Quality Operations Specialist
Core
Senior QA point of contact for Quality RAPID events, performing in-process QA checks, and supporting change control and hold tag activities in a pharmaceutical manufacturing environment.
Role type
Senior IC quality operations specialist (pharmaceutical manufacturing)
Builds
Drug development and commercial manufacturing services (Oral Solid Dose products)
Domain
Pharmaceutical manufacturing / Biologics / Medical devices
Required skills
cGMP/GDP knowledge, deviation report authoring, root cause analysis, batch record review, SAP/ERP familiarity, cleanroom operations, GMP documentation checks
Preferred skills
pharmaceutical manufacturing experience, biologics experience, medical device experience, change control management
Technologies
SAP
Responsibilities
Facilitate Quality RAPID events and disposition determination, author deviation reports, perform in-process QA checks prior to batch initiation, support change control activities, perform manufacturing barrier checks, manage hold tag creation and removal, conduct Fit & Finish audits
Seniority
Senior, hands-on IC
