Specialist-manufacturing Investigations

Amgen Australia Pty Ltd

North Carolina, US
Base: 114,990.00 usd - 139,433.00 usd; bonus/equit...
Major deviation investigations
Root cause analysis
Capa development
Join Amgen’s newest and most advanced drug substance manufacturing plant, the FleX batch facility, combining the latest in single-use technologies with traditional stainless steel equipment

Job Summary

  • Join Amgen’s newest and most advanced drug substance manufacturing plant, the FleX batch facility, combining the latest in single-use technologies with traditional stainless steel equipment.
  • Manage major deviation investigations, including assembling investigation teams, leading root cause analysis, development of CAPAs, and compliant documentation of all findings.
  • Amgen fosters an inclusive environment of diverse, ethical, committed and highly accomplished people who respect each other and live the Amgen values to continue advancing science to serve patients.

Matching Summary

Join Amgen’s newest and most advanced drug substance manufacturing plant, the FleX batch facility, combining the latest in single-use technologies with traditional stainless steel equipment.

Salary

Base: 114,990.00 USD - 139,433.00 USD; Bonus/Equity: Not specified; Benefits: Not specified

Skills & Requirements

Must-have

  • Major deviation investigations
  • Root cause analysis
  • CAPA development
  • GMP manufacturing
  • Cross-functional team leadership

Nice-to-have

  • Collaborative investigator
  • Structured problem-solving approach
  • Operational Learning Team strategies
  • Building effective relationships

Key Requirements

  • 10 years Quality Control experience with High school diploma/GED
  • 8 years Quality Control experience with Associate’s degree
  • 4 years Quality Control experience with Bachelor’s degree
  • 2 years Quality Control experience with Master’s degree
  • 2 years Quality Control experience with Doctorate degree
  • 5+ years related work experience in biotech/pharma
  • Experience with compliance and quality systems
  • Experience leading complex investigations
  • Demonstrated project management ability

Work Rights

Not specified

Tailored Resume

Cover Letter