Analyst Quality Control
About The Position
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 going to be 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! The QC Analyst is responsible for conducting biochemical, microbiological, and/or general testing of final product samples submitted to the QC laboratories. They are responsible for ensuring testing is completed in compliance with all applicable procedures, standards, and GMP regulations. They typically work with a team of 5 – 15 other Analysts within the functional laboratory of the Quality Control department.
Requirements
- 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
- 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 within 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, SOP's, protocols, etc.)
- Excellent written and verbal communication skills
- Requires ability and flexibility to work 10-hour shifts between the operational hours of 8:00am - 6:00pm (Sunday - Wednesday), and provide occasional support on the weekends or other shifts
- 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
Nice To Haves
- 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
Responsibilities
- 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
Benefits
- Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
- Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off 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 period10 days
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
