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Sr Associate QA - Nights

Amgen Inc

Senior Associate Quality Assurance position supporting manufacturing operations on a night shift (7PM-7AM) at a biopharmaceutical manufacturing facility. The role involves on-floor quality oversight, regulatory compliance, and collaboration with manufacturing and quality teams during bulk drug substance operations.

Responsibilities

  • Provide quality oversight during manufacturing and on-the-floor analytical testing activities
  • Review and approve cGMP processes, procedures, batch records, deviations, and logbooks
  • Investigate and document deviations from established procedures per company protocols
  • Author, review, and approve quality documents including risk assessments and training materials
  • Alert senior management to potential quality, compliance, supply, or safety risks

Requirements

  • High school diploma/GED plus 4 years quality assurance or manufacturing experience
  • Or associate degree plus 2 years quality assurance or manufacturing experience
  • Or bachelor's degree plus 6 months quality assurance or manufacturing experience
  • Experience working in cGMP regulated environment
  • Proficiency in Microsoft Office applications
  • Knowledge of batch records and GMP documentation systems
  • Analytical testing experience preferred
Vacancy posted 3 days ago
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