Description:
The Operations Specialist position is responsible for performing production activities in compliance with applicable government regulations and guidelines as well as with company policies and procedures.
Essential Functions
- Successful completion of the training requirements associated with the execution of activities within the production function. GMP's; Safety; Policies and procedures necessary to perform the assigned tasks in the functional area for which proficiency has been achieved.
- Execute day-to day activities related to the ongoing production function. These tasks include cylinder prep, bake-out, blow-down, filling and packaging of finished drug products.
- Perform daily operations schedule; Communicate with functional Leads and Quality Assurance concerning schedule changes that may impact production requirements and QA coverage. Process staging requirements, segregation, documentation, and safety requirements; Execute the weekly schedule as required to meet production demands.
- Comply with the applicable Production Batch Records and Procedures; Review applicable Batch Records and Procedures to ensure compliance with policy, procedures and GMP's requirements. Procure components to support applicable manufacturing operations.
- Conduct an inventory of components and parts in your area of responsibility to ensure there is no interruption in the production schedule. Perform daily review of all logbooks to ensure compliance and completion as required per procedure.
- Execute equipment cleaning and preventive maintenance procedures as required within the Manufacturing area.
- Assist throughout the production department as required. Assure proper housekeeping of all facilities according to established procedures.