• Adhere to GMP requirements, biosafety related regulations, Quality Systems, and other regulations to ensure the timeliness, correctness, authenticity, integrity, and traceability of information and data during the receipt, storage, and distribution of materials and products, and ensure the consistency of accounts, materials, and inventory management.
• Evaluate, pick, and replenish cleaning gowning materials daily.
• Schedule and prioritize daily activities as needed.
• Responsible for supervising warehouse personnel to strictly implement SMP/SOP’s that meet GMP regulations.
• Develop a training plan for the warehousing and logistics department and ensure that warehouse personnel receive corresponding training.

• Revise SOPs, FORMs, as needed. Coordinates with QA on warehouse-related deviations,

• Responsible for establishing processes and ledger management for cold chain inventory including the receipt, storage, and distribution of blood products and CAR-T materials.
• Complete other tasks assigned by line manager.

• Bachelor’s degree with 6+years of experience; or
• Associate degree with 7+years warehouse experience, preferably in a pharmaceutical environment
• Ability to effective use Microsoft program such as Word,Excel and Outlook.
• Strong communication skills(e.g.,clear and concise),both written and verbal and a team player.
• Experience with ERP,Veeva,MES a plus.
• Experience in cGMP warehouse environment or Quality support of Warehouse Operations
• Good decision making with strong judgment through collaboration and consideration of others point-of-view.
• Understanding of cGMP for cell therapy warehouse.
• Flexibility to work on any shift required to accommodate the business needs.

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