Quality Assurance Associate at Rangam in Thousand Oaks, CA

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Description

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

Under general supervision, the role 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.
Duties include electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs.
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.
Electronic batch record review, documentation review, SOP and Manufacturing Procedure revision, approval, work order approval, and quality approval of Deviations/Nonconformances and CAPAs.

Candidates must have the ability to work in a team matrix environment and independently interact with various levels to drive items to completion.

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

Education:

  • 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

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