Associate Specialist, Value Stream Cryo Operations - Summit West, NJ

About the role

The Specialist, Value Steam Cryo Operations is responsible for the Cryopreservation, movement, storage, control of manufacturing patient materials, and support of Liquid Nitrogen storage tanks and equipment at the CAR T manufacturing facility in Summit, NJ.

Responsibilities

• Handling patient material throughout the material Cryopreservation, 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.
• Maintaining metrics for the Value Stream Cryo Operations group.
• Facilitating cold chain transfers of material, as required.
• Supporting manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintaining timing according to the production schedule to ensure on-time logistics.
• Able to problem solve with minimal supervision.
• Works in a team-based, cross-functional environment to complete tasks required by shift schedule.

Requirements

• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• General understanding of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Background to include an understanding of biology, chemistry, medical or clinical practices.
• Available to work OT when business requires.
• Willing to work staggered day shift hours.

Skills

• Knowledge of cGMPs.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.
• Understanding of biology, chemistry, medical or clinical practices.

Benefits

At Bristol Myers Squibb, we offer a wide variety of competitive benefits, services and programs that provide our employees with the resources to pursue their goals, both at work and in their personal lives.

Pay

$34.66 - $42.00 per hour

Schedule

Shift Available Sunday - Wednesday (with e/o Wednesday off), Onsite Night Shift, 5 p.m. - 5:30 a.m.