Quality systems (deviations, capa, change control)
Amgen is seeking a QA Specialist to strengthen quality systems for the B2 expansion and ensure inspection readiness from day one
Job Summary
Amgen is seeking a QA Specialist to strengthen quality systems for the B2 expansion and ensure inspection readiness from day one.
The role involves providing critical support for Commissioning & Qualification activities and embedding quality requirements during New Product Introduction.
Candidates will collaborate with cross-functional teams including Packaging, Engineering, and Supply Chain to drive continuous improvement and compliance.
Matching Summary
Amgen is seeking a QA Specialist to strengthen quality systems for the B2 expansion and ensure inspection readiness from day one.
Salary
Base: $113,191.00 - $131,832.00 USD annually; Bonus/Equity: Discretionary annual bonus program and stock-based long-term incentives; Benefits: Comprehensive health/welfare plans, retirement savings, and flexible time-off
Skills & Requirements
Must-have
Bachelor's degree or equivalent experience
GMP-regulated environment experience
Quality Systems (deviations, CAPA, change control)
Commissioning & Qualification support
Flexible shift work availability
Nice-to-have
Packaging operations experience
New Product Introduction background
Continuous Improvement initiatives
Cross-functional collaboration skills
Analytical problem-solving mindset
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
3+ years of Quality Assurance experience in GMP-regulated environment
Knowledge of cGMP and GDP requirements
Ability to work flexible shifts including weekends