Quality Control Analyst, Critical Reagants

Johnson & Johnson seeks a Quality Control Analyst to conduct analytical testing and qualification of critical reagents for CAR-T cell therapy manufacturing. The role involves ensuring compliance with GMP regulations, documentation, and cross-functional support in a Raritan, New Jersey laboratory setting.

Responsibilities

• Conduct analytical testing to qualify critical reagents used in CAR-T QC laboratories
• Perform testing in compliance with applicable procedures, GMP, and GDP regulations
• Document execution of testing using eLIMS or paper records
• Prepare qualification documentation and issue Certificates of Analysis
• Author and update SOPs, work instructions, and protocols in the Document Management System

Requirements

• Bachelor's degree in Biology, Biochemistry, or related scientific field
• Minimum two years of relevant work experience
• Knowledge of cGMP regulations and Good Documentation Practices
• Experience with qPCR, Flow Cytometry, ELISA, Cell Culture, or Potency assays
• Excellent written and verbal communication skills
• Preferred: Reagent qualification or Quality Control experience
• Preferred: Biopharmaceutical or pharmaceutical industry background

Compensation: $65,000–$104,650 base