Car-T Qa Associate Ii

Janssen Pharmaceuticals Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Quality Assurance Associate II (QPIP), CAR-T Manufacturing in Raritan, NJ!

At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are working to create a world without disease. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease inspires us. We bring together the best minds and pursue the most promising science. We are Janssen. We collaborate with the world for the health of everyone in it. Learn more at www.janssen.com and follow us @JanssenGlobal. Janssen Biotech, Inc. is part of the Janssen Pharmaceutical Companies.

Janssen Biotech, Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, and Legend Biotech USA Inc., have entered into a global, strategic collaboration to develop, manufacture, and commercialize a chimeric antigen receptor (CAR) T-cell therapy. This innovative strategic partnership is designed to combine the strengths and expertise of two companies to advance the promise of an immunotherapy CAR-T platform and investigational treatment.

Are you interested in joining a team that is positively impacting patients' lives by ensuring high quality in our pharmaceutical products? Apply today for this exciting opportunity!

The QA Associate II is a Quality Person in the Plant (QPIP) and is responsible for on the floor quality oversight of the production of autologous CAR-T products for clinical trials and commercial operation in a controlled cGMP cleanroom environment.

Key Responsibilities:

• Other duties will be assigned, as the need arises.
• Provide Oversight and Support to clean room activities.
• Organization of Document Control room and preparation of completed Batch Records documents retransfers QA Document Control and Archival
• Support material release in SAP for In-house reagents.
• Support on process aseptic process simulations of the processes to ensure sterility of the product/process is not compromised.
• Real time review of all documentation and reporting in support of process unit operations.
• Support the Shop Floor Order QPIP review and Closure process for executed batches and In House reagents/intermediates.
• Provider QA shop floor support (Grad-B/ISO-7) for extended periods of time.
• Responsibilities will include but not limited to tasks mentioned above.
• Support drafting of standard operating procedures and batch records.
• Strive to reduce non-conformances in supported areas by proactively driving compliance.
• Perform tasks in a manner consistent with the safety policies, quality systems and cGMP requirements.
• Monitor warehouse, manufacturing, and support activities for cGMP compliance through spot checks/internal audits.
• Ensure non-conformances are investigated thoroughly and approved in a timely manner and appropriate corrective and preventive action plans are implemented.
• Approve printed documents prior to use on the manufacturing floor.
• Work with Process Development team and Operations organization to successfully transfer process to cGMP facility to manufacture products.

Qualifications

Education:

• Minimum of a bachelor’s or equivalent University Degree required; focused degree preferred in Science, Biology/Biotechnology, Cell/Gene Therapy, or equivalent technical field.

Experience:

Required:

• Minimum 2 years of relevant work experience.
• Knowledge and solid understanding of current Good Manufacturing Practices (cGMP) regulations and FDA/EU guidelines.
• Quality Assurance experience within pharmaceutical or a related industry.
• Strong interpersonal skills, positive mentality, and capability of working in a collaborative team environment.
• Proficient verbal communication skills, with the ability to optimally summarize and present results.
• Highly organized, with demonstrated attention to detail and ability to follow the procedures with minimal direction.

Preferred:

• Ability to collaborate well with stakeholders, customers, and peers.
• Ability to manage conflict and issues that arise with internal or external customers.
• Experience with aseptic processing in ISO 5 clean room.
• Familiarity with SAP, MES (electronic batch records), TrackWise (quality event management), or equivalent systems.
• Ability to summarize and present results, and experience with team-based collaborations is a must.
• Ability to handle multiple tasks on same time.
• Knowledge of cGMP regulations and FDA/EU guidance related to manufacturing of cell-based products as well as knowledge of Good Tissue Practices.
• Good written and verbal communication skills are required.

Other:

• Requires the ability to meet the physical demands (lift to 20 lbs. stand or sit for extended periods of time in a clean room environment), to perform visual inspections of materials (color, appearance, particles, etc.) and to document observations during manufacturing.
• Requires ability and flexibility to work 10-hour shifts between the operational hours of 7:30 AM – 6:00 PM Sunday-Wednesday, and provide occasional support including nights, weekends, or other shifts with little or no prior notice
• The anticipated range for this position is $60,000 to $87,500
• This position will require up to 10% of travel

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 .

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