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Quality Assurance Senior Specialist

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                                                                                 
  • Medical device or combination product
  • Deviation or nonconformance / CAPA (Corrective Action or Preventative Action) / EV (Effective Verification)
  • Change Control experience

Day to Day Responsibilities:                        
  • Provide oversight and SME support of the Deviation/CAPA/EV and change control processes and ensure compliance to the procedures.
  • Own or provide Quality oversight of Deviation/CAPA/EV and change control records, with attention to detail, review for completeness, accuracy and timeliness.
  • Facilitate cross functional CAPA and change control board forums to enable systematic monitoring and execution of the process, including creating meeting minutes, confirming agendas and presenters, and tracking action items to closure.
  • Generate and monitor site Deviation/CAPA/EV and change control KPI’s, trend data on a periodic basis and document reports as required, supporting network subject matter experts
  • Apply working knowledge of design controls, risk management, complaints investigations, document management and other QMS processes.
  • Identify and participate in opportunities for improvement in creating an efficient, robust process.

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

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