Job Description

Associate Specialist responsible for cryopreservation, storage, and inventory management of patient materials at a CAR T manufacturing facility in Summit, NJ. The role supports liquid nitrogen storage operations and ensures compliance with GMP requirements and chain of custody protocols.

Responsibilities

• Process, store, transfer, and dispose of patient materials following cryopreservation protocols and approved procedures.
• Maintain sample tracking, chain of custody records, and inventory control in compliance with GMP and GDP requirements.
• Support investigations, deviations, and corrective action activities related to cryopreservation and sample handling.
• Manage liquid nitrogen storage inventory and execute cryopreservation logistics aligned with production schedules.
• Collaborate cross-functionally to improve processes, resolve documentation errors, and support personnel training and readiness.

Requirements

• Bachelor's degree OR Associate/Medical Technical degree with 0-2 years manufacturing experience
• High School diploma/GED with 2-4 years manufacturing or operations experience
• Knowledge of cGMP and FDA-regulated environments
• Ability to safely handle liquid nitrogen and cryogenic materials with proper PPE
• Microsoft Office proficiency and basic mathematical skills
• Experience with inventory control and material tracking systems
• Technical writing capability and understanding of batch record documentation

Compensation: $31.90 - $38.65 per hour

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