Purpose

The R&D Warehouse Coordinator is the person responsible for maintaining and managing the entire Lake County warehouse in the support of clinical manufacture of drug products while maintaining the highest level of compliance and quality. The warehouse needs to ensure all GMP materials are in hand for the scheduled manufacture dates by coordinating with Vendors, Purchasing, Stock Rooms, Customs, Clinical Manufacturing Leads, Formulation Scientists, Analytical Scientists and Quality Assurance.

Responsibilities

• Responsible for compliance with applicable Corporate and Divisional Policies and procedures.
• Order materials and track those orders through fulfillment. Tracks inventory usage and orders resupplies as needed. Physically receives materials into the inventory management system.
• Perform sampling activities for materials that need to be tested against analytical specifications. Perform dispensing activities for extemporaneous dose preparations and assures timely delivery. Retains materials in the correct locations and keeps the warehouse in an orderly and clean manner. Reviews inventory regularly to purge aging inventory and identify and resolve any discrepancies.
• Moves materials to and from the manufacturing floor. Picks, packs and ships materials to the packaging area, third party manufacturers and commercial sites, domestic and international.
• Interfaces with Customs Operations as needed to send and receive international shipments. Manages materials within the Foreign Trade Zone (FTZ) to assure full product accountability to Customs Operations. Processes materials destruction requests. Manages the developmental inventory database and provides development materials for experimental activities upon request. Acts as the area SME for the inventory management system.
• Supports investigations of any compliance issues related to the warehouse.
• Maintains a safe working environment in the warehouse area. Maintains the quality system procedures related to warehousing activities.
• Accountable for ensuring that all activities pertaining to material handling are handled in a timely manner while maintaining the highest levels of compliance and quality. This position will be required to resolve any issues that arise pertaining to material handling in the warehouse and requires a high level of independence, with major decisions made in conjunction with the Operations Manager. Look for ways to enhance the efficiency, quality, and level of compliance of the warehouse operations.
• Decisions and actions have a direct impact on the clinical drug supply efficiency, effectiveness (cost, time and quality) and compliance. This position requires the ability to understand the customers’ needs and appropriately prioritize the overall workload. His / her actions and deliverables will impact the efficiency, quality, and compliance of all clinical drug supply shipments from the Lake County site.