Manufacturing QA Associate (2nd Shift)
Core
Provide quality oversight of drug substance manufacturing floor activities, ensuring GMP compliance and executing real-time batch documentation reviews.
Role type
Manufacturing QA Associate
Builds
Compliant drug substance batches
Domain
Pharmaceutical manufacturing (drug substance)
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 GMP facilities, drug substance manufacturing, CAPA management, change controls
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, review manufacturing analytical testing
Seniority
Mid-level, hands-on IC
