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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