GMP SHIPPING LEAD
About The Position
The GMP Shipping Lead coordinates and executes compliant shipping and receiving activities in a biotechnology or pharmaceutical environment. The 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 works with internal and external stakeholders to ensure GMP materials are packed, shipped, received, documented, and recorded accurately, on time, and in accordance with approved procedures and quality requirements. The role also partners with Quality, maintains GMP and shipping records, supports quality-system processes and inspections, manages shipping supplies and inventory, and helps maintain a clean, compliant, inspection-ready environment.
Requirements
- 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 ability to maintain accurate records.
- Excellent written and verbal communication skills.
Responsibilities
- Execute or ensure GMP shipping and receiving activities are accurate, compliant, and completed 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 their integrity and security.
- Complete pack-outs, shipping checklists, and packaging requirements according to 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 on shipping documentation and entries.
- Lead weekly meetings with key stakeholders to review upcoming and in-transit shipments and resolve issues as required.
- Collaborate with global logistics teams on carriers, payment coding, and service issues.
- Partner with Quality to support GMP operations.
- Complete and maintain shipping, receiving, inspection, and inventory documentation in accordance with GMP and Good Documentation Practices.
- Maintain complete, accurate, and readily retrievable records.
- Support audit and inspection readiness by ensuring 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.
- 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.
- Coordinate with stakeholders and peer groups to manage shared shipping and packaging supplies.
- Maintain accurate stock records and report inventory levels for shippers and related materials.
- Participate in pest-control walkthroughs and preventive-maintenance activities.
- Report facility concerns and work orders as required.
- Support a clean, compliant, and inspection-ready GMP environment.
Benefits
- Medical
- Dental
- Vision
- Life insurance and AD
- Disability insurance
- Retirement plan
- Paid time off
- Holiday time off (varies by site/state)
- Associate Shopping Program
- Health and Wellness Programs
- Discount Marketplace
- Identity Theft Protection
- Pet Insurance
- Commuter Benefits
- Employee Assistance Program
- Flexible Spending Accounts (FSAs)
- Paid Parental Leave
- Personal Leave
- May be eligible for additional paid and/or unpaid time off benefits in accordance with applicable laws
- Employee Referral Bonus
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What This Job Offers
Job Type
Full-time
Career Level
Mid Level
Education Level
No Education Listed
