Manufacturing QA Associate (2nd Shift)
Core
Provide quality oversight of drug substance manufacturing floor activities, ensuring GMP compliance and real-time decision-making.
Role type
Manufacturing QA Associate (2nd Shift)
Builds
Drug substance manufacturing batches
Domain
Pharmaceutical manufacturing / GMP compliance
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP compliance, batch record review, deviation investigation, housekeeping monitoring, data integrity, regulatory knowledge (ICH Q7, 21CFR211), analytical test result review
Preferred skills
Experience in Quality Assurance in GMP facilities, drug substance manufacturing, microbiology or related field
Technologies
GMP documentation systems, batch record software
Responsibilities
Execute real-time review of batch documentation, perform GMP walkthroughs, initiate and assist in deviation investigations, execute room and line clearances, support transfer of master cell banks, review manufacturing analytical testing
Seniority
Mid-level, hands-on IC
