GMP SHIPPING LEAD

Job Summary

The GMP Shipping Lead is responsible for coordinating and executing compliant shipping and receiving activities within a biotechnology or pharmaceutical environment. This role supports cold-chain logistics, material inspection, documentation management, inventory control, ERP transactions, import/export coordination, pest-control activities, and audit readiness.
The successful candidate will work closely with internal and external stakeholders to ensure that GMP materials are packed, shipped, received, documented, and recorded accurately, on time, and in accordance with approved procedures and quality requirements.

Key Responsibilities

GMP Shipping and Receiving
Execute and/or ensure GMP shipping and receiving activities accurately, compliantly, and within required timelines.
Coordinate shipment requirements, dates, delivery schedules, and updates with senders, receivers, internal teams, and other stakeholders.
Support the timely and secure movement of GMP materials while maintaining product and material integrity and security.
Complete pack-outs, shipping checklists, and packaging requirements in accordance with SOPs and approved pack-out diagrams.
Lead or support receiving activities, including material inspection, documentation review, record retention, and ERP transactions.
Monitor the GMP shipping email group and respond to shipping and receiving requests or inquiries.
Coordinate cold-chain shipments using appropriate temperature-controlled packaging and monitoring devices.
Coordinate with import/export teams to support accurate and compliant shipping documentation and entries.
Lead weekly meetings with key stakeholders to review upcoming and in-transit shipments; resolve issues as required.
Collaborate with global logistics teams on the use of carriers, payment coding, and services issues.

Documentation and Quality Systems
Partner with Quality to ensure GMP operations. 
Complete and maintain shipping, receiving, inspection, and inventory documentation in accordance with GMP and Good Documentation Practices.
Maintain records in a complete, accurate, and readily retrievable manner.
Support audit and inspection readiness by ensuring that records, processes, and documentation are complete and compliant.
Apply quality-system principles, including deviation management, CAPAs, and change control.
Identify operational issues, support problem resolution, and contribute to process improvements.
Maintain current GMP, IATA, DGR and other required training.

ERP and Inventory Management
Perform SAP or other ERP transactions related to shipping, receiving, inventory, and material movements.
Monitor inventory levels of GMP shippers, temperature monitors, packaging materials, and other shipping supplies.
Reorder materials as needed to support ongoing shipping activity.
Coordinate with key stakeholders and peer groups to manage shared shipping and packaging supplies.
Maintain accurate stock records and report inventory levels for shippers and related materials.

Facility and Pest-Control Support
Participate in pest-control walkthroughs and preventive-maintenance activities.
Report facility concerns and work orders as required.
Support the maintenance of a clean, compliant, and inspection-ready GMP environment.

Required Qualifications and Experience

•    Two to three years of experience in biotechnology, pharmaceutical, clinical-supply, or regulated-industry logistics.
•    Experience with GMP shipping and receiving and Good Documentation Practices.
•    Knowledge of cold-chain logistics, temperature-controlled packaging, and temperature-monitoring devices.
•    Familiarity with import and export processes and related documentation requirements.
•    Experience using SAP or another ERP system for shipping, receiving, inventory, or material transactions.
•    Understanding of quality-system processes, including deviations, CAPAs, and change control.
•    Strong attention to detail and the ability to maintain accurate records.
•    Excellent written and verbal communication skills.