Investigation Specialist I
Core
Lead GMP investigations for manufacturing deviations, product quality excursions, and compliance events to ensure patient access to medicines.
Role type
Senior IC quality investigation specialist (GMP manufacturing)
Builds
Quality systems, manufacturing robustness, and regulatory compliance
Domain
Pharmaceutical manufacturing / Biotechnology
Required skills
GMP biotechnology manufacturing experience, technical writing, data analysis, root cause analysis, project management, cross-functional collaboration
Preferred skills
AI tool usage (ChatGPT, Copilot), biologics manufacturing knowledge, quality risk management tools (Fishbone, 5-Why, FMEA), regulatory inspection support
Technologies
DeltaV, SAP, Microsoft Dynamics, LIMS, electronic batch records, document management systems, data historian platforms
Responsibilities
Lead and author GMP investigations for deviations and quality excursions; Conduct fact-finding and technical assessments using manufacturing and lab data; Facilitate cross-functional teams to identify root causes; Partner with Manufacturing, QA, Engineering, and Validation teams; Drive investigations to completion ensuring regulatory compliance; Evaluate trends to support continuous improvement; Support internal/external audits and regulatory inspections.
Seniority
Entry-level to Mid-level (0-2 years exp with Bachelor's or 4-6 years with Associate's/High School)