QC Investigation Support Specialist

Johnson & Johnson•Raritan, NJ

2d•Onsite

About The Position

The QC Investigation Support Specialist will investigate deviations to support the Quality Control (QC) testing laboratories for cell therapy products used in clinical trials and commercial operations within a controlled GMP environment. This role is part of the Johnson & Johnson Innovative Medicine team, specifically the #CAR-T team, and is crucial for ensuring high quality in cell therapy products. The position is located in Raritan, NJ.

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