Root Cause Expert
Core
Determine true root causes for operational issues and implement effective Corrective and Preventive Actions (CAPAs) to prevent manufacturing deviations in a regulated environment.
Role type
Root Cause Analyst (RCA)
Builds
Robust root cause identification and CAPA implementation for production, quality control, and facilities deviations.
Domain
Biologics/Pharmaceuticals manufacturing
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
Root Cause Analysis (5-Whys, Fishbone/6M, TapRoot, Kepnor-Tregoe, Comparative Analysis), technical writing, data evaluation, trend analysis, cross-functional facilitation, CAPA implementation
Preferred skills
LEAN/six sigma experience, PPI tools, biology/biochemistry/engineering background
Technologies
Microsoft Office Tools
Responsibilities
Identify root causes and provide support for implementation of countermeasures, apply fundamentals of Root Cause Analysis including 5-Whys and Fishbone, provide root cause support for major investigations, facilitate cross functional teams to evaluate causal factors, provide written documented investigations, support implementation of CAPAs, communicate root cause findings and recommendations to leadership
Seniority
Junior to Mid-level, hands-on IC