Patient Materials Operations Associate — GMP Lab Support

Spectraforce Technologies; Summit (NJ); On-site; USD 55,000 - 70,000; Full time

Job summary

Spectraforce Technologies is seeking an Associate, Patient Materials Operation in Summit, NJ. This role supports QC sample and material management for CAR T manufacturing, including inventory, chain of custody, and distribution, within a GMP-regulated facility.

Responsibilities include handling samples, maintaining records, managing inventory, and collaborating with multiple departments to ensure compliant processes and timely delivery.

Qualifications

• Experience with cold chain storage and transfer.
• Experience working in a GMP regulated environment.
• Ability to work in a classified cleanroom environment and follow gowning requirements.
• Ability to follow and apply global regulatory and GMP requirements.
• Ability to follow SOPs.
• Ability to work in a collaborative team environment.

Responsibilities

• Handle test samples throughout their lifecycle including receipt, storage, distribution, transfer and disposal.
• Maintain sample tracking and chain of custody records per GMPs and procedures.
• Destroy obsolete or expired samples and materials per procedures.
• Perform sample queries and periodic storage reports as required.
• Assist management with investigations and deviations related to sample management.
• Collaborate with other departments to identify and implement process efficiencies.
• Maintain laboratory inventory including reagents, media, consumables; manage reference standards.
• Ensure materials are labeled and traceable per GMPs and procedures.
• Support QC materials including maintaining metrics and facilitating cold chain transfers.
• Collaborate with supply chain, warehouse and lab services to stock QC supplies.

Skills

Cold chain storage

GMP environment

Gowning procedures

SOP adherence

Team collaboration

Multitasking & prioritization

Education

2+ years of relevant work experience in regulated environment or equivalent

Job description

Spectraforce Technologies is seeking an Associate, Patient Materials Operation in Summit, NJ. This role supports QC sample and material management for CAR T manufacturing, including inventory, chain of custody, and distribution, within a GMP-regulated facility.

Responsibilities include handling samples, maintaining records, managing inventory, and collaborating with multiple departments to ensure compliant processes and timely delivery.