Product Compliant Investigator II - Medical Device
Core
Investigate and resolve product complaints in a regulated pharmaceutical CDMO environment to maintain cGMP compliance and protect product quality.
Role type
Product Compliant Investigator II
Builds
Investigation reports and root cause analysis documentation
Domain
Pharmaceutical manufacturing / CDMO / Quality Assurance
Deliverable
dashboards & analysis
Required skills
cGMP regulations knowledge, root cause analysis, complaint investigation, CAPA support, cross-functional collaboration, audit/inspection support
Preferred skills
GMP investigation experience, CDMO or manufacturing experience
Technologies
Quality management systems
Responsibilities
Perform product complaint investigations of low to moderate complexity, Collect and assess data for root cause analysis, Draft investigation reports, Escalate quality or patient safety concerns, Support CAPA implementation and tracking, Assist with audits and inspections
Seniority
Mid-level, hands-on IC
