Senior Quality Assurance Associate, Drug Substance
FUJIFILM Biotechnologies
Hybrid
Drug substance manufacturing under cgmp/gdp
Approve deviations capas change controls
Risk-based decision making
As the QA for drug substance operations, you’ll drive fast, high-quality decisions that improve right-first-time, shorten release, and de-risk tech transfers in a high-growth environment
Job Summary
As the QA for drug substance operations, you’ll drive fast, high-quality decisions that improve right-first-time, shorten release, and de-risk tech transfers in a high-growth environment.
FUJIFILM Biotechnologies offers a competitive salary and bonus package, health insurance, massage and physiotherapy, health check, fitness center, hybrid working, and a positive culture with traditions like Friday brunch and bell ringing for milestones.
You will contribute across a 55+ person QA team with clear decision rights, open doors, and colleagues who back you, enabling growth, recognition, and visible impact.
Matching Summary
As the QA for drug substance operations, you’ll drive fast, high-quality decisions that improve right-first-time, shorten release, and de-risk tech transfers in a high-growth environment.
Skills & Requirements
Must-have
drug substance manufacturing under cGMP/GDP
approve deviations CAPAs change controls
risk-based decision making
inspection and audit readiness
documentation and procedure management
Nice-to-have
collaboration and open communication
coaching mindset on production floor
bias to action and crisp decisions
sharing wins and quick huddles
Key Requirements
5+ years drug substance manufacturing experience
degree in Biotechnology Pharmacy Medicine Chemistry Biology or related