Description :
Bayer HealthCare Pharmaceuticals is a leading global specialty pharmaceutical and biotechnology company. With over $3 Billion in protein drug sales, Bayer ranks as the sixth largest biotech company in the world.
Berkeley, California is a multi-functional Bayer HealthCare site that houses the global headquarters for the Hematology/Cardiology business units, the headquarters of the global biotech product supply organization, and one of three major global R&D sites focusing on protein therapies. In fact, Berkeley is essentially the nerve center of Bayer HealthCare's biotech operations. With a focus on biopharmaceutical discovery, development, manufacturing, and commercialization, we believe our ability to advance improvements and innovations in patient care will be greatly enhanced by our fully integrated capabilities.
POSITION DESCRIPTION
This position supports Quality Assurance functions within the QA Development Products Group and reports to the QA Release Manager. The QA 3 is responsible for ensuring all clinical product documentations and product specifications are satisfactorily met prior to release of each individual lot manufactured at the Berkeley facility. Additionally, this position supports the coordination of release of clinical supplies as required to support material release.
Job responsibilities include:
• Compile and review clinical product lot packets, and other duties as assigned which will culminate in the release of a safe, efficacious quality clinical product
• Support clinical batch release by meeting standard lead times for the completion of fundamental lot disposition activities
• Perform the final technical review of Batch Production Records (BPRs) and test records, in accordance with regulatory requirements, current Good Manufacturing Practices (cGMPs), policies, and procedures
• Initiate discrepancies/observation associated with the technical review
POSITION REQUIREMENTS
• Minimum requirements are BS with 4+ years work experience
• Requires an understanding of pharmaceutical technology, including quality systems, quality engineering principles, and statistical methodology (should be sufficiently knowledgeable in these scientific disciplines to undertake product or process problem solving)
• Should be familiar with government regulations worldwide to assure conformance to country requirements, and have an understanding of Good Manufacturing Practices and Good Laboratory practices required for the release of product for human use to clinical studies
• Must possess the demonstrated ability to work cooperatively in peer relationships toward common goals to achieve company objectives
• Must be able to think strategically in a global fashion and on individual projects in order to conceive and execute operational plans
• Must be able to drive problem solving for the unit/team in uncharted areas by being able to think out of the box
• Must be able to analyze, plan, design, develop, implement, and document complex information
• Must exhibit attention to detail and familiarity with DMS, SAP, and ITS computer databases and Excel and Word computer applications