Specialist III – Quality Assurance, Systems
Core
Manage complex deviations, Out-of-Specification investigations, and CAPA systems to ensure compliance and operational excellence in biologics manufacturing.
Role type
Senior Quality Assurance Systems Specialist (Biologics/GMP)
Builds
Quality management systems and compliance frameworks for clinical biomanufacturing
Domain
Biopharmaceuticals / Biologics / GMP Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Deviation management, CAPA management, OOS investigation, Quality system maintenance, Metrics reporting, Process improvement, Technical training, Document control, Client communication
Preferred skills
None stated
Technologies
None stated
Responsibilities
Perform quality review and approval on deviations, laboratory investigations, and complaints; Oversee Corrective and Preventive Actions (CAPAs) opened in response to deviations; Address client comments on investigations; Participate in client calls to discuss investigation status; Provide technical assistance and training for personnel; File and maintain controlled documents
Seniority
Senior, hands-on IC
