What You’ll Do
Initiates and supports change management records, investigations, CAPAs and continuous improvement activities
Creates, revises, and maintains Standard Operating Procedures (SOPs), Work Instructions, Training material, and other applicable GMP documents
Supports inventory management with Warehouse team, to include cycle counting process, improvement opportunities, and investigating material
inventory discrepancies
Interfaces with associates and supervision with Manufacturing, Quality, Process Sciences, supply chain team, and internal stakeholders to support
Warehouse operations
Serves a SME in a particular warehouse area (e.g., shipping, receiving, materials management)
Supports manufacturing operations in Weigh & Dispense, Drug Substance, Drug Product, and Finished Goods areas for inventory management with
materials and product, as needed
Interfaces with SAP ERP system supporting WH operations and master data for inventory management
Ensures data integrity and compliance for audit readiness
Supports client and regulatory inspection tours and serve as process SME
Maintains, coordinates and interfaces with third party warehouse (3PL)
Identifies and/or drives improvement projects in the Warehouse
Participates in cross functional teams for improvement initiatives representing Warehouse
Other duties, as assigned.
Knowledge & Skills
Warehouse operation understanding, including sequence and cadence of activities
Experience in warehouse systems (for example, SAP)
Able to update and create documents per schedule
Understanding of cGMPs
Ability to lead in troubleshooting
Ability to mentor junior staff
Basic Requirements
High School Diploma or Equivalent with 6 years of applicable industry
experience OR
Bachelor’s degree with 2 years of applicable industry experience OR
Master’s degree with no previous experience
Equivalent military experience
Preferred Requirements
Associate's degree, preferably in life sciences, engineering or
business with 4 years of cGMP experience
Bachelor’s degree, preferably in life sciences, engineering or business
with 2 years of cGMP experience
WORKING CONDITIONS & PHYSICAL REQUIREMENTS
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Will work in environment which may necessitate respiratory protection
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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
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Ability to sit for prolonged periods of time
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Ability to conduct activities using repetitive motions that include wrists, hands and/or fingers
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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 outdoor elements such as precipitation and wind
