Quality Assurance Lead — GMP, CAPA & Audits
Cis-International-LLC
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Job summary
Amgen seeks a Quality Assurance professional to support its QA program at the Juncos, PR site. Responsibilities include approving MPs and validation protocols, leading investigations, and owning quality procedures.
The role requires collaboration across QMS, manufacturing, validation, and environmental programs, with strong regulatory interaction. The ideal candidate will bring extensive QA experience, ability to manage deviations, CAPAs, and changes, and bilingual communication skills in
Qualifications
- Doctorate or Masters with related experience required.
- Bachelor degree with related experience required.
- Associates with related experience acceptable.
- High school/GED with extensive related experience accepted.
Responsibilities
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Release of sanitary utility systems.
- Lead site audits.
- Own site quality program procedures.
- Review Risk Assessments.
- Support Automation activities.
- Review and approve Work Orders.
- Review EMS/BMS alarms.
- Approve change controls.
- Provide lot disposition and authorize lots for shipment.
Skills
Education
Tools
Job description
Amgen seeks a Quality Assurance professional to support its QA program at the Juncos, PR site. Responsibilities include approving MPs and validation protocols, leading investigations, and owning quality procedures.
The role requires collaboration across QMS, manufacturing, validation, and environmental programs, with strong regulatory interaction. The ideal candidate will bring extensive QA experience, ability to manage deviations, CAPAs, and changes, and bilingual communication skills in
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