Scientist/Engineer - QC Deviation Management

SOKOL GxP Services • Summit, NJ

8d • $43 - $55 • Onsite

About The Position

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.

Requirements

• 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

Nice To Haves

• 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

Responsibilities

• 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

Benefits

• Health benefits
• Holiday pay
• 401(k) program
• Employee referral bonus program
• Opportunity to contribute to high-impact projects with a leading biopharma company

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level