Senior Materials Technician - GMP

Job Title: Senior Materials Handler Technician, VCGT Materials Management

Department: Manufacturing / Supply Chain

Location: Boston, MA

Classification: GMP Manufacturing/Science

Job Summary:

In this position, you will be responsible the daily receiving, storage, and material issuance activities for VCGT cGMP warehouses. The position will be required to perform and document daily warehouse operations in a cGMP environment, while maintaining high level of attention to detail, good documentation practices, ability to follow procedures as written, and train junior associates. The Sr Material handler gowns into classified clean room environments to perform inventory and replenishment activities. This position requires daily interactions with manufacturing staff, Planning, Procurement, Quality Control, Quality Assurance, and other Materials Management staff to ensure material needs are met.

Key Responsibilities include:

• Receive and store materials per cGMP guidance and applicable procedures.
• Ensure timely receipt, storage, stocking, picking, issuing, and shipping of materials.
• Perform cycle counts and participate in inventory reconciliation efforts
• Pick materials per manual requests or ERP generated move orders and stage kits for Manufacturing activities.
• Provide support for handling of raw materials, cleaning reagents, gowning supplies and consumables, including sanitization of all items being transferred into the cleanrooms.
• Ensure that all required materials and PPE are available for GMP cleaners before end of shift.
• Ensure all warehouse and cleanroom storage areas are inspection and audit ready.
• Demonstrate proficiency in the use of the ERP system (Oracle) and execute real time transactions.
• Ensure accurate inventory is maintained and inventory discrepancies are communicated.
• Ensure compliance and execution against all SOPs related to GMP warehouse operations.
• Utilize Oracle to complete requests for materials and subsequent deliveries.
• Ensure materials are shipped in correct temperature conditions and are handled appropriately.
• Safely operate all motorized equipment including forklift trucks, electric pallet jacks, lifts, and company vehicles.
• Remain current on DOT and Hazmat regulation.
• Perform label, packaging, and serialization steps per current procedures.
• Operates in 2 to 8C and -20C cold rooms with appropriate PPE.
• Coordination of LN2 dewars and operation of controlled rate freezers (CRF) in support of drug product storage.
• Performing cold chain pack-outs for drug product shipments

Required Qualifications

• Minimum of 3 years’ experience working within a cGMP supply chain environment and/or with GMP regulations.
• High School Degree
• Works independently, exercises sound judgment when troubleshooting.
• Experience in Logistics, Distribution, Warehousing, and Supply Chain.
• Strong knowledge of good documentation practices.
• Strong understanding of storage and shipping of cold chain products in the Biotech/Lifesciences industry and the associated documentation requirements.
• Knowledge of common ERP systems.
• Ability to perform the physical demands of the role, including lifting moderately heavy boxes and standing for long periods of time.
• Valid and active Driver’s License with the ability to obtain a DOT medical card