Specialist Pqa

Amgen Inc

Base: $113,191.00 - $131,832.00 usd annually; bonu...
Quality systems experience (deviations, capa, change control)
Commissioning & qualification (c&q) support
New product introduction (npi) experience
Amgen is seeking a QA Specialist to strengthen quality systems for its B2 expansion and packaging operations while ensuring inspection readiness from day one

Job Summary

  • Amgen is seeking a QA Specialist to strengthen quality systems for its B2 expansion and packaging operations while ensuring inspection readiness from day one.
  • The role involves providing critical support for Commissioning & Qualification activities, New Product Introduction, and managing core quality processes like deviations and CAPAs.
  • Candidates will benefit from a comprehensive Total Rewards Plan including health benefits, retirement savings, stock incentives, and flexible work models where possible.

Matching Summary

Amgen is seeking a QA Specialist to strengthen quality systems for its B2 expansion and packaging operations while ensuring inspection readiness from day one.

Salary

Base: $113,191.00 - $131,832.00 USD annually; Bonus/Equity: Discretionary annual bonus and stock-based long-term incentives; Benefits: Comprehensive health, dental, vision, retirement plan, and flexible time-off

Skills & Requirements

Must-have

  • Quality Systems experience (deviations, CAPA, change control)
  • Commissioning & Qualification (C&Q) support
  • New Product Introduction (NPI) experience
  • cGMP and GDP regulatory knowledge
  • Flexible shift work availability

Nice-to-have

  • Packaging operations experience preferred
  • Continuous Improvement (CI) initiative drive
  • Strong analytical and problem-solving skills
  • Collaborative mindset in fast-paced environments
  • Experience with internal/external audits

Key Requirements

  • Doctorate OR Master's + 2 years OR Bachelor's + 4 years OR Associate's + 8 years OR High School + 10 years Quality experience
  • Bachelor's degree in Life Sciences or Engineering preferred
  • 3+ years of Quality Assurance experience in GMP-regulated environment
  • Sponsorship not guaranteed

Work Rights

Not specified

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