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 leading critical quality processes including deviations, CAPAs, change controls, and batch dispositions within a GMP-regulated environment.
Candidates will benefit from a comprehensive Total Rewards Plan including health coverage, retirement savings, stock incentives, and flexible work models.
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 with company contributions
Skills & Requirements
Must-have
Commissioning and Qualification support
New Product Introduction experience
Quality systems management (CAPA, Deviations)
Change control process execution
Batch disposition activities
GMP regulated environment knowledge
Nice-to-have
Packaging operations experience
Continuous improvement initiatives
Cross-functional collaboration skills
Flexible shift availability
Root cause analysis expertise
Key Requirements
Doctorate OR Master's + 2 years Quality experience OR Bachelor's + 4 years OR Associate's + 8 years OR High School + 10 years
Bachelor's degree in Life Sciences or Engineering preferred
3+ years of Quality Assurance experience in GMP environment
Knowledge of cGMP and GDP requirements
Ability to work flexible shifts including weekends