Associate Specialist, Value Stream Cryo Operations - Quad 1

Spectraforce Technologies; Summit (NJ); On-site; USD 27,552 - 41,328; Part time

Job summary

Spectraforce Technologies is seeking an Associate Specialist for Value Stream Cryo Operations in Summit, NJ. The role focuses on cryopreservation, storage, and material tracking for patient materials in a GMP‑regulated facility.

Responsibilities include managing cold chain transfers, maintaining chain of custody, and supporting batch records and investigations. A 6‑month term is expected with overtime as needed.

Qualifications

• Bachelor's degree or related technical degree with manufacturing/operations exposure.
• Alternate qualifications include an Associate/Medical Tech degree with 0–2 years in manufacturing/operations.
• High School diploma plus 2–4 years of manufacturing/operations experience acceptable.

Responsibilities

• Handle patient material through cryopreservation, storage, distribution and disposal.
• Maintain sample tracking and chain of custody per GMP procedures.
• Destruct obsolete samples per written procedures and maintain storage reports.
• Perform sample queries and storage reports as required.
• Assist investigations and deviations related to sample management.
• Collaborate with other departments to improve processes.
• Maintain metrics for Value Stream Cryo Operations and support cold chain transfers.
• Support cGMP batch records, deviations, and CAPA closures.
• Ensure on-time cryopreservation support per production schedule.
• Record handling data clearly according to GDPs; work with trained personnel.

Skills

Cold chain storage

cGMP/FDA knowledge

Math basics

cGMP understanding

Technical writing

MS Office

Inventory control

Biology/Medical background

Education

Bachelor's degree

Associate/Medical Technical degree

High School diploma/GED

Tools

MS Office

Job description

Position Title: Associate Specialist, Value Stream Cryo Operations

Department: Value Stream Cryo Operations

Duration: 06 Months

Location: Summit West, S-12, 07901

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's) 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.
• High School diploma/GED and 2–4 years of Manufacturing or Operations experience.

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.