Specialist, Field Quality
Core
Provide quality assistance and oversight to operations for in-process intermediates and manufactured products, ensuring compliance with GMP regulations.
Role type
Quality Specialist (Manufacturing)
Builds
Manufactured pharmaceutical products
Domain
Biopharmaceuticals / cGMP Manufacturing
Required skills
cGMP regulations knowledge, batch record review, GMP area walkthroughs, electronic/paper documentation compliance, deviation support, alarm/logbook review
Preferred skills
Biotech bulk/finished product manufacturing knowledge, analytical testing, electronic batch record systems (DeltaV), US/EU regulatory familiarity
Responsibilities
Perform routine manufacturing batch production record review, conduct walkthroughs of GMP areas, support return to service and inspection readiness walkthroughs, review electronic and paper documentation for compliance, support quality review of manufacturing deviations, support release of incoming or manufactured products, perform routine QA floor support activities
Seniority
Entry to Mid-level, hands-on IC
