Piper Companies is currently seeking a full-time, direct placement QA Manager for work at a leading CDMO in Nashville, TN .
The QA Manager will support all activities related to internal functioning and external, client-facing engagement.
Responsibilities of the QA Manager:
- Review final executed batch records/product to ensure compliance with approved procedures and communicate discrepancies with manufacturing operators/supervisors
- Conduct quality walk-throughs of the production, testing and warehouse locations
- Ensure that all required documents are accurate, including all batch related deviations
- Support routine preventive maintenance and calibration of equipment
- Manage all aspects of quality systems and quality operations for the facility
Qualifications of the QA Manager:
- 4+ years of relevant cGMP experience
- Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing
- Hands-on experience with batch record review and product disposition is preferred
- Bachelor’s degree in relevant science or engineering discipline is preferred or Associates degree and/or equivalent combination of education and experience is accepted
Compensation for the QA Manager:
- $130k
- Comprehensive Benefits package: Medical, Dental, Vision, 401K, PTO
Keywords: GMP, GLP, GXP, GCP, batch record management, batch record review, full-process manufacturing, cell therapy, deviations, junior role, maintenance, calibration, FDA, EMA, biopharmaceuticals, quality assurance, QA,
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