QA Compliance Specialist
Joule Scientific Staffing - Montgomery County, PA

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Description:
  • Ensure that manufacturing is in compliance with company SOP's, GMP standards and DEA/FDA regulations
  • Ensuring that test results are in line with established specifications before raw materials, in-process materials, or finished drug substances are released, investigating any deviations that occur
  • Conducting final review of batch records and providing authorization to release lots
  • Reviewing causes of non-conformances and instituting corrective action (CAPA)
  • Assists with audit-ready initiatives
Requirements:
  • BS Chemistry
  • 4-5 years of experience working in QA/QC/Compliance for an API manufacturing facility in a FDA/DEA regulated environment (may consider someone with 5+ years of experience just working in API manufacturing)
  • Strong working knowledge of batch record review, and investigations into deviations
  • Experience working with trackwise/master control is preferred