Analyst Quality Control, Analytics

Johnson & Johnson Innovative Medicine•Raritan, NJ

1d•$66,000 - $106,950•Onsite

About The Position

Johnson & Johnson Innovative Medicine is recruiting an Analyst, Quality Control Analytics - CAR-T in Raritan, New Jersey. The position performs biochemical, microbiological, and/or general testing of final product samples submitted to Quality Control laboratories. The analyst ensures testing is completed in accordance with applicable procedures, standards, and GMP regulations, and works with a team of 5–15 analysts in a functional QC laboratory. The role is scheduled for 10-hour shifts from 8:00 a.m. to 6:00 p.m., Sunday through Wednesday, with occasional support on weekends or other shifts. It requires laboratory work, the ability to lift up to 20 pounds, and the ability to stand or sit for extended periods. The analyst must also perform visual inspections of materials and document observations during testing. Up to 5% domestic travel to other sites or locations may be required.

Requirements

Bachelor’s degree or equivalent university degree.
At least two years of relevant work experience.
Experience performing one or more cellular or molecular techniques, such as qPCR, flow cytometry, ELISA, cell culture, or potency assays.
Experience in the biopharmaceutical or pharmaceutical industry.
Experience with aseptic processing in biosafety cabinets and/or an ISO 5 clean room.
Demonstrated experience working in an analyst-level role and proficiency using analytical methodologies in a functional laboratory.
Knowledge of cGMP regulations and Good Documentation Practices (GDP).
Experience with Quality Control document reviews and regulatory inspection processes.
Proficiency in technical writing, such as test methods, SOPs, and protocols.
Excellent written and verbal communication skills.
Ability and flexibility to work 10-hour shifts between 8:00 a.m. and 6:00 p.m., Sunday through Wednesday, and provide occasional support on weekends or other shifts.
Ability to lift up to 20 pounds, stand or sit for extended periods in a laboratory setting, visually inspect materials, and document testing observations.
Ability to travel domestically up to 5%.

Nice To Haves

Advanced degree (MSc. or Ph.D.) or a focused degree in Biology, Biochemistry, Chemistry, or a related scientific field.
Work experience in Cell and/or Gene Therapy or Biologics.
Basic knowledge of compendial requirements and standards, such as USP, EP, or JP.
Experience with LIMS and SAP or equivalent systems.
Experience, training, or certification with Process Excellence tools and methodologies.

Responsibilities

Perform analytical testing while maintaining a safe work environment and complying with applicable procedures, EHS requirements, and GMP regulations.
Perform peer review and approval of laboratory data and logbooks.
Use electronic systems such as LIMS and iLAB to execute and document testing.
Build, review, and approve relevant QC documents, SOPs, and work instructions.
Complete invalid assay and general laboratory investigation records, CAPAs, and change controls.
Support Health Authority inspections.
Provide input to functional laboratory meetings.

Benefits

Company consolidated retirement plan (pension) and savings plan (401(k)), subject to plan terms.
Vacation: 120 hours per calendar year.
Sick time: 40 hours per calendar year, with specified higher amounts for employees residing in Colorado or Washington.
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, or foster care of a child.
Bereavement Leave: 240 hours for an immediate family member and 40 hours for an extended family member per calendar year.
Caregiver Leave: 80 hours in a 52-week rolling period.
Volunteer Leave: 32 hours per calendar year.
Military Spouse Time-Off: 80 hours per calendar year.