Manufacturing Supervisor II (3rd Shift: 11pm - 7am)

Supervise daily activities in the production area to ensure manufacturing goals and project deadlines are met while maintaining compliance with current good manufacturing practices (cGMPs), SOPs, environmental health and safety (EHS) guidelines and any other regulations that may apply. Supervise and insure efficiency and effectiveness in various areas. Ensure operational efficiency, troubleshoot and investigate as necessary. Perform all duties with a focus on optimizing safety, quality, service and cost. May supervise more than one department. Communicates guidance, support, direction and leadership through effective interactions with all personnel during daily operations. Supervises the day-to-day production, scheduling, staffing, material management, compliance, training and auditing activities. Identify/prioritize/provide resources as appropriate. Interviews, hires, coaches, motivates, develops, recognizes and manages performance of direct reports. Provides regular feedback to all direct reports. Assist in setting performance objectives and development plans and supervise progress. Reviews, approves, and leads documentation for batch and system records. Assists in release of product for distribution. Assists in meeting product release time goals. Identifies, initiates and facilitates continuous improvements, lean manufacturing activities and initiatives, such as 5S, visual management, kaizens. This role may also be responsible for identifying and implementing VIPs. Ensures resources and raw materials are applied in the most efficient and productive manner possible. Develops training content and facilitates and verifies appropriate training for employees in the area. Ensures compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required. Submits and/or maintains and distributes reports related to attendance, labor, efficiency, safety, scrap and others as needed. Performs/leads technical reviews, investigations and process improvement projects. Provides manufacturing input into integration and validation of new equipment and processes. Resolves technical, material and cGMP problems that may impact project deadlines. Provides guidance and troubleshooting assistance as needed during a deviation in the process. May represent the company during FDA inspections or provide information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs. May monitor capital expenditures and assist in developing budgets.