Senior Quality Assurance Specialist

Proclinical is seeking a Senior Quality Assurance Specialist for a leading biopharmaceutical company located in Santa Monica, CA.

Job Responsibility:

• Work closely with and provide quality oversight across functions (across network site QA, Global RM and Regents QC and Tech Excellence, Supply Chain, SQM, Process Development, Regulatory Affairs, Manufacturing) within Kite and externally to assure compliance and strong relationships
• Support strong partnership with network wide site QA groups to ensure global RM and Regents QA operations are continuously improved
• Perform a wide variety of activities to ensure compliance with applicable quality objectives and regulatory requirements including but not limited to:
• RM documentation review and ensure resolution of issues to release raw materials
• Review and approval of raw material OOS, Deviations and CAPAs

Skills and Requirements:

• 5+ years of experience in a GMP environment with BS degree in the biological sciences or related field
• 3+ years of experience in a GMP environment with MS degree in the biological sciences or related field
• In-depth knowledge of and ability to apply GMP in conformance to US, EU and ROW standards
• Proficient in cGMP regulations, quality systems and regulatory requirements.
• Experience writing, evaluating and closing investigations, CAPAs and change control records.

If you are having difficulty in applying or if you have any questions, please contact Tucker Lee at (+1) 215-660-3706 or t.lee@proclinical.com.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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