QC Analytical Scientist
Core
Testing gene therapy products and associated materials to ensure compliance with EU and FDA GMP requirements.
Role type
QC Analytical Scientist
Builds
Gene therapy products and associated materials
Domain
Biologics / Gene Therapy
Required skills
GMP compliance, analytical testing, laboratory equipment operation and maintenance, SOP development, data integrity management, corrective action implementation, environmental monitoring support, audit support
Preferred skills
Knowledge of EU and FDA regulations, GMP/GLP/GCP, Lean Manufacturing, Six-Sigma, IT proficiency, Microsoft Office
Technologies
Laboratory equipment, Microsoft Office (Word, Excel, PowerPoint)
Responsibilities
Test gene therapy products per specifications, operate and maintain lab equipment, record out-of-specifications and non-conformances, assist in developing SOPs, support audits and inspections, maintain QC facilities and Quality Management System
Seniority
Mid-level, hands-on IC
