The coordinator is responsible for maintaining and managing the CDSM Lake County warehouse in support of clinical manufacturing of drug products while maintaining highest level of compliance and quality. The coordinator 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 scientist, analytical scientists, and QA.
Responsibilities:
- Responsible for compliance with applicable corporate and divisional policies and procedures
- Orders materials and track orders through fulfillment
- Tracks inventory usage and replenish as needed.
- Physically receives material into the inventory management system.
- Performs sampling activities for materials that need to be tested against analytical specifications.
- Retains material in 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 from and to the manufacturing floor.
- Pick, pack, and ships material to the packaging area, third party manufacturers, and commercial sites both domestically and internationally
- Manages material within the FTZ to assure full product accountability to GTC.
- Processes materials and destruction requests
- Acts as SME for inventory management system.
- Leads the warehouse pack-out area including the day-to-day coordination of the shipping activities.
- Executes day-to-day warehouse activities in compliance with departmental SOPs and CGMPs
- Supports investigations of any compliance issues related to the warehouse.
- Maintains a safe working environment in the warehouse.
- Accountable for ensuring all activities pertaining to material handled in a timely manner while maintaining highest level of compliance and quality.
- Responsible for resolving issues pertaining to material handling in the warehouse.
- Responsible for understanding the customer’s needs and prioritizing the workload appropriately.
- Coordinator’s actions will impact the efficiency, quality, and compliance of all clinical drug shipments from Lake County warehouse