Associate Specialist, Value Stream Cryo Operations - Quad 4

Spectraforce Technologies; Summit (NJ); On-site; USD 30,307 - 46,838; Full time

Job summary

Spectraforce Technologies in Summit, NJ, seeks an Associate Specialist to support Value Stream Cryo Operations at the CAR-T manufacturing facility. You will cryopreserve patient materials, manage LN2 storage, and ensure timely sample handling, custody, and documentation in a GMP environment.

The role requires 0–2 years of related experience or equivalent education, willingness to work Wed-Sat shifts with overtime, and collaboration across teams to maintain cold chain integrity and accurate batch

Qualifications

• Bachelor's or Associate/Medical Tech degree with 0–2 years of manufacturing or operations experience.
• Or High School diploma/GED with 2–4 years of manufacturing or operations experience.
• Experience with cold chain sample storage and transfer.
• Knowledge of cGMP/FDA regulated industry.
• Basic mathematical skills.
• Technical writing capability.
• Proficient in MS Office applications.
• Inventory control and/or management.

Responsibilities

• Handle patient material throughout cryopreservation, storage, distribution, transfer, and disposal.
• Maintain sample tracking and chain of custody records per GMP procedures.
• Ensure obsolete or expired samples are destroyed per procedures.
• Perform sample queries and periodic storage reports as required.
• Assist management with investigations and deviations related to sample management.
• Collaborate across departments to improve process efficiencies.
• Maintain metrics for the Value Stream Cryo Operations group.
• Facilitate cold chain transfers of material as required.
• Perform tasks for Cell Therapy products to support value stream outputs per cGMP SOPs/WIs.
• Align timing with production schedule for on-time Cryopreservation support.
• Cryopreserve patient material daily; manage LN2 storage inventory.
• Support batch record executions, deviation investigations, CAPA closures.
• Ensure documentation is correct and address errors expeditiously.
• Work with management to ensure adequately trained personnel available.
• Record patient material handling data in clear, proper GDP format.
• Problem-solve with minimal supervision in a team-based environment.
• Overtime may be required; work staggered day shift hours.

Skills

Cold chain storage

CGMP/FDA knowledge

Mathematical basics

Technical writing

MS Office

Inventory control

Biology/Chemistry background

Education

Bachelor's or Associate/Medical Tech degree

HS diploma with 2–4 years experience

Job description

Position Title

Associate Specialist, Value Stream Cryo Operations

Department

Value Stream Cryo Operations

Duration

06 Months

Location

Summit West, S-12, 07901

Schedule: Wed-Sat, alternate Wednesday, 5:00 PM – 5:30 AM

PURPOSE AND SCOPE OF POSITION

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. This includes but is not limited to cryopreservation, storage, inventory control, chain of custody, and material tracking.

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.
• Performs tasks for Cell Therapy products to support product Value Stream outputs according to Current Good Manufacturing Practices (cGMP) following the current, approved Standard Operating Procedures (SOPs) and Work Instructions (WIs).
• Maintains timing according to the production schedule to ensure on‑time Cryopreservation support.
• Cryopreserve patient material daily, store and manage inventory of material in LN2 storage locations.
• Supports manual and electronic batch record executions, deviation investigations, and closure of CAPAs.
• Maintains timing according to the production schedule to ensure on‑time logistics.
• Ensures all documentation is correct and addresses procedural/documentation errors expeditiously and effectively.
• Work with management to ensure adequately trained personnel are available to perform all Value Stream Cryo Operations activities.
• Records patient material handling data and information in a clear, concise format according to proper GDPs.
• Able to problem‑solve with minimal supervision.
• Works in a team‑based, cross‑functional environment to complete tasks required by shift schedule.
• Other duties may be assigned, as necessary.
• Available to work overtime when business requires.
• Willing to work staggered day shift hours.

Education and Experience

• Bachelor's degree OR Associate/Medical Technical degree and 0–2 years of Manufacturing or Operations experience.
• OR High School diploma/GED and 2–4 years of Manufacturing or Operations experience.

Required Experience and Skills

• 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 is a plus.