Quality Operations Specialist
Core
Ensure highest quality standards and regulatory compliance on the pharmaceutical manufacturing floor, supporting drug development and commercial manufacturing of advanced dosage forms.
Role type
Senior Quality Operations Specialist (GMP)
Builds
Pharmaceutical products including controlled/sustained release forms, osmotic release dosage forms, liquid-filled hard capsules, and abuse-deterrent technologies
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, FDA/EMA regulatory compliance, deviation report authoring, root cause analysis, batch record review, SAP/ERP familiarity, cleanroom operations, GMP documentation checks, change control management, hold tag management, fit & finish audits
Preferred skills
Pharmaceutical manufacturing experience, biologics experience, medical device experience, batch record review experience, SAP experience
Technologies
SAP
Responsibilities
Serve as Senior QA point of contact for Quality RAPID events; Author clear, thorough, and scientifically sound deviation reports; Perform in-process QA checks prior to batch initiation; Support Change Control activities by creating and managing batch record insert-pages; Perform manufacturing barrier checks; Support hold tag creation and removal activities; Perform Fit & Finish audits of Manufacturing annually; Maintain a safe working environment and report potential hazards
Seniority
Senior, hands-on IC
