Deviation Investigator
Core
Analyze and investigate deviations or non-conformances in biologics manufacturing using root cause analysis to ensure product quality and regulatory compliance.
Role type
Quality Assurance Deviation Investigator
Builds
Corrective and preventive actions (CAPAs) and compliant documentation for biologic drug manufacturing
Domain
Biopharmaceuticals / Biologics Manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
root cause analysis, CAPA development, data analysis, regulatory compliance knowledge, cross-functional collaboration, documentation, problem-solving
Preferred skills
biologics manufacturing experience, Quality Management System (QMS) usage, LEAN/six sigma, FDA/EMA/GMP knowledge
Technologies
Veeva, Trackwise
Responsibilities
Manage deviation investigations and lead root cause analysis teams, document findings in a compliant manner, collaborate with cross-functional teams to implement CAPAs, communicate investigation progress to leadership, participate in client communications, and continuously improve investigation processes.
Seniority
Mid-Senior, hands-on IC