Sr. Specialist Manufacturing
Amgen · West Greenwich, RI
CMCFull-timeCompany career page
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Role summary
Amgen seeks a Senior Specialist in Manufacturing to lead complex major deviation investigations at its Rhode Island facility. This individual contributor will provide technical expertise for high-impact investigations, mentor cross-functional teams, and drive operational excellence through science-based problem-solving and continuous improvement initiatives.
What they're looking for
- Bachelor's degree with 6+ years quality/manufacturing experience, or equivalent combination
- Expertise in deviation management, root cause investigations, CAPA, GMP quality systems
- Experience as technical representative during audits and regulatory inspections
- Ability to lead complex cross-functional projects with competing priorities
- Strong written, verbal, and presentation skills with stakeholder influence capability
- Proven ability to build partnerships and drive alignment without formal authority
What you'll be doing
- Serve as technical lead and major deviation owner for complex, high-impact investigations
- Lead in-field investigation activities, coach teams, and drive rigorous fact-finding
- Act as subject matter expert to advance technical capability through mentoring and knowledge sharing
- Represent organization as technical authority during audits, inspections, and regulatory interactions
- Drive continuous improvement initiatives including evaluation of AI-enabled investigation tools
Privacy & handoff
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