Specialist, QC Analytical Cell Therapy - Summit West NJ

Military Spouse Corporate Career Network • Summit West, NJ

3d • Onsite

About The Position

This role supports quality control (QC) testing for in-process, final product, and stability samples, including data review and verification. The specialist may also assist with method transfer, documentation, deviations, investigations, and continuous improvement efforts. The position is onsite at Summit West, New Jersey, and works Wednesday through Saturday, 1:30 p.m. to 11:30 p.m.

Requirements

• Bachelor's degree or equivalent; preferably in science.
• 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 understand, follow, interpret, and apply global regulatory and cGMP requirements.
• Problem-solving ability, technical aptitude, and logical thinking.
• 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 and up to 10 lbs (4.5 kg) overhead, and to push or maneuver carts.
• Ability to perform frequent pipetting and related laboratory tasks within a biological safety cabinet, including extended seated work.
• Ability to independently don, doff, and wear required PPE for prolonged periods while performing laboratory work.
• Ability to safely handle chemical disinfectants, flammable materials, and hazardous chemicals; work may involve dry ice, liquid nitrogen, and cryogenically cooled materials.
• Ability 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.
• 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.
• Verify and review data and review GMP documentation for general methods.
• Perform document revision, project, CAPA, deviation, and investigation-related tasks and continuous improvement efforts as needed.
• Train analysts on general job duties.
• Perform other tasks as assigned.
• Perform laboratory 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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level