Investigator I / II
Core
Lead investigations into quality and safety events across manufacturing operations using root cause analysis and Human & Organizational Performance (HOP) principles.
Role type
Senior IC Quality & Safety Investigator
Builds
Corrective and preventive actions (CAPAs) to reduce recurrence risk and enhance operational reliability
Domain
Manufacturing / Quality Management Systems / Regulatory Compliance
Required skills
Root cause analysis, Data gathering and analysis, Technical writing, Stakeholder facilitation, Regulatory compliance knowledge, Critical thinking, Cross-functional collaboration, CAPA development
Preferred skills
Human & Organizational Performance (HOP) principles, Systematic cause analysis methodologies (Event & Causal Factor Charting, Logic Fault Tree Analysis), cGMP/cGLP/OSHA/FDA/EMA knowledge, Regulatory inspection/audit experience
Responsibilities
Lead investigations for quality deviations and safety incidents, Conduct interviews and analyze data to identify root causes, Author compliant investigation reports, Partner with stakeholders to develop CAPAs, Present findings during internal and external audits
Seniority
Mid-level to Senior, hands-on IC