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In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance manufacturing facilities at Amgen Thousand Oaks, working within a shift system. Under general supervision, you will support and ensure compliance for Manufacturing, Facilities, and Engineering staff in their processes, procedures, and use of quality systems. You will engage directly with a diverse range of partners, establishing effective working relationships with production operators, line leads, shift supervisors, warehouse staff, facilities, maintenance, and engineering teams. This role requires your local presence at the Amgen Thousand Oaks (ATO) site. This is a Sunday-Wednesday schedule and requires availability across the three different shifts (with rotations every 6 months): Day Shift, Swing Shift, and Night Shift.
Job Responsibility:
Provide daily guidance and support to Production staff on compliance with Standard Operating Procedures (SOPs) and Work Instructions
Maintain a strong presence in Drug Substance (DS) areas to oversee GMP operations and quality systems
Serve as the first point of contact for quality-related production queries during DS operations
Lead, mentor, and coach Operations and support personnel on quality matters, fostering a strong Quality culture at the site
Review and approve batch production records and other GMP documentation to support daily operations
Compile and review batch records for manufactured lots in preparation for batch disposition
Own, review, and approve controlled documents, including SOPs, Work Instructions, and Forms
Collaborate effectively within a team matrix environment
Work across a three shift rotation including night shift
Requirements:
High school/GED + 4 years quality assurance work experience
Associate’s + 2 years quality assurance work experience
Bachelor’s + 6 months quality assurance work experience
Master's
Quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
Nice to have:
Quality and manufacturing experience in biotech or pharmaceutical industry
Bachelor’s Degree in a Science Field
Ability to successfully manage workload to timelines
Familiarity with basic project management tools
Demonstrated ability to consistently deliver on-time, and high-quality results
Ability to operate in a matrixed or team environment
What we offer:
A comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts
A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan