QA Manager

QA Manager

QA Manager

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Accentuate Staffing is partners with an expanding pharmaceutical company in the RTP area who is looking to expand there manufacturing team and has multiple QA Manager positions open!


  • Will manage up to 5 people
  • Create and maintain Site Master Validation Plan
  • Review of Batch Records and approve product disposition Review of analytical, stability test methods, protocols & reports
  • Release of raw materials, components, in-process materials and finished products. Review and approve investigation reports as applicable
  • Develop Site Quality Road Map for the initiation of Manufacturing GMP Quality Systems Establishing and maintaining Site SOPs in collaboration with Mfg. staff
  • Facilitate vendor audits


  • Minimum 10 – 15 years’ experience in Pharmaceutical Manufacturing QA position
  • Experience with Collection, issuance, destruction, and inventories of all DEA Regulated Controlled Substance /List Chemicals located within WHS Controlled Substance Vault/Cages
  • Must be able to review and write SOPs, review test methods, method validation protocols and reports as per FDA and ICH guidelines.
  • Experience with analytical, stability protocols, reports, batch records, change control, investigations, deviations and other relevant GMP documentation
  • Possess organization skills
  • Experience on deviation investigations for manufacturing and laboratory
  • Ability to train personnel on GMP regulations and requirements
  • Technical writing skill
  • Familiarity with cGMP regulations, FDA guidance documents and QbD