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Quality Assurance Senior Associate

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Amgen

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Location:
United States , Thousand Oaks

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Contract Type:
Not provided

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Salary:

86928.00 - 106536.00 USD / Year

Job Description:

In this role as Senior Associate QA, you will be responsible for providing quality oversight to Drug Substance (DS) Cell Bank Manufacturing and Process Development (PD) laboratories at Amgen Thousand Oaks. 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. The role requires local, on‑site presence at the Amgen Thousand Oaks (ATO) site and is scheduled Monday through Friday, with occasional flexibility to support alternate shifts based on operational needs.

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

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

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
  • Stock-based long-term incentives
  • Award-winning time-off plans

Additional Information:

Job Posted:
March 26, 2026

Employment Type:
Fulltime
Work Type:
On-site work
Job Link Share:

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