Laboratory GMP Compliance Coordinator
Core
Manage GMP documentation and training programs for clinical manufacturing laboratories, ensuring compliance with company requirements and supporting audit readiness.
Role type
GMP Compliance Coordinator (Documentation & Training)
Builds
GMP-compliant documentation systems and training curricula for clinical trial services
Domain
Life Sciences / Clinical Research / GMP Compliance
Required skills
GMP documentation management, training curriculum development, SOP writing, change control, deviation investigation, electronic document management systems (EDMS), learning management systems (LMS), data analysis for compliance metrics
Preferred skills
Experience in GMP training management, technical writing, change control, deviations/investigation
Technologies
Microsoft Office (Outlook, Word, Excel), SharePoint, Learning Management Systems (LMS), Electronic Document Management Systems (EDMS), MS Teams
Responsibilities
Support documentation and training management for GMP laboratories, manage daily service requests in LMS, create and maintain training curricula, manage training impact assessments for SOPs, support documentation compliance for audits and inspections, calculate and communicate training compliance metrics
Seniority
Mid-level, hands-on IC
