Quality Control Manager for Analytical Services
4 days ago
**Job Overview**
The Quality Control Chemistry Manager will oversee the planning, organization, and direction of routine activities of the QC staff. This includes coordinating all raw material testing and release for use in GMP production. The manager will lead tech transfer activities of qualified analytical methods from designated donor laboratories.
The Chemistry Manager will play a key role in selecting qualified personnel to staff the QC chemistry laboratory. They will report to the Director, QC, and work closely with other departments to ensure compliance with established specifications and procedures.
Primary Responsibilities:
- Manage the QC Chemistry Staff, including hiring, supervision, coaching, mentoring, discipline, and performing annual review assessments.
- Coordinate and oversee QC analytical testing for GMP batch release and stability testing.
- Ensure QC equipment is maintained in a qualified GMP state.
- Prepare, review and execute tech transfer, qualification and validation protocols and reports as needed.
- Write, revise, and review Standard Operating Procedures (SOPs) and other Good Manufacturing Practices (GMP) documentation.
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