Analyst, Quality Control Analytics (2 openings)

Johnson & Johnson•Raritan, NJ

1d•Onsite

About The Position

Johnson & Johnson is recruiting two Quality Control Analysts for its CAR-T team in Raritan, New Jersey. The role supports the manufacture of autologous CAR-T products for clinical trials and commercial operations by completing quality control testing in a controlled cGMP cleanroom environment. The position works a 10-hour second shift, Wednesday through Saturday, from 2 p.m. to 12 a.m., and requires up to 5% domestic travel to other sites or locations.

Requirements

Bachelor’s degree or equivalent university degree.
At least 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 cellular or molecular techniques: qPCR, ELISA, cell culture, or potency assays.
Experience with manual sample processing.
Excellent written and verbal communication skills.
Ability and flexibility to work 10-hour shifts, Wednesday through Saturday, from 2 p.m. to 12 a.m.
Ability to lift up to 20 pounds, stand or sit for extended periods in a laboratory setting, visually inspect materials, and document laboratory observations.
Ability to travel domestically up to 5%.

Nice To Haves

A degree focused in Biology, Biochemistry, Microbiology, or a related scientific field.
Experience in a Quality Control setting.
Experience in the biopharmaceutical or pharmaceutical industry.
Work experience in cell or gene therapy or biologics.
Experience with LIMS and SAP or equivalent systems.

Responsibilities

Complete QC testing in compliance with applicable procedures, standards, and current Good Manufacturing Practices regulations.
Conduct analytical testing of raw material and utility, in-process, or final product samples submitted to QC laboratories.
Work with Process Development, Quality, and Operations teams to transfer processes and analytical testing to the cGMP facility.
Perform peer review and approval of laboratory data.
Use electronic systems, including LIMS and iLAB, to execute and document testing.
Build, review, and approve relevant QC documents, standard operating procedures, and work instructions.
Perform visual inspections of materials and document observations during laboratory testing.

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 different allocations 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.