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Essential Duties and Responsibilities
- Train Production personnel on company SOPs and applicable OSHA regulations.
- Prepare daily scheduling of packaging personnel.
- Train Production Room Leaders on job specific duties.
- Supervise and oversee execution of packaging of clinical supplies as determined by the approved MIs in accordance with company SOPs and cGMP regulations.
- Review executed packaging batch records ensuring compliance with cGMP regulations, company SOPs, and MIs.
- Ensure that packaging areas are maintained in accordance with company SOPs and cGMP regulations before, during, and after any packaging operation.
- Oversee the operation of packaging equipment ensuring compliance with company SOPs and any applicable OSHA safety regulations.
- Oversee general housekeeping of packaging, labeling, assembly, and manufacturing areas.
- Monitor staffing utilization, operational flow of MIs, and equipment usage and make recommendations for improvement to management.
- Maintain, enforce and adhere to company policies to provide security and a safe environment for personnel.
- Assist in recruiting, hiring, training, timekeeping, appraising, and coaching team members and providing disciplinary action, as necessary.
- Review and write company SOPs relating to the packaging area.
- Assist in executing investigations, deviations, and customer complaints relating to the packaging area.
- Monitor non-job specific inventory and order accordingly.
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