What You’ll Do
In Project:
- Potentially travels up to 25% of work time, including domestic and/or international
- Assists in the preparation of operational readiness (e.g., creation/implementing new SOPs, development, or transfer of warehouse business
processes, testing and commissioning support with validation, and start up activities with SAP ERP)
In Operations:
- Completes 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 (e.g., Drug Substance, Drug Product, Finished
Goods and Weigh & Dispense, and Raw Material Sampling)
- Leads SAP ERP system as subject matter expert (SME) to goods issuance, receipts, picking, and shipping
- Executes and documents warehouse activities using SOPs, work instructions, and other applicable documentation in GxP operations
- Leads inventory management by performing cycle counts, bin checks, and materials management
- 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
- Assist and supports with execution of qualification activities and/or validation protocols periodically for temperature-controlled units, and all
controlled environments in the Warehouse area (e.g., ambient, cold, freezers, hazardous/flammable storage)
- Reviews, authors and updates SOPs and work instructions and trains associates on Warehouse operations
- Interfaces with Raw Material Sampling and Weigh & Dispense, supervisors, and outside departments
- Support the scheduling of daily activities on the warehouse floor and acts as a back-up for the manager
- Leads troubleshooting as required for operational issues
- Assists management with shift huddles and tier escalations
- Assists management with investigations support and continuous improvement projects
- Leads cycle counts and materials management
- Works shift work (weekend and potential for nights and on-call coverage)
- Performs other duties, as assigned
Knowledge, Skills or Abilities
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
- Strong troubleshooting ability
- Perform warehouse scheduling and plan shift activities
- Strong verbal and written communication skills
- Strong time management skills
- Ability to adapt in a fast-paced environment, pivot and adjust plans accordingly
- Ability to think critically and have superior problem-solving skills
- Ability to build relationships to work with team, cross-functionally, and globally
- Effective communication, both written and oral
Basic Requirements
High School Diploma or GED with 8 years related experience in
manufacturing environment
- Associate’s Degree with 6 years related experience in manufacturing
environment
- Equivalent Military experience
Preferred Requirements
Bachelor’s degree in life Sciences, Engineering, or Business with 4
years of related experience in manufacturing environment
- Fully qualified in a functional area also acting as an SME on all unit
operations within that function
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
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Will work in environment operating a motor vehicle or Powered Industrial Truck
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Ability to ascend or descend ladders, scaffolding, ramps, etc.
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Ability to stand for prolonged periods of time - Up to 240 Minutes
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Ability to sit for prolonged periods of time - Up to 240 Minutes
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Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers.
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Ability to operate machinery and/or power tools.
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Ability to conduct work that includes moving objects up to 33 pounds
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Ability to bend, push or pull, reach to retrieve materials from 18” to 60” in height, and use twisting motions.
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Will work in warm/cold environments
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Will work in heights greater than 4 feet.
