Specialist, QC Analytical

Bristol Myers Squibb•Summit, NJ
•$35 - $42•Onsite

About The Position

The Specialist, QC Analytical performs routine testing of in-process, final product, and stability samples in accordance with Bristol Myers Squibb policies, standards, procedures, Global Regulatory requirements, and cGMP requirements. The role supports the Quality Control Analytical department at BMS’s CAR T Manufacturing facility in Summit, New Jersey. It may also support method transfer, validation, and verification testing, document revisions, and investigation-related tasks. The position is scheduled Wednesday through Saturday, 1:30 p.m. to 11:30 p.m. It involves laboratory work, including frequent pipetting and tasks within a biological safety cabinet, use of required PPE, and handling materials and chemicals that may include liquid nitrogen and other cryogenically cooled materials.

Requirements

  • Bachelor’s degree or equivalent required; preferably in a science field.
  • At least 2 years of relevant analytical testing or QC experience, or an equivalent combination of education and experience; preferably in a regulated environment.
  • Demonstrated experience with cell and molecular biology techniques, such as cell-based assays, flow cytometry, qPCR, ELISA, and aseptic technique.
  • Ability to accurately and completely understand, follow, interpret, and apply Global Regulatory and cGMP requirements.
  • Problem-solving ability; technically adept and logical.
  • Ability to communicate effectively with peers, department management, and cross-functional peers.
  • Ability to work in a fast-paced team environment, meet deadlines, and prioritize work.
  • Ability to lift up to 45 lbs at floor and waist height (commonly under 20 lbs), lift up to 10 lbs overhead, and push or maneuver carts to transport materials.
  • Ability to operate and handle scissor lift carts requiring 15–20 lbs of initiation force.
  • Ability to perform frequent pipetting and laboratory tasks within a biological safety cabinet, including prolonged seated work.
  • Ability to independently don, doff, and wear required PPE during the work shift, including cryogenic gloves as needed.
  • Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals.
  • Ability to use step stools to reach and handle materials.

Nice To Haves

  • Knowledge of LIMS, ELN, and laboratory data analysis systems.
  • Experience writing technical documents.
  • Relevant analytical testing or QC experience in a regulated environment.
  • A bachelor’s degree in a science field.

Responsibilities

  • Perform routine testing of in-process, final product, and stability samples.
  • May perform testing for method transfer, validation, and verification.
  • Perform data verification and data review, and review GMP documentation for general methods.
  • May perform document revisions and project, CAPA, deviation, investigation-related, and continuous improvement tasks.
  • Train analysts on general job duties.
  • Perform other tasks as assigned.

Benefits

  • Wellbeing support, retirement and financial protection benefits, and medical, dental, vision, life, and disability insurance offerings, subject to plan terms and eligibility.
  • For non-exempt employees: 160 hours of paid vacation annually for new hires, subject to manager approval; 11 paid company holidays; and 3 optional holidays.
  • Depending on eligibility: paid sick leave, up to two paid volunteer days per year, summer hours flexibility, and leaves of absence for medical, personal, parental, caregiver, bereavement, or military needs.
  • Eligible employees may receive an annual Global Shutdown between Christmas Day and New Year’s Day.
  • Additional discretionary incentive cash and stock opportunities may be available.
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