Specialist Manufacturing Investigations

What You Will Do
- Investigate major deviations in the Amgen North Carolina Biologics Drug Substance Manufacturing plant.
- Interface between GMP manufacturing teams and stakeholders (Process Development, Facilities & Engineering, Automation, EHSS, Quality).
- Ensure deviation investigations are successfully conducted and documented, and drive improvements to the investigation process.

Responsibilities
- Manage major deviation investigations: assemble teams, lead root cause analysis, develop CAPAs, and ensure compliant documentation.
- Drive improvements to the investigation process.
- Present investigations to regulatory inspectors, internal auditors, and management.
- Communicate investigation progress to impacted areas and leadership.
- Lead cross-functional teams through complex investigations and complete milestones on-schedule.
- Present complex topics to groups at various levels; quickly understand and clearly communicate complex issues.
- Build effective cross-functional relationships.
- Navigate ambiguity with structured problem-solving; apply inductive and deductive reasoning.
- Provide clear, concise technical writing.
- Use Operational Learning Team strategies to promote open collaboration and maximize findings.
- Develop tracking tools to ensure on-time closure and proactive review.

Basic Qualifications
- Doctorate degree
-or- Master’s degree + 2 years directly related experience
-or- Bachelor’s degree + 4 years directly related experience
-or- Associate’s degree + 8 years directly related experience
-or- High school diploma/GED + 10 years directly related experience

Preferred Qualifications
- 5+ years in biotech/pharma (manufacturing, process development, or quality assurance) with increasing responsibility.
- Compliance and root-cause analysis tools experience (e.g., 5-Whys, fishbone, Kepner-Tregoe, DOE); critical thinking, project management, quality systems.
- Science or Engineering degree.
- Experience leading complex investigations.
- Veeva QMS experience for deviation investigations and CAPAs.
- Demonstrated project management ability.
- Experience presenting to inspectors and during internal audits.
- Excellent written/verbal communication; strong interpersonal skills; matrix teamwork.

Benefits (Total Rewards Plan)
- Comprehensive employee benefits (Retirement and Savings Plan, medical/dental/vision, life/disability, flexible spending accounts).
- Discretionary annual bonus (or field sales incentive plan).
- Stock-based long-term incentives.
- Time-off plans and bi-annual company-wide shutdowns.
- Flexible work models/remote work where possible.

Application Instructions
- Apply now.