Warehouse Specialist

AstraZeneca•Los Angeles, CA

10d

About The Position

The Warehouse Specialist manages warehouse operations supporting clinical cell therapy drug product manufacturing and development across multiple facilities in the Los Angeles area, including Santa Monica and Tarzana. The role handles patient-specific and time-critical materials, including apheresis starting material, viral vectors, reagents, single-use assemblies, and finished cellular products stored at cryogenic or controlled temperatures. It safeguards chain of identity and custody, cold-chain integrity, and accurate documentation throughout receiving, storage, kitting, and shipment. The position performs GDP- and GMP-aligned material handling and documentation, supports patient-specific manufacturing schedules and shipments, and coordinates with Quality Assurance, Quality Control, Manufacturing, Clinical Operations, and specialty couriers. It also supports equipment and environmental qualification, audit readiness, safety, training, and continuous improvement under controlled GxP processes.

Requirements

High school degree or associate degree.
Two to three years of relevant experience in warehouse activities.

Responsibilities

Maintain chain-of-identity and chain-of-custody controls using unique identifiers, double-verification, and physical and electronic segregation by patient, protocol, and material status.
Receive patient materials and vectors by verifying chain-of-custody forms, tamper seals, temperature records, and required documentation; record receipts in validated systems, quarantine materials, and notify QA.
Manage cryogenic, ultra-low-temperature, refrigerated, and controlled-room-temperature storage, including daily checks, alarm response, excursion documentation, and temperature trending.
Enforce FEFO for expiry-dated materials; track retest dates and shelf-life requirements and coordinate with QA on approaching expiry or retest dates.
Prepare materials for QC sampling using required SOPs, gowning, and environmental controls; maintain sampling-area cleanliness and reconcile samples to parent lots.
Assemble patient-specific GMP kits, reconcile components, verify labels, perform line clearance, and maintain kit genealogy records linked to patient, protocol, and batch records.
Perform put-away, picking, and delivery to manufacturing suites while verifying lot, quantity, status, storage conditions, and patient or protocol identifiers; prevent unauthorized movement from quarantine.
Prepare qualified cryogenic and controlled-temperature shippers, place calibrated data loggers, follow lane risk assessments and courier instructions, and document pack-outs and approvals.
Coordinate patient-specific shipments and time-definite courier pickups; prepare contingencies, communicate with Clinical Operations and Manufacturing, and quarantine returns pending QA disposition.
Contain and document deviations such as temperature excursions, label mismatches, shipment delays, and damage; initiate deviations, participate in root-cause analysis, complete CAPA tasks, and follow approved change controls.
Use validated WMS, ERP, and eQMS systems with role-based access and audit trails; complete contemporaneous, legible, indelible records in accordance with ALCOA+ principles and maintain traceability.
Perform routine checks of qualified storage equipment; escalate out-of-tolerance conditions, assist with calibration and maintenance scheduling, and record product impact assessments as directed.
Follow LN2 safety and biosafety requirements, including oxygen monitoring, ventilation, PPE, spill response, sharps handling, and waste segregation; report incidents and near-misses.
Maintain organized work areas and retrievable records, and support internal and external audits and inspections within the scope of training.
Coordinate with QA/QC, Manufacturing, Clinical Operations, and couriers to support sampling, release, schedules, patient slots, and pickup or delivery.
Contribute to quality-focused performance measures, including inventory and pick/issue accuracy, dock-to-quarantine time, release turnaround, temperature excursions, shipper performance, and on-time delivery.
Maintain current training and qualifications in SOPs, GDP/GMP, data integrity, biosafety, cryogenic handling, systems, and equipment; perform only tasks for which qualified.
Propose Lean and 5S improvements while preserving validated states and verify changes through controlled documentation before adoption.