About this role
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.