Senior Specialist, QA Investigations
Core
Quality oversight and approval of Deviation investigations and Action/Effectiveness Check records at a cell therapy manufacturing facility.
Role type
Senior Specialist, QA Investigations
Builds
Quality assurance of manufactured products in compliance with regulations
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
Deviation investigation, Root cause analysis (5-WHY, Fishbone), CAPA management, Regulatory compliance (FDA/EMA), Risk assessment, Data analysis, Technical writing
Preferred skills
Cell therapy manufacturing experience, FDA/EMA regulations knowledge, Electronic system/database proficiency
Responsibilities
Review and approve investigations/CAPAs/effectiveness checks, Review technical reports (risk assessments, monitoring reports), Ensure corrective/preventive actions 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