Quality Control Specialist, Lab Services-Car-T

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies is recruiting for a Quality Control Specialist, Lab Services-CAR-T! This position will be located 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 Pharmaceuticals, LLC is part of the Janssen Pharmaceutical Companies.

The QC Specialist, Lab Services, is responsible for sample management. The QC Specialist is encouraged to work independently on routine tasks and have conceptual understanding of all Quality Control functions and business areas. May need supervision/support to resolve some sophisticated issues. He/ She will serve as technical specialist within job function. Thinks logically and acts decisively.

Are you interested in joining a diverse team delivering outstanding results to our customers? Apply now for this exciting opportunity!

Key Responsibilities:

• Periodic inspection and consolidation of retains
• Prepare documents and coordinate Sample shipment (internal and external shipments)
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and PowerPoint) and lab management software system (LIMS)
• Review logbooks and/ or LIMs to align physical quantities of samples in freezers
• Supports internal and regulatory audits
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems
• Responsible for QC sample and retain management
• Document and handle corrective and preventative action records
• Prepares and reviews documentation independently.
• Document and perform sample management related non-conformance investigations

Qualifications

Education :

A minimum of a Bachelor's or equivalent University degree is required, with a focused degree in Biology, Biochemistry, Microbiology, Chemistry or related field preferred.

Required:

• A minimum of two (2) years related experience in medical device, biopharmaceutical, or pharmaceutical industry
• Candidates must be able to accommodate shift schedule. Shifts include weekend and evening work as required by the manufacturing process

Preferred:

• Solid understanding of regulatory requirements, policies and guidelines
• Experience with Quality Control document reviews and regulatory inspection processes
• Working knowledge of Quality systems
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint), and LIMS

Other:

• This position may require up to 5% domestic travel.
• This position may occasionally require heavy lifting up to 20 pounds.

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.