R&D Partners
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Clinical QA Manager
Job Description
Our Bay Area client is recruiting for a Clinical QA Manager to join their growing team.
Summary:
R&D Partners is an equal opportunity employer.
Summary:
- Provide quality oversight for internally manufactured early-stage products and starting materials
- Provide support for audits and inspections of CDMOs and internal manufacturing and testing organizations
- Provide quality oversight to release clinical phase 1 and 2 materials ensuring compliance with phase appropriate lot release requirements
- Review early-stage analytical testing in support of GLP and GMP clinical protocols and production activities
- Management of quality system records including change requests, deviations and CAPA for the early-stage manufacturing and analytical science departments.
- BA/BS with 7+ years of experience with biotechnology, pharmaceuticals or human healthcare industries
- 7+ years experience in pharmaceutical Compliance, Engineering, Manufacturing, or Quality functions.
- Demonstrate in-depth understanding and application of phase appropriate GMP principles, concepts, practices and standards in the US and internationally.
- $51-60 per hour (Dependent on Experience)
R&D Partners is an equal opportunity employer.