Manufacturing Investigations Lead - Deviation & CAPA
BioSpace
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Benefits offered by this job
Job summary
Amgen is seeking a Specialist-Manufacturing Investigations in North Carolina to lead major deviation investigations at the biologics drug substance facility. You will interface across GMP manufacturing, Process Development, Facilities, Automation, EHSS, and Quality, ensuring investigations are conducted thoroughly and documented to drive process improvements.
The role requires extensive experience with complex investigations, cross-functional project management, and strong technical writing.
Qualifications
- Doctorate degree required.
- Masters with 3 years of related experience.
- Bachelor's degree or 5 years of related experience.
- Associates degree with 10 years of related experience.
- High school diploma or GED with 12 years of related experience.
Responsibilities
- Manage major deviation investigations with cross-functional teams.
- Lead root cause analysis and development of CAPAs.
- Document findings in compliant, audit-ready records.
- Drive improvements to the investigation process.
- Present investigations to regulators, internal auditors, and management.
- Coordinate cross-functional teams to meet milestones.
- Communicate progress to leadership clearly.
Skills
Education
Job description
Amgen is seeking a Specialist-Manufacturing Investigations in North Carolina to lead major deviation investigations at the biologics drug substance facility. You will interface across GMP manufacturing, Process Development, Facilities, Automation, EHSS, and Quality, ensuring investigations are conducted thoroughly and documented to drive process improvements.
The role requires extensive experience with complex investigations, cross-functional project management, and strong technical writing.
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