Analyst Quality Control

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•$65,000 - $104,650•Onsite

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 4:00pm - 2:00am through Sunday - Wednesday. 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 MedTech, 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. Learn more at https://www.jnj.com/. 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 4:00pm - 2:00am (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

employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). This position is eligible to participate in the Company’s long-term incentive program.
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