Specialist, QC Analytical

Quality Control Analytical Specialist performs routine testing of in-process, final product, and stability samples in a CAR T manufacturing facility. The role supports method validation, data verification, and GMP documentation review while adhering to regulatory standards.

Responsibilities

• Conduct routine testing of in-process, final product, and stability samples
• Perform data verification and review of GMP documentation for general methods
• Support method transfer, validation, and verification activities as needed
• Assist with document revisions, investigations, deviations, and continuous improvement efforts
• Train analysts on general job duties and laboratory procedures

Requirements

• Bachelor's degree in science or equivalent
• 2+ years analytical testing or QC experience in regulated environment
• Demonstrated cell and molecular biology techniques experience
• Knowledge of LIMS, ELN, and laboratory data analysis systems preferred
• Ability to follow and interpret cGMP and regulatory requirements
• Strong problem-solving and technical aptitude
• Effective communication with cross-functional teams

Compensation: $34.82 - $42.19 per hour