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Quality Assurance Senior Associate

Thousand Oaks, CA
Day to Day Responsibilities:    
  • 75% on the manufacturing floor oversight
  • electronic batch record review/batch record review
  • GMP review and approval
  • Quality contact for events, minor deviations and CAPAs

  • Day shift 8-5pm. Possibility of this position of being 2nd shift (2-11pm).
  • This role supports Amgen’s Quality Assurance program under the Manufacturing Plant QA organization providing daily oversight Cell Culture and Purification.
  • Under general supervision, the role provides support and compliance oversight to MFG and F&E staff in the execution of their processes, procedures, and use of quality systems.
  • Duties include batch record review, SOP and MP revision approval, work order approval, and quality approval of events, deviations and CAPAs.
  • The candidate will be required to evaluate compliance issues, provide recommendations, and assure progress to completion.
  • The candidate will also represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals.
  • Candidates must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.
  • Must have strong communication skills (both written and verbal)
  • Experience making decisions independently and determining when to elevate to management, as appropriate in an environment that balances business need, quality and compliance risk
  • At least 1-2 years of experience in industry
"This posting is for Contingent Worker, not an FTE"
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