Manager, Quality Control
About The Position
The QC Manager is responsible for overseeing a team of QC Analysts and maintaining the QC Laboratory in a state of cGMP compliance. This role involves training, coaching, and developing QC staff, as well as developing, revising, and reviewing SOPs, qualification/validation protocols, and reports. The manager will also be responsible for writing deviations, CAPAs, and owning change controls, as well as reviewing and providing guidance for deviations/CAPAs generated by QC Analysts. A key part of the role includes reviewing invalid assays, leading invalid assay investigations, and participating in OOS investigations. The manager ensures all analytical data generated by the QC lab is initiated on time and completed within established turnaround times (TATs). This includes performing reviews of QC documentation such as equipment logbooks, solution preparation records, cell line records, and TRFs, and ensuring test results are entered into appropriate reports. The role also involves tracking and trending reference standards, assay controls, and critical reagents, as well as tracking equipment cleaning, preventative maintenance, and calibration schedules. Reviewing equipment IOQs and re-qualifications, and driving continuous improvements in QC processes and procedures are also key responsibilities. Other duties as needed will be performed.
Requirements
- BS degree in the Biological Sciences, Bioengineering, or Chemistry.
- 7+ years of experience performing QC activities in the pharmaceutical and biotech industry under GMP guidelines, with demonstrated expertise in multiple disciplines and assays.
- 2+ years of supervisory experience.
- Advanced experience with QC testing in pharmaceutical or biopharmaceutical laboratories
- Familiarity with analytical testing procedures: qPCR, HPLC, ELISA, Cell-based Assays, etc.
Nice To Haves
- Demonstrated ability to manage a team and work independently on projects, and review project data and provide summary analysis reports based upon the data
- Ability to provide support for regulatory and client audits, as well as interact with clients.
- Ability to effectively negotiate and build collaboration amongst individuals.
- Ability to be self-motivated, proactive, accountable, and flexible
- Demonstrate the ability to develop, coach and mentor key employees.
- Excellent interpersonal, verbal, and written communication skills are essential in this collaborative work environment.
- High attention to detail, highly organized, and excellent documentation skills
- Strong scientific, analytical, and problem-solving skills as well as sound judgment, to identify problems and leads efforts to resolve them
- Comfortable in a fast-paced small company environment with minimal direction and able to adjust workload based on upon changing priorities.
Responsibilities
- Training, coaching, and development of QC staff
- Develop, revise, and review SOPs, qualification/validation protocols and reports.
- Write deviations, CAPA’s and own change controls.
- Review/Provide guidance for deviations/CAPA’s generated by QC Analysts
- Responsible for reviewing invalid assays and lead invalid assay investigations
- Participating in OOS investigations
- Responsible for ensuring all analytical data generated by QC lab to be initiated on time and completed within established TAT’s.
- Perform review of QC documentation (equipment logbooks, sol’n prep record, cell line records, TRF’s, etc)
- Ensure test results are entered into the appropriate reports
- Track/Trend Ref. Std, Assay Control and Critical Reagents
- Track equipment cleaning/PM/Calibration schedules
- Review equipment IOQ’s and Re-Qualifications
- QC Process/Procedure continuous improvements
- Perform other duties as needed
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What This Job Offers
Job Type
Full-time
Career Level
Manager
