Material Operations Specialist II: Cold Chain & GMP

Bristol Myers Squibb EU Policy; Leiden; On-site; EUR 65,000 - 90,000; Full time

Job summary

Bristol Myers Squibb Netherlands is seeking a dynamic Material Operations Specialist II to join Leiden Cell Therapy Site, supporting the management, cleansing and movement of materials including ambient and cold chain, in a GMP environment.

This shift role requires executing routine activities, inventory control, labeling, and coordination with internal and external customers, under SOPs.

Qualifications

• 7+ years in a cGMP warehouse environment.
• 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.
• Advanced experience with SAP system usage or any other Warehouse ERP system is required.
• Experience with project management is a preferred.

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.).

Skills

Material handling

GMP compliance

Attention to detail

Communication skills

Teamwork

DOT/IATA/HazMat

Cold chain knowledge

Problem solving

Shift work

Tools

SAP

Job description

Bristol Myers Squibb Netherlands is seeking a dynamic Material Operations Specialist II to join Leiden Cell Therapy Site, supporting the management, cleansing and movement of materials including ambient and cold chain, in a GMP environment.

This shift role requires executing routine activities, inventory control, labeling, and coordination with internal and external customers, under SOPs.