QC Investigation Support Specialist

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world.  We provide an inclusive work environment where each person is considered as an individual.  At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Quality

Job Sub Function:

Quality Assurance

Job Category:

Professional

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description:

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!

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity. Learn more at www.jnj.com/.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our cell therapy products? Apply today for this exciting opportunity to be part of the #CAR-T team!

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.

Key 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.

Qualifications:

Education:

Minimum of a Bachelor's or equivalent University Degree required

Experience and Skills:

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.

Preferred:

• 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

Other:

• Requires ability and flexibility to accommodate shift schedule (if needed) and unplanned overtime (including nights and weekends) on little to no prior notice
• Requires up to 10% of domestic travel

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.
Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation,  external applicants please contact us via https://www.jnj.com/contact-us/careers . internal employees contact AskGS to be directed to your accommodation resource.
#CAR-T

Required Skills:

 

 

Preferred Skills:

 

 

The anticipated base pay range for this position is :

$65,000.00 - $104,650.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).

Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:

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 period10 days

Volunteer Leave – 32 hours per calendar year

Military Spouse Time-Off – 80 hours per calendar year