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The Warehouse Lead manages daily GMP warehouse operational activities, coordinates, receives, handles and moves inbound shipments of raw materials and supplies, as well as inbound and outbound shipment of starting material and product. Responsible for Quality Management systems impacted by material receipt and shipment including invoice and COA receipt, Material Specification Sheet (MSS) development, SOP revision and authoring, deviation investigation, and CAPA completion. Leads and provides work direction to warehouse associates to meet material shipping and receiving requirements.
Monitor, manage, order, reorder, handle, transport, organize, sort and maintain inventory of process gases, raw materials, consumables, gowning materials, cleaning agents and other supplies that are required to support Manufacturing and Laboratory Operations.
Support shipping process by managing all inbound deliveries of raw materials, patient material and also managing outbound shipments of manufacturing product and samples that require shipment.
Lead and provide direction to warehouse support associate and material handlers.
Collaborate with Finance, Planning, Process Development, Operations, Quality and Other Functional Groups as required.
Act as a subject matter expert for all warehouse functions (includes SOPs, daily responsibilities, inventory management systems and audit support).
Identify areas of non-compliance or gaps and implement corrective actions to address and remediate.
Execute product and other material activities in the warehouse: pack-out, goods receipt and inspection, resolve discrepancies, manage inventory, lead stock count
Maintain Operational KPIs for warehouse, receiving, storage and shipment activities. Monitor and continuously improve warehouse performance and service level
Execute warehouse SOPs and WIs and check correctness. Propose and draft new and/or changed SOPs and WIs, act as owner of SOPs and WIs
Detect and report deviation events in the warehouse, contribute to change control process. Create, edit and provide training (when applicable) for all SOPs, practices and systems related to warehouse inventory management and shipping and receiving.
Ensure we are providing materials on time and accurately to production.
Ensure accurate cycle count and organized storage of materials.
Investigate and reconcile any inventory discrepancies that are discovered.
Strictly comply with all cGMP guidelines, OSHA safety regulations and all other applicable laws and regulations.
Identify and address safety hazards within the work area and perform work in a safe manner.
Bachelor's degree in life sciences with 5 years of relevant experience in the biotech and/or pharmaceutical industry or 10 years' experience with High School Diploma
Five to seven years GMP warehouse experience
3 years of experience in the pharmaceutical or biotechnology industry in a GMP environment
Able to handle multiple long and short term tasks, while working in a high stress, fast paced start up environment.
Excellent communication skills (written & verbal).
Must be proficient in use of computer software and systems including Microsoft Office Suite.
Ability to work a flexible schedule including holidays, evenings and weekends as required.
7 to 10 years of experience in a GMP pharmaceutical or biotechnology warehouse, logistics and shipping and receiving environment.
Experience at a cGMP regulated manufacturing facility.
College degree in a Supply
Cold Chain experience
Enterprise Resource Planning (ERP) or Electronic Inventory Management System experience
Knowledge of Lean, Six Sigma and Kaizen methodologies