QC Investigation Support Specialist (1 of 5) - Johnson and Johnson

Janssen Pharmaceuticals, Inc., 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 https://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 Specialist will be responsible for leading deviations and corrective actions in support of the Quality Control (QC) testing laboratories related to the manufacturing of cell therapy products for clinical trials and commercial operations in a controlled GMP environment.
Key Responsibilities:

• Interview personnel within QC and provide quality insight to complete laboratory investigation reports in Trackwise.
• Review/complete routine CAR-T manufacturing nonconformance/deviation investigations.
• Proactively work with team members to implement effective corrective and preventive actions (CAPAs) and to ensure the timely completion of CAPAs within the laboratories.
• Provide recommendations for the improvement of processes by working cross-functionally with multiple collaborators.
• Work closely with management to propose/execute improvements through the change management system.
• Ability to respond with a high degree of urgency to departmental and cross-functional needs and requests.
• Report/monitor metrics on non-conformance investigations and CAPAs.
• Perform tasks in a manner consistent with the safety policies, quality systems, and cGMP requirements.

Education:

• Minimum of a Bachelor's or equivalent University Degree required

Experience and Skills:

Requird:

• Minimum two (2) years of relevant work experience
• Experience in a Quality Control setting
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) and FDA/EU guidance related to the QC laboratory
• Knowledge of Good Documentation Practices (GDP)
• Proficient in performing technical writing (e.g., deviations, investigations, etc.)
• Excellent written and verbal communication skills
• Highly organized and capable of working in a team environment under some supervision

Preferred:

• Detailed knowledge of CAR-T QC test methods and related equipment
• Familiarity with QEM (quality event management) or equivalent systems
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Experience speaking and interacting with inspectors
• Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
• Knowledge of Good Tissue Practices

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
• The anticipated base pay range for this position is $61,000 to $97,750.
• Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance.
• Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
• Employees are eligible for the following time off benefits:
• Vacation - up to 120 hours per calendar year
• Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year
• Holiday pay, including Floating Holidays - up to 13 days per calendar year
• Work, Personal and Family Time - up to 40 hours per calendar year

Johnson & Johnson is an Affirmative Action and 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, or protected veteran status and will not be discriminated against on the basis of disability.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com .

#CAR-T