Senior QA Specialist: Validation, Audits & Compliance
Weil Group, Inc
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Job summary
Amgen seeks a QA professional to support its Quality Assurance program under minimal supervision. The role covers reviewing MPs, approving validation protocols, site audits, and leading QA-related investigations.
The ideal candidate will have strong cross-functional leadership, regulatory interaction experience, and the ability to manage projects from inception to completion. The position emphasizes independent work and adherence to QA standards.
Qualifications
- Advanced degree or equivalent experience in a related field.
- Experience with QA, QAL, validation and process development.
- Ability to lead cross-functional teams and manage projects.
- Strong interaction with regulatory agencies.
Responsibilities
- Review and approve product MPs.
- Approve process validation protocols and reports for manufacturing processes.
- Lead site audits and investigations.
- Own site quality program procedures and related controls.
- Provide lot disposition and authorize lots for shipment.
- Review and approve change controls and EMS/BMS alarms.
- Support automation and facilities/environmental programs.
- Review risk assessments and CAPA records.
- Designee for QA manager on local CCRB.
- Represent QA on NPI team.
Skills
Education
Job description
Amgen seeks a QA professional to support its Quality Assurance program under minimal supervision. The role covers reviewing MPs, approving validation protocols, site audits, and leading QA-related investigations.
The ideal candidate will have strong cross-functional leadership, regulatory interaction experience, and the ability to manage projects from inception to completion. The position emphasizes independent work and adherence to QA standards.
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