The Warehouse Associate 3 position will be responsible for storage, handling, and distribution of materials and products at the Holly Springs FDBN large scale manufacturing facility, which produces Drug Substance, Drug Product, and Finished Goods products. This role will be supporting Warehouse operations in receiving, shipping, and/or logistics throughout the FDBN facility therefore this candidate will be working with multiple functions to support operations: Manufacturing, Quality, Process Sciences, and other customers as needed. The Warehouse Associate 3 will be using SAP ERP system for inventory management, cycle counting, and shipping activities while operating in a GMP facility with standard operating procedures (SOPs).

This position will require shift work or weekend hours to support operations and/or required to fulfill on-call responsibilities, as needed.

During Project Phase:

Assists in the preparation for operational readiness including but not limited to: creation/implementing new SOPs, development or transfer of warehouse business processes, testing and commissioning support with validation, and start up activities with SAP ERP.
• Interim responsibilities for operational readiness during the start-up phase of the FDBN large scale greenfield site.
• Potential travel up to 25% (international or domestic) may be required during the project phase.

In Operations:

• Supports Warehouse Operations to include unloading/loading materials in both receiving and shipping dock areas, and supporting sample shipments
• Supports production operations with materials and product movements for manufacturing areas (Drug Substance, Drug Product, Finished Goods and Weigh/Dispense as well as Raw Material Sampling)
• Subject Matter Expert (SME) level of SAP ERP system to goods issuance, receipts, picking, and shipping
• Executes and documents warehouse activities using standard operating procedures (SOPs), work instructions, and other applicable documentation in GxP operations
• Ensures inventory management by performing cycle counts, bin checks, and materials management using knowledge of SAP ERP system
• Maintains current training to perform all required activities with Warehouse operations
• Uses of a variety of powered industrial trucks (PIT), sometimes at heights of over 30 feet
• Leads department GEMBA and safety walks
• Assists/Supports with execution of qualification activities and/or validation protocols periodically for temperature controlled units, and all controlled environments in the Warehouse area: (Ambient, Cold, Freezers, Hazardous/Flammable) storage
• In collaboration with management reviews, authors and updates SOPs and Work Instructions as needed
• Trains associates on Warehouse operations
• Interfaces with Raw Material Sampling and Weigh and Dispense, supervision and outside departments
• Performs other duties, as assigned

Minimum Requirements:

• High School Diploma or GED along with 4 years experience in a cGMP manufacturing environment.

Preferred Requirements:

• Associate's Degree and 2+ years of direct experience in cGMP manufacturing environment OR Bachelor's degree, preferably Life Sciences or Engineering
• Equivalent Military training/experience