Specialist, QC Analytical Cell Therapy - Summit West NJ
About The Position
Responsible for supporting quality control testing for in-process, final product, and stability samples, including data review and verification. The role may also assist with method transfer, documentation, deviations, investigations, and continuous improvement efforts. This is an on-site position at the location specified in the job post. The schedule is Wednesday through Saturday, 1:30 p.m. to 11:30 p.m. The position requires working in a laboratory environment, including a Biosafety Level 2 (BSL-2) environment, and following EHSS procedures and safety programs. The listed compensation for Summit West, New Jersey is $34.82–$42.19 per hour. A separate compensation overview lists a Field—United States range of $134,390–$162,843.
Requirements
- Bachelor's degree or equivalent required, preferably in science.
- At least 2 years of relevant analytical testing or QC experience, or an equivalent combination of education and experience; experience in a regulated environment is preferred.
- Demonstrated experience in 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 and a technically adept, logical approach.
- 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 20 lbs (9 kg) at floor and waist height; lift up to 10 lbs (4.5 kg) overhead; and push or maneuver carts to transport materials.
- Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended periods of seated work.
- Ability to independently don, doff, and wear required PPE, including lab coat or frock, gloves, and safety glasses or face shield, for prolonged periods.
- Ability to safely handle and use chemical disinfectants, flammable materials, and hazardous chemicals.
- Ability to work with dry ice, liquid nitrogen, and cryogenically cooled materials, and to use step stools while reaching and handling materials.
- Ability to work in a Biosafety Level 2 (BSL-2) environment.
Nice To Haves
- Knowledge of LIMS, ELN, and laboratory data analysis systems.
- Experience writing technical documents.
- Science degree field of study.
- Experience in a regulated environment.
Responsibilities
- Perform routine testing of in-process, final product, and stability samples.
- 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 tasks related to projects, CAPA, deviations, investigations, and continuous improvement efforts.
- Train analysts on general job duties.
- Perform other tasks as assigned.
- Perform work safely in accordance with EHSS procedures, including identifying and controlling risks, using PPE, safely handling chemicals and biological agents, complying with waste and emergency procedures, and participating in training and safety programs.
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
