QA/QMS Senior Specialist — Deviations & Investigations
Core
Lead deviation management and root cause analysis for sterile GMP manufacturing operations to ensure regulatory compliance and product quality.
Role type
Senior IC Quality Assurance Specialist (Deviations & Investigations)
Builds
FDA-compliant sterile pharmaceutical products
Domain
Pharmaceutical manufacturing (Sterile GMP)
Required skills
Root cause analysis (Ishikawa, 5-Why, fault tree), sterile manufacturing deviation investigation, technical writing, TrackWise/Veeva QMS, batch disposition coordination, regulatory compliance (21 CFR 210/211/212), data integrity (ALCOA+)
Preferred skills
FDA inspection support, CAPA and Change Control processes
Technologies
TrackWise, Veeva QMS
Responsibilities
Own deviation lifecycle from initiation to closure, conduct root cause analyses, author investigation narratives and reports, classify deviations by severity, coordinate batch disposition, track deviation KPIs, support internal audits and FDA inspections.
Seniority
Senior, hands-on IC
