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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 Skill Sets:
  • Quality Assurance experience
  • Experience with technical methods
  • Experience with combination products

Day to Day Responsibilities:                
  • Review and approve FP Mechanical/Physical methods, method development reports, user requirements, method validation reports and method transfer reports
  • Provide oversight to ensure accuracy and precision of methods to measure final product specifications
  • Review material characterization data, work with Regulatory to inform teams of any regulatory requirements that must be met
  • Facilitate PAI readiness for notified bodies and act as escort
  • Review method transfers across sites and suppliers to provide quality perspective and approval
  • Provides advice to regulatory on submission strategies associated with platforms and physical methods
  • Inform other Quality functions of any material requirements
  • Provide quality expertise and technical knowledge to Final Product Key External Initiative (KEI)
  • Co-develop training materials for method transfers and stability method transfers with FPT Core Technologies
  • Co-develop training materials for stability method transfers with FPT Core Technologies
       "This posting is for Contingent Worker, not an FTE"
 

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