Senior Associate Quality Assurance
About this role
About the Role Senior Associate Quality Assurance position supports Amgen’s Quality Assurance program under the Plant QA organization providing daily oversight of the Drug Product manufacturing areas. Under general supervision, the role provides support and quality oversight of our Drug Product Manufacturing facility, ensuring the execution of our processes, procedures, and use of quality systems aligns with regulatory requirements. What You'll Do
- Purposeful presence on the manufacturing floor (Form/Fill Grade 8 Gowning)
- 100% Manual Visual Inspection support, ASP/AQL performance, and QA Oversight Assessments
- Electronic batch review
- GMP Document (SOPs/FORMs) revision review/approval
- Review and approval of electronic Maintenance documentation Work Order/Job Plans
- Quality support and approval of minor deviations
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