QC Engineer - Cell-Therapy

Job description

SOKOL GxP Services is seeking a Scientist/Engineer to join our client site in Summit, New Jersey, supporting CAR-T manufacturing and Quality Control operations. This role is integral to driving robust investigation processes, ensuring timely resolution of deviations, and maintaining the highest standards of compliance and product integrity. Key responsibilities include: - Lead manufacturing and Quality Control investigation reports supporting CAR-T operations; - Execute thorough root cause investigations, including interviewing personnel, hypothesis testing, and interpreting results; - Author detailed investigation reports and identify corrective and preventive actions (CAPA), verifying their effectiveness; - Troubleshoot complex problems and lead cross-functional investigation teams to ensure timely closure of reports; - Conduct investigations (OOS, OOT, environmental monitoring, deviations) using root cause analysis tools; - Perform GEMBA walks and propose CAPAs, developing comprehensive CAPA plans; - Assess impact and risk, develop mitigation strategies, and initiate change control documentation; - Coordinate impact assessments and provide technical support for investigations, C...