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 / Life Sciences
Required skills
GMP compliance, batch record review, documentation review, regulatory guidelines knowledge, computer systems proficiency
Preferred skills
Biotech manufacturing knowledge, analytical testing knowledge, electronic batch record systems, DeltaV systems
Technologies
MS-Word, Excel, DeltaV
Responsibilities
Quality floor support for minor and routine manufacturing activities, Perform routine manufacturing batch production record review, Perform walkthroughs of GMP areas, Support return to service and manufacturing inspection readiness walkthroughs, Assure electronic and paper documentation compliance, Support quality review of manufacturing deviations, Support release of incoming or manufactured products
Seniority
Entry to Mid-level
