Specialist QA Shop Floor
Core
Provide 24x7 quality oversight and compliance monitoring for manufacturing, QC labs, label operations, and warehouse operations at a biopharmaceutical site.
Role type
Specialist QA Shop Floor
Builds
Ensures compliance with cGMP and company policies across site operations
Domain
Biopharmaceuticals / Manufacturing
Required skills
cGMP compliance, batch record review, deviation management, investigation analysis, CAPA management, cleanroom operations, MES/ERP systems proficiency, change control, product complaint handling, aseptic technique observation, GMP documentation review
Preferred skills
FDA/EMA regulatory experience, cell therapy manufacturing knowledge, Authorized Person (AP) release certification, Microsoft Power Automate/Smartsheet/Tableau proficiency
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; Identify departures from approved procedures and respond to issues; Perform operational verification within MES; Observe manufacturing operations for cleanroom behaviors and aseptic techniques; Review manufacturing batch records for compliance; Independently approve deviation records; Perform verification and reconciliation of issued drug product labels; Act as designated Authorized Person (AP) for supply release in specific markets.
Seniority
Specialist, hands-on IC
