Cryogenic GMP Warehouse Specialist - Cell Therapy Ops

AstraZeneca plc; California (MD); On-site; USD 65,000 - 90,000; Full time

Job summary

AstraZeneca plc in the Los Angeles area seeks a Warehouse Specialist responsible for receiving, inspection, release and dispensing materials for clinical cell therapy manufacturing. The role covers GDP compliance, cold chain integrity, and QA communications.

You will manage cryogenic storage, FEFO, and ensure traceability from donor to product, coordinating with QA, Clinical Operations, and couriers. Qualifications include 2-3 years in warehouse roles and a high school or associate degree;

Qualifications

• 2-3 years relevant experience in warehouse activities.
• Experience with GDP/GMP, QA documentation, and validated systems is preferred.

Responsibilities

• Chain-of-Identity/Custody control and unbroken linkage from patient/donor to product; verify IDs at each touchpoint and segregate by patient/protocol and material status.
• GDP Receiving for Patient Materials and Vectors: verify courier chain-of-custody, tamper seals, temperature traces, and documentation; record in validated WMS/ERP and quarantine with QA notification.
• Cryogenic and Cold-Chain Management: handle LN2 dewars and -80°C freezers; perform daily checks, alarms, and ALCOA+ documentation.
• FEFO, Expiry, and Retest Control: enforce FEFO for expiry-dated reagents/vectors; track retest dates; coordinate with QA to avoid delays.
• Sampling and Cleanliness: prepare materials for QC sampling with proper gowning and environmental controls; maintain chain-of-custody.
• GMP Kitting for Manufacturing Runs: build patient-specific kits with component reconciliation and line clearance; preserve kit genealogy.
• Material Movements and Line-Side Delivery: put-away, picking, and delivery to suites with right-first-time accuracy; verify lot and storage conditions.
• Qualified Packaging and Lane Validation: condition and shipper validation per SOP; document pack-out and sign-offs.
• Patient-Specific Shipment Coordination: schedule time-definite pickups; maintain real-time communication with Clinical Ops and Manufacturing.
• Audit and Inspection Readiness: support audits with chain-of-identity controls and cold-chain validation evidence.

Education

High School Degree Or Associate Degree

Job description

AstraZeneca plc in the Los Angeles area seeks a Warehouse Specialist responsible for receiving, inspection, release and dispensing materials for clinical cell therapy manufacturing. The role covers GDP compliance, cold chain integrity, and QA communications.

You will manage cryogenic storage, FEFO, and ensure traceability from donor to product, coordinating with QA, Clinical Operations, and couriers. Qualifications include 2-3 years in warehouse roles and a high school or associate degree;