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Quality Assurance Manager

Thousand Oaks, CA
“This Company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and puerto rico vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations staff augmentation external workers qualify on the basis of a medical reason or a sincerely held religious belief, practice, or observance. Such accommodation may not pose an undue hardship this company, its operations, or its staff.”                                                        

Top 3 Must Have Skills        
  • 5+ years in computerized system validation
  • 5+ years in GxP computerized system supplier management
  • 3+ years leading regulated supplier evaluations/audits
(Years of experience is not total need rather focus on having a solid knowledge of these topics)

Day to Day Responsibilities:        
    
Primary Role: Quality resource to support execute the process for classifying, evaluating, approving, monitoring, and inactivating Computerized Systems GxP Suppliers, including:
Scheduling, performing, and/or assisting in GxP computerized systems supplier evaluations for Operations and R&D
  • Responsible for the creation, approval process (including working with the supplier and Amgen management), and maintenance of supplier evaluations, evaluation read-outs, mitigation plans, quality agreements, and supplier approval forms
  • Ensure issues of compliance matters are communicated to the quality manager
  • Provides and contributes to supplier monitoring and health
  • Contribute to continuous improvement initiatives


"This posting is for Contingent Worker, not an FTE"



 

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