Senior Specialist, QA Operations Investigations
Core
Review and approve manufacturing and laboratory investigations, CAPAs, and effectiveness checks to ensure product quality and regulatory compliance.
Role type
Senior Specialist, QA Operations Investigations
Builds
Quality oversight for manufactured products in compliance with cGMP and regulations
Domain
Biopharmaceuticals / Cell therapy manufacturing
Required skills
Root cause analysis (5-WHY, Fishbone, Process Flow), CAPA management, regulatory guideline interpretation, data analysis, technical writing, risk assessment
Preferred skills
FDA/EMA regulations knowledge, electronic system/database experience, cross-functional collaboration
Technologies
MS Office, Smartsheets
Responsibilities
Review and approve investigations/CAPAs/effectiveness checks; Author and review technical reports (risk assessments, deviation monitoring); Ensure CAPAs address root cause; Perform routine reporting and analysis of metrics; Support internal and external inspections; Lead meetings and represent function at cross-functional meetings
Seniority
Senior, hands-on IC