Analyst Quality Control

Overview

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 Med Tech, 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.

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Job Function: Quality

Job Sub Function: Quality Control

Job Category: Professional

All Job Posting Locations: Raritan, New Jersey, United States of America

Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for an Analyst, Quality Control Analytics - CAR-T in Raritan, NJ. This shift is scheduled 8:00am – 6:00pm Sunday–Wednesday.

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!

• Perform analytical testing and maintain a safe work environment in compliance with all applicable procedures, EHS, and GMP regulations
• Perform peer review/approval of laboratory data and logbooks
• Use electronic systems (e.g., LIMS, iLAB) for execution and documentation of testing
• Build, review, and approve relevant QC documents, SOPs, and WIs
• Complete invalid assay and general laboratory investigation records, CAPAs, change controls
• Support Health Authority inspections
• Provide input to functional laboratory meetings

Education

• Minimum of a Bachelor’s or equivalent University Degree required; advanced degree (MSc., Ph.D.) or focused degree in Biology, Biochemistry, Chemistry, or related scientific field is preferred

Experience and Skills

• Minimum of two (2) years of relevant work experience
• Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, Flow Cytometry, ELISA, Cell Culture, and/or Potency assays
• Experience with in Biopharmaceutical or Pharmaceutical industry
• Experience with aseptic processing in biosafety cabinets and/or ISO 5 clean room
• Demonstrated experience successfully working in an analyst role/level and proficiency using analytical methodologies within a functional laboratory
• Knowledge of cGMP regulations and Good Documentation Practices (GDP)
• Experience with Quality Control document reviews and regulatory inspection processes
• Proficient in performing technical writing (e.g., test methods, SOPs, protocols, etc.)
• Excellent written and verbal communication skills

• Work experience in Cell and/or Gene Therapy or Biologics
• Basic knowledge of Compendial (e.g., USP, EP, JP, etc.) requirements and standards
• Experience with LIMS and SAP or equivalent systems
• Experience, training, or certification with Process Excellence tools and methodologies

• Requires ability and flexibility to work 10-hour shifts between 8:00am – 6:00pm (Sunday - Wednesday), and provide occasional support on weekends or other shifts
• Requires the ability to meet physical demands (lift up to 20 lbs, stand or sit for extended periods in a laboratory setting), perform visual inspections of materials (color, appearance, particles, etc.), and document observations during laboratory testing
• Requires up to 5% domestic travel to other sites/locations

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Johnson & Johnson is an 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, disability, protected veteran status or other…