Senior Specialist, MSAT Investigations
Core
Investigate manufacturing deviations (Notice of Event, Minor, Major, Critical) to determine root cause and define corrective actions to prevent recurrence at the Juno Manufacturing Plant.
Role type
Senior individual contributor deviation investigator
Builds
Deviation closure reports and Corrective and Preventive Actions (CAPA)
Domain
Biopharmaceutical manufacturing / Quality Assurance
Required skills
Root cause analysis, CAPA facilitation, GEMBA, Human and Organizational Performance (HOP) principles, technical writing, data collection, trend analysis, regulatory compliance knowledge
Preferred skills
FDA/EMA regulation experience, biotechnology or cellular therapy field experience
Technologies
Electronic quality record management systems, RCA tools
Responsibilities
Manage deviations to achieve right first time and on-time closure; Partner with investigation teams to align on investigation plans and root cause; Facilitate CAPA definition and implementation; Lead deep-dive analysis of department-specific trends; Conduct GEMBA walks and interviews to identify failure modes; Apply HOP principles to investigations; Utilize multiple RCA tools appropriately.
Seniority
Senior, hands-on IC