Clinical QA Manager

2 weeks ago


Los Angeles, United States R&D Partners Full time

Job Description

Our Bay Area client is recruiting for a Clinical QA Manager to join their growing team.

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. Requirements:

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. Pay Scale:

$51-60 per hour (Dependent on Experience) R&D Partners is a specialist employment agency and recruitment business providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal opportunity employer. Login

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