Manufacturing Compliance Specialist
Core
Conduct investigations into manufacturing deviations, identify root causes, and manage corrective and preventative actions (CAPA) to ensure compliance with GMP standards.
Role type
Manufacturing Compliance Specialist
Builds
Investigation reports, CAPA implementation plans, and status tracking for open deviations.
Domain
Pharmaceutical manufacturing / Quality Engineering
Required skills
Root cause analysis, GMP knowledge, technical writing, project management, cross-functional facilitation, impact analysis, ERP system proficiency
Preferred skills
None stated
Technologies
Word, Excel, ERP systems
Responsibilities
Conduct investigations for deviations, identify root causes, write and review investigation reports, facilitate deviation huddles, project manage CAPA implementation, maintain lists of open investigations.
Seniority
Mid-level, hands-on IC