Supervisor of Quality Control Operations
2 weeks ago
Position Overview:
As a key member of the Cambrex team, the Quality Control Supervisor will report directly to the PSG Manager. This role encompasses supervisory oversight, technical guidance, and support for laboratory personnel engaged in quality assurance processes.
Key Responsibilities:
- Oversee daily prioritization of quality control testing, ensuring optimal staff and equipment utilization.
- Ensure the proper maintenance of laboratory instruments, including equipment qualification and preventative maintenance, while assisting with troubleshooting and minor repairs as needed.
- Facilitate training and provide troubleshooting assistance for laboratory staff.
- Review completed laboratory tests to ensure timely release of data, reports, and materials.
- Manage the status of offsite sample testing efficiently.
- Uphold cGMP standards and maintain laboratory systems at required compliance levels.
- Draft and review documentation to support laboratory operations and production initiatives.
- Maintain comprehensive laboratory systems and documentation.
- Provide on-call laboratory support on a rotating basis, covering all aspects of laboratory operations, including environmental and raw material testing.
- Collaborate cross-functionally with departments such as Operations and Production to meet project timelines.
- Verify accuracy of timecards and SAP billing in accordance with site-specific timelines.
- Conduct quality control release for raw materials, intermediates, and finished products.
- Identify discrepancies and initiate investigations for out-of-specification results, implementing corrective actions as necessary.
Qualifications and Skills:
- Understanding of compliance requirements within cGMP, safety, and regulatory environments.
- Operational expertise with analytical instruments such as HPLC/UPLC, GC, IC, ICP, FTIR, and UV-VIS.
- Proficient in computer applications, including word processing, spreadsheets, and databases, preferably in a Windows environment.
- Strong foundational knowledge in chemistry.
Educational Background:
- Bachelor's Degree in Chemistry, Pharmacy, or a closely related field is required; an advanced degree is advantageous.
- A minimum of 5 years of experience in a manufacturing support laboratory within the pharmaceutical sector, with a preference for API and/or intermediate experience.
- Hands-on experience in managing pharmaceutical laboratory operations is essential, with experience in 24/7 lab management being highly beneficial.
All requirements are subject to possible modifications to reasonably accommodate individuals with disabilities.
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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