Job Details

  • Title: QA Associate
  • Code: RCI-6978
  • Location: Thousand Oaks California (CA) 91320
  • Posted Date: 02/13/2020
  • Duration: 24 Months
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  Job Description

Schedule will need to be flexible to support 24/7 operations, this includes days, swings, and night shifts.

This role supports Quality Assurance department under the Operations organization providing daily oversight of Drug Substance Manufacturing production activities.

  • Provides support and compliance oversight to Manufacturing, Facilities, Engineering, Supply Chain, and other support staff in the execution of their processes, procedures, and use of quality systems
  • Evaluate compliance issues, provide recommendations, and assure progress to completion
  • Represent functional area quality for the Bulk Quality Assurance department in the execution of projects necessary to achieve departmental operational excellence goals
  • Must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.
  • Electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs
  • Bachelor's Degree in a science field required
  • Must have 2-3 years experience in Drug Substance Manufacturing (Biotech)
  • 2-3 years experience in Quality Assurance/Manufacturing/engineering
  • 1-2 years experience in batch record review