Job Title: Manager, Quality Control
Department: Quality Control - Analytical
GENERAL DESCRIPTION:
- QC Manger is responsible for overseeing a team of QC Analysts and is also responsible for maintaining the QC Laboratory in a state of cGMP compliance.
DUTIES AND 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
EDUCATION AND EXPERIENCE:
- 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.
DESIRED KEY COMPETENCIES:
- 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.
EOE/MFDV