Associate, Patient Materials Operation - Quad

Position Title: Associate, Patient Materials Operation

Direct Manager: Supervisor, Sample Management Division: CTDO Quality Control Duration: 06 Months Location: Summit West, S-12, 07901

Shifts:

• Associate Patient Material Operations
  - Thu
  - Sat and alt wed | 05:00 PM - 05:30 AM

The Assistant Specialist, Sample Management, is responsible for the movement and control of QC samples and materials in support of the QC laboratories at the CAR T manufacturing facility in Summit, NJ. This includes, but is not limited to, management of liquid nitrogen tank inventory, sample collection and distribution, inventory control, chain of custody, sample tracking, and sample delivery.

• Experience with cold chain sample storage and transfer.
• Experience working in a GMP regulated environment.
• Ability to work in a classified cleanroom environment and follow all applicable gowning requirements and procedures.
• Ability to follow and apply global regulatory and GMP requirements.
• Ability to follow SOPs.
• Ability to work in a collaborative team environment.
• Ability to adapt and adjust to changing priorities and manage multiple assignments with challenging/conflicting deadlines.

• 2+ years of relevant work experience, preferably in a regulated/cGMP environment.
• An equivalent combination of education and experience may substitute.

• Test Samples and Reagents
  • Handling test samples throughout the sample lifecycle- receipt, storage, distribution, transfer, and disposal.
  • Maintaining sample tracking and chain of custody records in accordance with GMP requirements and written procedures.
  • Ensuring that obsolete or expired samples and materials are destroyed and disposed of according to written procedures.
  • Performing sample queries and periodic storage reports, as required.
  • Assisting management with investigations and deviations related to sample management.
  • Collaborating with other departments to identify and implement process efficiencies.
• Laboratory Inventory
  • Maintaining the inventory of laboratory supplies including reagents, media, consumables, etc.
  • Maintaining the reference standard inventory and distributing reference standards to functional groups upon request.
  • Ensuring that materials are appropriately labelled and traceable according to GMPs, regulatory requirements, and written procedures.
  • Assisting management with investigations and deviations related to laboratory inventory.
  • Maintaining 5S and FIFO principles, as appropriate.
• QC Materials Support
  • Maintaining metrics for the sample management group.
  • Facilitating cold chain transfers of samples, as required.
  • Collaborating with supply chain, warehouse, and lab services to ensure all QC laboratory supplies are adequately stocked.
• Performs other tasks as assigned.

• The incumbent should be able to distinguish colors and possess correctable vision to 20/20.
• The incumbent will be doing light to moderate lifting, carrying, or moving objects under 15-20 lbs.
• The incumbent will be working in a laboratory setting up to eight hours per day.
• The incumbent will be working around biohazardous materials, including chemical agents, up to eight hours per day.
• The incumbent may be exposed to fluctuating and/or extreme temperatures on occasion.