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Specialist Quality Assurance

Thousand Oaks, CA
“This company requires all staff, staff augmentation external workers, and certain other external workers, in the United States and Puerto Rico to be vaccinated from COVID 19 as a condition of assignment at this company. In accordance with applicable law, this company will provide reasonable accommodations to staff augmentation external workers who 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 to this company, its operations, or its staff.

Top 3 Must Have Skill Sets:    
  • cGMP Experience with demonstrated ability to consistently deliver on-time, and high-quality results
  • Understanding of the applicable manufacturing/testing processes (i.e. API, Drug Substance, Drug Product, Packaging, Device manufacturing processes)
  • Ability to operate in a matrixed or team environment & operate in a matrixed or team environment
Day to Day Responsibilities:    
  • Ensure execution of applicable Systems and Processes is in alignment with Operating Standards
  • Identify key issues, needs, constraints of the External Quality/Supply organization and drive network solutions for resolution
  • Understanding and interpreting of applicable GMP Regulations pertaining to the System or Process of which the SME is representing
  • Communicate and ensure alignment on priority decisions
  • Provide tactical information to the networks (i.e., metrics to MR, data analysis, trending)
  • Drive continuous improvements and One this company mindset
Summary
Candidate must be vaccinated from COVID 19

Job Details: The successful candidate will be involved in ensuring execution of applicable systems and processes in alignment with this company standards. They will identify key issues, needs, constraints of the External Supply Quality/External Supply and drive network solutions for resolution. They will understand and interpret applicable GMP Regulations relating to supplier management and oversight of service providers ensuring company's existing process & procedures are fully aligned. They will provide tactical information to the networks (ie metrics to MR, data analysis, trending). They will drive continuous improvement with a Onethis company mindset.

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

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