QC Engineer - Cell-Therapy

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, CAPAs, and change controls;
• Support audit and inspection responses, including deviation defense, and train new team members;
• Author or review departmental procedures and support manufacturing and QC testing of CAR-T products as needed;
• Apply lean manufacturing and six sigma principles for continuous improvement;
• Champion a patients-first and Right First Time mindset throughout all activities.

Requirements:
Required Qualifications:

• Bachelor’s degree in Science or Engineering;
• 3+ years of relevant experience in a regulated environment (e.g., GMP/cGMP);
• Experience conducting deviation investigations using root cause analysis tools;
• Experience managing CAPA processes, including defining corrective actions and verifying effectiveness;
• Hands-on experience using TrackWise and Veeva QMS;
• Experience working under global regulatory and cGMP requirements in a life sciences manufacturing or Quality Control context;
• Experience supporting health authority inspections (e.g., FDA) and responding to audit or inspection observations;
• Authorization to work in the United States.

Preferred Qualifications:

• Experience initiating and managing change controls, including coordinating impact assessments;
• Experience working in a biopharmaceutical manufacturing facility;
• Hands-on experience supporting CAR-T operations or CAR-T manufacturing/Quality Control.

Benefits:
Work schedule: 100% on-site. Monday - Friday, regular business hours

6-month contract with possible extension

Pay rate: $42.94 - $54.54/hr.

Health benefits, holiday pay, and 401(k) program

Employee referral bonus program

Opportunity to contribute to high-impact projects with a leading biopharma company