Specialist III – Quality Assurance, Systems
Core
Manage complex deviations, Out-of-Specification investigations, and Corrective and Preventive Actions (CAPAs) to ensure compliance and operational excellence in biologics manufacturing.
Role type
Senior Quality Assurance Systems Specialist
Builds
Quality management systems and compliance reporting for biologics development and manufacturing
Domain
Biopharmaceuticals / Biologics Manufacturing
Required skills
Deviation management, CAPA management, investigation leadership, stakeholder collaboration, technical training, document control, regulatory compliance
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