Production Lead 2nd Shift

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.