Quality Assurance Manager
6 days ago
We are seeking a highly skilled and experienced Quality Control Supervisor to join our team at Cambrex. As a key member of our laboratory team, you will be responsible for providing supervisory oversight, laboratory testing support, and technical leadership for laboratory staff.
Key Responsibilities- Coordinate daily prioritization of laboratory testing, including staff and equipment utilization.
- Maintain laboratory instrumentation, including equipment qualification, and preventative maintenance programs.
- Support training and troubleshooting efforts for staff.
- Review completed laboratory testing to support the timely release of data, reports, and material.
- Coordinate and oversee the status of offsite sample testing.
- Maintain and manage cGMP and general lab systems at defined levels of compliance.
- Draft and review various documents in support of laboratory efforts and production campaigns.
- Maintain laboratory systems and documentation.
- Provide laboratory on-call support coverage for all aspects of laboratory operation.
- Work cross-functionally with other departments to ensure deliverables are met according to projected timelines.
- Verify timecards and SAP billing is completed accurately and on time.
- Perform the QC release for raw materials, isolated intermediates, and finished goods.
- Identify discrepancies, author out of specification and deviation investigations, and implement associated CAPAs.
- Familiarity with compliance requirements within cGMP, safety, and regulatory environments.
- Operational knowledge of analytical instrumentation like HPLC/UPLC, GC, IC, ICP, FTIR, UV-VIS equipment, and data stations.
- Demonstrated computer literacy, including word processing, spreadsheets, structural drawings, and databases.
- Strong chemistry knowledge.
- Bachelor's Degree in Chemistry, Pharmacy, or closely related field required. Advanced degree highly beneficial.
- 5 or more years of experience in manufacturing support laboratory in the pharmaceutical industry, preferably API and/or intermediate experience.
- Hands-on experience with pharmaceutical laboratory management required. Management of 24/7 lab operation highly beneficial.
Cambrex is an Equal Opportunity / Affirmative Action employer and will consider all qualified applicants for employment without regard to race, color, religion, gender, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
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