Job Description

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. GMPs; 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.
• Comply with the applicable Production Batch Records and Procedures; Review applicable Batch Records and Procedures to ensure compliance with policy, procedures, and GMP 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.

Minimum Requirements

• High school diploma required, PTEC degree preferred.
• Technical background in Chemistry or Compressed Gases with experience working in a manufacturing environment.
• Knowledge of CGMPs
• Experience using an ERP system such as SAP is preferred.

Job Tags

Similar Jobs