QC Investigation Support Specialist
About The Position
Johnson & Johnson Innovative Medicine, a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Investigation Support Specialist (CAR-T) in Raritan, NJ. This role is part of the #CAR-T team and focuses on ensuring high quality in cell therapy products. The specialist will investigate deviations to support Quality Control (QC) testing laboratories for cell therapy products used in clinical trials and commercial operations within a controlled GMP environment. The position involves completing and reviewing CAR-T manufacturing and testing nonconformance investigations, interviewing QC lab personnel, and providing quality input for laboratory investigation reports. The specialist will also apply strong technical writing skills for documentation, partner with functional-area and Quality Assurance teams for timely investigation completion and corrective/preventive actions, and conduct deviation risk assessments. The role requires a high degree of urgency in responding to departmental and cross-functional needs and adherence to safety policies, quality systems, and cGMP requirements.
Requirements
- Minimum of a Bachelor's or equivalent University Degree required
- Minimum two (2) years of relevant work experience
- Experience in a Quality Control Laboratory setting
- Knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA/EU guidance related to the QC laboratory
- Adhering to Good Documentation Practices (GDP) to ensure accurate, complete, and inspection-ready reports
- Proficient in performing technical writing (e.g., deviations, investigations, etc.)
- Excellent written and verbal communication skills
- Highly organized, with the ability to work effectively in a team environment with supervision.
Nice To Haves
- Detailed knowledge of cell therapy QC assays and related equipment
- Familiarity with QEM (quality event management) systems
- Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
- Experience speaking and interacting with inspectors
- Experience building and delivering presentations to cross-functional audiences
Responsibilities
- Complete and review CAR-T manufacturing and testing nonconformance investigations.
- Interview QC lab personnel and provide quality input to support completion of laboratory investigation reports.
- Apply strong technical writing skills to draft clear, concise deviation and investigation documentation.
- Partner with functional-area and Quality Assurance teams to ensure timely investigation completion and implementation of effective corrective and preventive actions within QC laboratories.
- Conduct deviation risk assessments by collaborating cross-functionally with key stakeholders.
- Respond with a high degree of urgency to departmental and cross-functional needs and requests.
- Perform all tasks in accordance with safety policies, quality systems, and cGMP requirements.
Benefits
- Consolidated retirement plan (pension)
- Savings plan (401(k))
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Number of Employees
5,001-10,000 employees
