Senior Specialist, QA Shop Floor
Core
Provide 24x7 quality oversight and compliance monitoring for manufacturing, QC, warehouse, and label operations in a biopharmaceutical setting.
Role type
Senior Specialist, QA Shop Floor (hands-on IC)
Builds
Ensures compliance with cGMP and internal policies across production and supply chain operations.
Domain
Biopharmaceuticals / Manufacturing / Quality Assurance
Required skills
cGMP knowledge, regulatory guideline interpretation, data analysis, procedural document authoring, deviation assessment, cross-functional negotiation, training delivery, risk assessment participation, change control support, authorized person (AP) release execution
Preferred skills
FDA/EMA regulations experience, cell therapy manufacturing experience, MES/ERP system proficiency, STEM degree
Technologies
Manufacturing Execution systems (MES), Enterprise Resource Planning (ERP), MS Office
Responsibilities
Provide on-the-floor quality oversight to Manufacturing/QC/Warehouse/Packout/Label Operations; Identify and respond to departures from approved procedures and clean room behaviors; Review and approve return to service plans for non-routine maintenance; Coordinate area walkthroughs and lead Gemba walks; Author, review, and approve procedural documents; Independently assess discrepancies and approve deviations; Perform verification and reconciliation of issued drug product labels; Act as designated Authorized Person (AP) for Certification/Release of Supply where required.
Seniority
Senior, hands-on IC
