Root Cause Analyst
Core
Determine true root causes for operational issues and implement effective Corrective and Preventive Actions (CAPAs) to reduce recurrence.
Role type
Root Cause Analyst
Builds
Quality improvements and process solutions for production, quality control, and facilities operations
Domain
Biologics/Pharmaceuticals manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root Cause Analysis methodologies (5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis), technical writing, data interpretation, trend analysis, cross-functional facilitation
Preferred skills
Lean Six Sigma Green Belt or Black Belt, experience in regulated environments
Technologies
Microsoft Office Tools
Responsibilities
Identify root causes and support implementation of countermeasures, provide root cause support for major investigations across production and quality, facilitate cross-functional teams to evaluate causal factors, provide written detailed investigations, support implementation of CAPAs, communicate root cause findings and recommendations to leadership
Seniority
Junior to Mid-level, hands-on IC