Senior Specialist, Quality Assurance Investigations, Cell Therapy, Devens - MA
Core
Oversee and approve deviation investigations, CAPAs, and effectiveness checks for cell therapy manufacturing to ensure product quality and regulatory compliance.
Role type
Senior Quality Assurance Specialist (Cell Therapy Manufacturing)
Builds
Quality oversight and assurance of manufactured cell therapy products
Domain
Biopharmaceuticals / Cell Therapy Manufacturing
Required skills
Root cause analysis, regulatory guideline interpretation, CAPA management, technical report review, data analysis, cross-functional collaboration
Preferred skills
FDA/EMA regulations knowledge, electronic system proficiency, training delivery
Technologies
MS Office, Smartsheets
Responsibilities
Review and approve investigations/CAPAs/effectiveness checks; Author and review technical reports (risk assessments, deviation monitoring); Ensure corrective/preventive actions address root causes; Perform routine reporting and analysis of quality metrics; Support internal and external inspections; Lead cross-functional meetings and share data/knowledge
Seniority
Senior, hands-on IC
