Johnson & Johnson Careers
QC Specialist Equipment and Sample Management, CAR-T
Raritan, New Jersey
Requisition ID: 9785190820
Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for a QC Specialist Equipment and Sample Management, 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
The QC Specialist Lab services is responsible for equipment lifecycle management, sample management, and QC systems administration. The QC specialist is expected 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 complex issues. He/ She will serve as technical expert within job function. Thinks analytically and acts decisively.
Additional Responsibilities Include:
• Assesses data. Prepares and reviews documentation independently.
• Ensure accuracy and completeness of executed analytical method qualification, validation, and transfer activities
• Skilled in all basic and advanced analytical methodologies within the functional laboratory
• Knowledge and understanding of current Good Manufacturing Practices (cGMP) related to the QC laboratory and ability to identify gaps in processes or systems
• Proficient in performing technical writing
• Ability to read and interpret documents such as SOPs, work instructions, test methods and protocols
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint), LIMS, iLAB
Support any combination of the following
• Sample management (internal and external shipments)
• Retains inspections and discards
• Document and perform non-conformance investigations
• Document and manage corrective and preventative action records
• Equipment Lifecycle Management (i.e change control)
• Manage equipment qualifications
• A Bachelors degree with a minimum of four (4) years related experience in medical device, biopharmaceutical or pharmaceutical industry or a Master Degree with a minimum two (2) years of experience in a related field or an advanced degree (Ph.D.) in a related field is required.
• A degree in Biology, Biochemistry, Microbiology Chemistry or related field is preferred.
• Working knowledge of regulatory requirements, policies and guidelines is preferred.
• Experience with Quality Control document reviews and regulatory inspection processes is preferred
• Working knowledge of Quality systems is preferred
• Proficient with using Microsoft Office applications (Outlook, Excel, Word, and Powerpoint), IMS, iLAB is required
• This position will occasionally require to lift up to 20 pounds.
• Candidates must be able to accommodate shift schedule. Shifts include routine weekend and evening work as required by the manufacturing process.
• Candidates must be able to accommodate unplanned overtime (including nights and weekends) on little to no prior notice.
• This position will be located in Raritan, NJ and may require up to 5% 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.
United States-New Jersey-Raritan-
Janssen Pharmaceuticals, Inc. (6062)