Quality Operations Specialist
Core
Ensure highest quality standards across pharmaceutical manufacturing operations, supporting drug development and commercial manufacturing services.
Role type
Quality Operations Specialist (GMP)
Builds
Pharmaceutical products including controlled/sustained release dosage forms, osmotic release forms, and abuse-deterrent technologies
Domain
Pharmaceutical manufacturing / Biologics
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
cGMP/GDP knowledge, FDA/EMA regulatory compliance, deviation report authoring, batch record review, change control management, manufacturing barrier checks, SAP/ERP familiarity, root cause analysis, cleanroom operations
Preferred skills
biologics experience, batch record review expertise, SAP proficiency
Technologies
SAP
Responsibilities
Serve as Senior QA point of contact for Quality RAPID events, author deviation reports, perform in-process QA checks prior to batch initiation, support change control activities, perform manufacturing barrier checks, manage hold tag creation/removal, conduct Fit & Finish audits, coach operations personnel on GMP compliance
Seniority
Mid-level, hands-on IC
