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Specialist III, QC Investigation Support (CAR-T)
Company: Johnson & Johnson
Location: Raritan, NJ
Employment Type: Full Time
Date Posted: 06/18/2022
Expire Date: 10/05/2022
Job Categories: Biotechnology and Pharmaceutical, Finance/Economics, Healthcare, Other, Information Technology, Manufacturing and Production, Quality Control, Research & Development, Medical, Writing/Authoring
Job Description
Specialist III, QC Investigation Support (CAR-T)

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a Specialist III, QC Investigation Support (CAR-T)!

 

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 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.

Qualifications

Education:

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

Experience and Skills:

Required:

  • Minimum 4 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 and awareness of compendial (USP, EP, JP, etc.) requirements pertaining to the functional area of QC
  • Proficient in performing technical writing (e.g., deviations, investigations, etc.)
  • Excellent written and verbal communication skills
  • Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint)
  • 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 Trackwise (quality event management) or equivalent systems
  • Experience speaking and interacting with inspectors
  • Experience with aseptic processing in ISO 5 clean room and/or biosafety cabinets
  • 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

 

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

 

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.


Primary Location
United States-New Jersey-Raritan-1000 US HIghway 202
Organization
Janssen Pharmaceuticals, Inc. (6062)
Job Function
Quality
Requisition ID
2206045904W
Contact Information
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