Deviation Supervisor - Onsite Greenville, NC
Core
Lead investigations and root cause analysis for deviations in a high-volume sterile pharmaceutical manufacturing facility to ensure compliance and product safety.
Role type
Deviation Supervisor (Quality & Compliance)
Builds
Investigation reports, CAPA plans, and process improvement initiatives for sterile manufacturing operations.
Domain
Pharmaceutical manufacturing / Quality Assurance / Regulatory Compliance
Deliverable
client delivery
Required skills
Root cause analysis (6M, Fishbone, TapRooT), statistical analysis, technical writing, risk assessment, project management, GMP compliance knowledge, data collection, team leadership, conflict resolution.
Preferred skills
Track Wise proficiency, adult learning methodologies, continuous improvement project experience.
Technologies
Track Wise, TapRooT, Microsoft Suite (Word, Excel, PowerPoint)
Responsibilities
Lead structured investigations and data collection; identify root causes and develop CAPA; assess quality impact against regulatory guidelines; compile KPIs; present findings to review boards and customers; mentor staff; provide oversight of investigation completion.
Seniority
Mid-Senior, hands-on IC with team leadership