QA Operations Specialist - Shift Based
Core
Ensure quality and compliance for innovative Radioligand Therapies in a manufacturing environment.
Role type
QA Operations Specialist
Builds
Manufacturing operations for life-changing cancer therapies
Domain
Biopharmaceutical manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GxP compliance, batch record review, SOP/CAPA/Deviation management, environmental monitoring, regulatory inspection support, continuous improvement
Preferred skills
Cross-functional collaboration, operational excellence, quality training delivery
Technologies
cGMP systems, batch record software
Responsibilities
Review and approve test records for batch release, SOPs, CAPAs, and deviations; Perform shop floor oversight and provide compliance guidance; Conduct live batch record review and execute acceptable quality limit inspections; Support regulatory inspection readiness and maintain site cGMP compliance; Deliver quality training to strengthen quality culture.
Seniority
Mid-level, hands-on IC
