, Future Initiatives)
- Manage quality control database by updating inspection requirements, collecting data, generating reports, in accordance with contract requirements
- Supervise product testing
- Reviews test reports and perform data review as needed
- Responsible for all Safety and cGMP activities of associates working in Quality Control including Chemistry, Sample Management, Biochemistry, and Microbiology
- In conjunction with the Stability Coordinators and Supervisors, uses extensive training and experience to work with product teams to identify and plan stability studies to support clinical and regulatory requirements
- Requires a minimum of BS/BA in cell biology, biochemistry, or related field and 7+ years of relevant experience in a biotech or pharmaceutical laboratory
- Strong technical background, analytical and writing skills, and hands-on experience in a biology laboratory are must
- Bachelors or Master’s Degree in any Life Sciences with relevant laboratory coursework and 10+ years of relevant experience, 5+ years management experience preferred
- Previous industry experience in a regulated environment required
- Ability to effectively manage personnel, provide goals and set priorities
- Bachelor's degree required with a concentration in Business or Science (preferred)