Investigation Specialist I
Core
Lead GMP investigations for manufacturing deviations, product quality excursions, and compliance events to ensure patient access to medicines.
Role type
Junior IC quality investigation specialist (GMP manufacturing)
Builds
Quality systems compliance and manufacturing robustness
Domain
Pharmaceutical manufacturing / Biotechnology
Deliverable
production ML models | product features | dashboards & analysis | research | client delivery | infrastructure | physical/clinical work
Required skills
GMP biotechnology manufacturing experience, technical writing, data analysis, root cause analysis, project management, regulatory compliance knowledge
Preferred skills
Biologics manufacturing processes (cell culture, purification), quality risk management tools (Fishbone, 5-Why, FMEA), manufacturing systems (DeltaV, SAP, LIMS), AI tool usage
Responsibilities
Lead and author GMP investigations for deviations and quality excursions, conduct fact-finding and technical assessments, facilitate cross-functional teams to identify root causes, partner with engineering and QA to determine product disposition, drive investigations to completion with regulatory compliance, evaluate trends for continuous improvement, support internal and external audits
Seniority
Junior, hands-on IC
