Material Operations Specialist II

Leiden Cell Therapy Site is seeking a dynamic individual to join a team of materials management and supply chain professionals. This individual is responsible for executing routine activities related to the management, cleansing and movement of all type of materials (i.e. cold chain, ambient) supporting internal and external customers, while following Standard Operating Procedures (SOPs).

NOTE> this is a shift role.

Key Responsibilities

• Perform routine activities such as: receipt, storage, transfer, distribution, disposal and cleaning of all type of materials (ambient, cold chain, dangerous goods, etc.) as per GMP procedure.
• Prepares all type of material for shipment to internal and external parties, as per GMP procedure.
• Ensures materials are appropriately labelled in accordance with written GMP procedures.
• Perform inventory control practices including cycle counting and rejected/expired material disposition as described in the GMP procedure.
• Follow procedures to maintain a safe and organized working space.
• Performs inspection of incoming materials to the working area as per procedure.
• Uses material handling equipment - gas powered, electric and/or manual as per procedure.
• Handles materials based on Material Specifications i.e. temperature conditions, dangerous or hazardous conditions, etc. or as per procedure
• Assists in setting up operational equipment/fixtures and support facility and equipment commissioning activities as requested.
• Responds to system and equipment alarms during inside / outside office hours in rotating schedule as per GMP procedure.
• Facilitates ambient and cold chain sampling in collaboration with other department employees.
• May review GMP documentation and perform data verification.
• Coordinates internal and external customer requests across multiple unit operations during their shift to include personnel, material, and logistical needs.
• Puts away material into totes, or bags, and closes or seals them to prevent cross contamination, as per GMP procedure.
• Trains or facilitates the training of fellow associates on GMP Material Operations to ensure proficiency in all areas of operation.
• Proficiency in understanding and use of Quality Systems for Deviation, SOP revisions/creation, CAPA Management.
• Provides basic and first-line equipment troubleshooting.
• Acts as System champion and supports others in troubleshooting system issues (i.e., SAP, eWM, etc.).

• 7+ years of experience in a cGMP warehouse environment and understanding of Materials Management.
• DOT/IATA/HazMat experience and certifications a plus.
• Experience with receiving, temperature storage, issuance, and inventory control practices including cycle counting, and rejected/expired material disposition.
• Experience in cold chain logistical movement of time critical and temperature sensitive biologics.
• Knowledge of Freight forwarder and courier direct shipments and associated documentation requirements is preferred.
• Understanding controlled temperature, humidity, and pest control monitoring for cGMP environments is required.
• Understanding of physical cold chain requirements supporting the logistical movement of time critical and temperature sensitive biological material is required.
• Ability to understand and follow procedures.
• Reliable and detail oriented with organizational skills.
• Ability to communicate effectively with peers and management regarding task completion, roadblocks, and needs.
• Ability to work in a fast-paced team environment, meet deadlines and changing priorities.
• Operation of basic warehouse equipment (i.e. forklift, pallet stacker, etc.) is desirable.
• Advance experience with SAP system usage or any other Warehouse ERP system is required.
• Experience with project management is a preferred.

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Disclaimer: For any third parties or external agencies, please, be informed we do not accept unsolicited requests, proposals, applications or profiles for any of our roles at BMS.