Warehouse Specialist

The Warehouse Specialist will be responsible for warehouse operations including receipt, incoming inspection, release and dispensing of materials required for clinical cell therapy drug product manufacturing and development activities at multiple facilities in the Los Angeles Area (Santa Monica, CA and Tarzana,CA).

Role Context

Cell therapy operations are patient-specific and time-critical. Materials include apheresis starting material, viral vectors, critical reagents, single-use assemblies, and finished cellular products stored at cryogenic or controlled temperatures. The role safeguards chain-of-identity/custody, cold chain integrity, and right-first-time documentation across receiving, storage, kitting, and shipment.

Responsibilities and Expectations

· Chain-of-Identity/Custody Control: Maintain unbroken linkage from patient/donor to product using unique identifiers. Double-verify IDs at each touchpoint (receiving, storage, kitting, shipment). Physically and systemically segregate by patient/protocol and material status (Quarantine/Released/Rejected).

· GDP Receiving for Patient Materials and Vectors: At receipt, verify courier chain-of-custody forms, tamper seals, temperature traces, and documentation (e.g., protocol ID, subject ID, CoA/CoC for reagents/vectors). Record contemporaneously in validated WMS/ERP and place into quarantine with immediate QA notification.

· Cryogenic and Cold-Chain Management: Handle LN2 vapor-phase dewars and ultra-low freezers (−80°C) for patient materials and finished products; 2–8°C and CRT for reagents and disposables. Perform daily checks, alarm response, excursion documentation, and trending using mapped, calibrated sensors under ALCOA+ principles.

· FEFO, Expiry, and Retest Control: Enforce FEFO for expiry-dated reagents and vectors. Track retest dates and minimum remaining shelf life rules; coordinate proactively with QA when approaching expiry or retest to avoid schedule impact.

· Sampling and Cleanliness: Prepare materials for QC sampling per SOP with proper gowning and environmental controls. Maintain clean, controlled sampling areas; complete chain-of-custody and reconciliation of samples back to parent lots.

· GMP Kitting for Manufacturing Runs: Build patient-specific kits (bags, tubing sets, filters, connectors) with full component reconciliation, label verification, and line clearance to prevent mix-ups. Preserve kit genealogy records tied to patient/protocol and batch records.

· Material Movements and Line-Side Delivery: Execute put-away, picking, and delivery to manufacturing suites with right-first-time accuracy. Verify lot, quantity, status, storage condition, and patient/protocol identifiers on every transaction; prevent unauthorized movement from quarantine.

· Qualified Packaging and Lane Validation (GDP): Condition validated cryogenic shippers (dry shippers) and CRT/2–8°C shippers per SOP; place calibrated data loggers; follow lane risk assessments and courier instructions specific to “vein-to-vein” timelines. Document pack-out and sign-offs.

· Patient-Specific Shipment Coordination: Schedule time-definite pickups with specialty couriers; prepare contingency plans (backup shippers, LN2 availability, alternate routes). Maintain real-time communication with Clinical Operations and Manufacturing; quarantine returns until QA disposition.

· Deviation/CAPA and Change Control: Immediately contain and document issues (temperature excursions, label mismatches, shipment delays, damages). Initiate deviations, participate in root-cause analysis, and execute CAPA tasks. Observe approved change controls for process or equipment updates.

· Data Integrity and Electronic Systems: Use validated WMS/ERP/eQMS with role-based access and audit trails; complete records contemporaneously, legibly, and indelibly (ALCOA+). Avoid backdating and unofficial logs; ensure traceability for chain-of-identity/custody.

· Environmental and Equipment Qualification Support: Perform routine checks of qualified storage (IQ/OQ/PQ complete, thermal mapping current). Escalate out-of-tolerance equipment, assist with calibration/maintenance scheduling, and record product impact assessments as directed.

· EHS and Biosafety: Apply LN2 safety (oxygen monitoring, ventilation, PPE) and biosafety for human-derived materials. Follow spill response, sharps handling, and waste segregation procedures; report incidents and near-misses promptly.

· Audit and Inspection Readiness: Keep areas organized and records readily retrievable. Support internal/external audits (FDA, EMA, MHRA) by presenting chain-of-identity controls, cold-chain validation evidence, and compliant documentation within your training scope.

· Cross-Functional Coordination: Communicate with QA/QC for sampling and release, Manufacturing for schedule alignment, Clinical Operations for patient slots, and couriers for pickup/delivery. Use tier meetings and clear escalation paths to protect timelines.

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