Specialist QA Shop Floor
Core
Provide 24x7 quality oversight and compliance monitoring for manufacturing, QC labs, label operations, and warehouse operations to ensure adherence to cGMP and company standards.
Role type
Specialist QA Shop Floor (Quality Assurance)
Builds
Compliant pharmaceutical manufacturing and supply chain operations
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
cGMP compliance, batch record review, deviation management, CAPA management, change control, problem-solving, technical writing, cleanroom operations, GxP electronic systems (MES, ERP), regulatory knowledge (FDA/EMA)
Preferred skills
Experience with biopharmaceuticals or cell therapy manufacturing, proficiency with digital tools (Power Automate, Smartsheet, Tableau)
Technologies
Manufacturing Execution Systems (MES), Enterprise Resource Planning (ERP) such as SAP, laboratory information management systems, Microsoft Power Automate, Smartsheet, Tableau
Responsibilities
Provide routine quality on-the-floor oversight and triage unexpected events; interpret problems and communicate effectively to management; identify departures from approved procedures and escalate complex issues; perform operational verification in MES; observe manufacturing operations for cleanroom behaviors and aseptic techniques; review manufacturing batch records; act as designated Authorized Person (AP) for drug product release in specific markets; perform verification of issued drug product labels.
Seniority
Mid-level, hands-on IC
