Deviation Investigator - Greenville, NC
Core
Investigate, document, and resolve manufacturing deviations in sterile pharmaceutical operations to ensure compliance with cGMP and regulatory requirements.
Role type
Deviation Investigator (Quality Assurance)
Builds
Investigation reports, root cause analyses, and corrective action documentation for sterile manufacturing.
Domain
Pharmaceutical manufacturing / Quality Assurance / cGMP
Required skills
Technical writing, Root cause analysis, cGMP knowledge, Data integrity (ALCOA+), Cross-functional collaboration, Attention to detail, Evidence gathering, Regulatory compliance, Report writing, Interviewing
Preferred skills
Sterile manufacturing experience, TrackWise QMS, Aseptic processing knowledge, CAPA documentation, 5-Why/Fishbone analysis
Technologies
Global TrackWise, Electronic batch records, Manufacturing execution systems
