Analyst Quality Control, Analytics

Analyst, Quality Control Analytics – Raritan, NJ Shift: Wednesday–Saturday 2:00 pm–12:00 am. Janssen Pharmaceuticals, Inc., a member of Johnson & Johnson's Family of Companies, is recruiting for this position. The role involves working in a cGMP cleanroom environment to perform QC testing on autologous CAR‑T products for clinical trials and commercial operations. Key Responsibilities: Ensure testing is completed in compliance with all applicable procedures, standards, and current Good Manufacturing Practices regulations. Conduct analytical testing of raw material/utility, in-process, or final product samples submitted to the QC laboratories. Work with Process Development team, Quality, and Operations organization to successfully transfer process/analytical testing to cGMP facility to manufacture products. Perform peer review/approval of laboratory data. Use electronic systems (LIMS, iLAB) for execution and documentation of testing. Build, review, and approve relevant QC documents, SOPs, and WIs. Qualifications Education: Minimum of a Bachelor’s or equivalent University Degree; focused degree in Biology, Biochemistry, Microbiology, or related scientific field is preferred. Required Experience and Skills: Minimum 2 years of relevant work experience Knowledge and understanding of current Good Manufacturing Practices (cGMP) and Good Documentation Practices (GDP) Experience performing one or more of the following cellular and/or molecular based techniques: qPCR, ELISA, Cell Culture, and/or Potency assays Experience with Manual Sample Processing Excellent written and verbal communication skills Preferred Experience: Experience in a Quality Control setting Experience within Biopharmaceutical or Pharmaceutical industry Work experience in Cell and/or Gene Therapy or Biologics Experience with LIMs and SAP or equivalent systems Other Requirements: Requires ability and flexibility to work 10‑hour second shift (2PM - 12AM Weds‑Sat) Requires the ability to meet the physical demands (lift up to 20 lbs, stand or sit for extended periods of time in a laboratory setting), to perform visual inspections of materials (color, appearance, particles, etc.), and to document observations during laboratory testing Requires up to 5% domestic travel to other sites/locations The anticipated base pay range for this position is $61,000 to $110,000 USD. Compensation: Salary range: $61,000 to $110,000 USD. Benefits Vacation – 120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado – 48 hours per calendar year; for employees who reside in the State of Washington – 56 hours per calendar year Holiday pay, including Floating Holidays – 13 days per calendar year Work, Personal and Family Time - up to 40 hours per calendar year Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year Caregiver Leave – 80 hours in a 52‑week rolling period (10 days) Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year EEO Statement: 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 characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via internal employees contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr Johnson & Johnson Innovative Medicine