Quality Assurance Specialist II (CAR-T)

Location: Raritan, New Jersey, United States of America; onsite. Full-time shift: Wednesday–Saturday or Sunday–Wednesday, 7:30 a.m.–6:00 p.m., with a preference for Wednesday–Saturday.

Salary: $65,000–$104,650 per year.

Company

Johnson & Johnson MedTech develops healthcare solutions, with this role supporting Janssen Biotech and a strategic CAR-T cell therapy collaboration.

What you will do

• Review manufacturing documentation released under Good Documentation Practices.
• Provide quality and compliance input to investigations, remediation, and continuous improvement initiatives.
• Review, revise, and draft quality-related Standard Operating Procedures.
• Support batch release processes and improve release turnaround times.
• Perform quality activities with minimal supervision while following established procedures.
• Drive compliance, reduce non-conformances, and maintain records ready for regulatory inspections and internal audits.

Requirements

• Bachelor’s degree in science, information science, or an equivalent technical discipline.
• At least 2 years of experience in quality assurance, quality systems, or compliance.
• Knowledge of cGMP, GTP, and FDA regulations.
• Experience with large-molecule or CAR-T production.
• Knowledge of international regulatory guidelines, including EU guidance.
• Ability to work onsite in Raritan, New Jersey, on the specified 7:30 a.m.–6:00 p.m. shift.

Culture & Benefits

• Cross-functional, team-based working environment.
• Retirement pension and 401(k) savings plans.
• Vacation, sick time, holiday pay, and work, personal, and family time.
• Parental, bereavement, caregiver, volunteer, and military spouse leave benefits.
• Inclusive workplace and interview accommodations for applicants with disabilities.