Senior Associate Quality Assurance
Amgen Inc
Senior Associate Quality Assurance position supporting drug product manufacturing operations at a biopharmaceutical facility. The role provides daily oversight of manufacturing areas, ensuring compliance with regulatory requirements and GMP standards in a Grade 8 cleanroom environment.
Responsibilities
- Provide daily oversight and quality support in drug product manufacturing areas with cleanroom gowning
- Perform manual visual inspection and review electronic batch records for GMP compliance
- Review and approve GMP documents, maintenance work orders, and minor quality deviations
- Evaluate compliance issues, provide recommendations, and ensure completion of quality records
- Support 24/7 production operations with flexible shift schedules across multiple rotating shifts
Requirements
- High school diploma/GED plus 4 years of GMP experience, or equivalent education-experience combination
- Demonstrated knowledge of GMP operations, SOPs, and documentation practices
- Ability to work flexible shift rotations including weekends in a 24/7 production environment
- Strong organizational and multitasking capabilities with effective written and verbal communication
- Experience evaluating documentation and operations against company procedures
- Preferred: Bachelor's degree in biochemistry, biology, chemistry, or related science field
Vacancy posted 8 days ago
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