Quality Operations Specialist
Core
Senior QA point of contact for Quality RAPID events, deviation report authoring, in-process QA checks, and manufacturing barrier/hold tag management in a pharmaceutical cleanroom.
Role type
Senior IC quality operations specialist (GMP)
Builds
Drug development and commercial manufacturing services (Oral Solid Dose)
Domain
Pharmaceutical manufacturing / Biologics / Medical devices
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GDP knowledge, deviation investigation, batch record review, SAP/ERP familiarity, root cause analysis, GMP documentation, cleanroom operations
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 and barrier checks, manage hold tags and SAP status changes, conduct Fit & Finish audits, coach operations personnel on GMP compliance
Seniority
Senior, hands-on IC
