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.

What You’ll Do 

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

Knowledge, Skills

• Understanding of cGMPs
• Knowledge of the operation of Warehouse equipment
• Understanding of safety and operational procedures
• Ability to assist with operations, learn and ask questions
• Ability to follow technical instructions and document them
• Ability to assist and lead in troubleshooting
• Some understanding of warehouse scheduling and shift activities
• Ability to work closely and effectively in a team environment.
• Strong verbal and written communication skills
• Ability to adapt in a fast-paced changing environment

Basic Requirements

• High school diploma or GED
• 4 years of related experience in a manufacturing environment

Preferred Requirements 

• Associate degree and 2+ years of direct experience in cGMP manufacturing environment OR
• BA / BS, preferably Life Sciences or Engineering
• Equivalent Military training/experience
• Internal or after training: Qualified on unit operation

• SAP experience

WORKING CONDITIONS & PHYSICAL REQUIREMENTS 

PHYSICAL DEMANDS
Ability to ascend or descend ladders, scaffolding, ramps, etc. No X Yes
Ability to stand for prolonged periods of time. No X Yes 240 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to sit for prolonged periods of time. No X Yes 240 frequency/minutes (If yes, may specify frequency/duration: up to 15, 30, 120, 240 minutes)
Ability to conduct activities using repetitive motions that include writs, hands and/or fingers. No X Yes
Ability to operate machinery and/or power tools. No X Yes
Ability to conduct work that includes moving objects up to X pounds. No X Yes If yes, 10 lbs. X 33 lbs.
Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions. No X Yes
ENVIRONMENTAL CONDITIONS
Will work in warm/cold environments No X Yes 2-8C, -20C, -40C Range (If yes, specify approximate temperature ranges.)
Will work in outdoor elements such as precipitation and wind. X No Yes
Will work in small and/or enclosed spaces. X No Yes
Will work in heights greater than 4 feet. No X Yes