Ensures the proper systems and resources are in place to meet production schedules on time and that product is manufactured to specification and in accordance with SOP’s, cGMP’s, and safety procedures. Provides and supervises instructions to the manufacturing department to ensure that all activities are followed as guidelines on GMP, Safety, SOPs and policies at Niagara. Reviews and updates SOPs, deviations, and CAPAs and performs different roles as directed by upper manufacturing management. Supervises manufacturing group leaders and hourly staff in proper operating aseptic techniques and produces. Oversees Indirectly/directly all hourly employees in the performance of their duties. Develops information and compiles reports concerning scheduling, production goals, equipment and maintenance problems and other studies or reports as requested. Coordinates manpower needs in support training department to achieve personnel training. Monitors production schedules. Monitors data during all manufacturing activities. Drives employee and equipment productivity to achieve optimum results. Implements strategy from upper manufacturing management. Provides clear updates, goals, and direction to the team in support of the daily production plan. Confers with other department management to coordinate the scheduling of operations to achieve required deadlines. Develops department employees through orientation, training, establishment of objectives, communication of rules and policies while building employee morale and motivation. Maintains compliance with company policies, cGMP’s, safety standards, and good housekeeping practices. Monitors and controls production schedules and activities to ensure the meeting of departmental performance objectives and budgets. Supervises, coordinates and controls the production and operating activities to ensure optimum utilization of personnel, materials, and equipment. Conducts continuous review and follow-up on projects to ensure completion of assigned work. Review documents such as Protocols, Batch Records, Change Controls, Deviations, CAPAs, Risk Assessments, etc. Evaluates the performance and production of staff; maintains records on performance. Advises department management on matters relating to daily operations and makes recommendations for improvements when feasible. Recommends and implements value and process improvement programs. Ensures adequate resources are available to manufacture product (equipment, supplies, and labor). Supports investigations, and document corrections/modification are done effectively and in a timely manner. Ensure direct reports are trained and work in compliance with applicable SOPs, GM - Ps, regulatory requirements, safety, environmental and company policies - Listen to Group Lead feedback and address team members feedback. Monitor team members’ performance to ensure all training is current and to determine if any additional training is needed and work with the department supervisor to address. Provide leadership and direction to Group Leads and employees on a daily basis. Ensure that all Batch Production Records are correctly filled out and completed in a timely fashion, before it is handled to Quality Assurance for review. Demonstrate the ability to set-up and operate any equipment used in immediate work area. Troubleshoot equipment and have the ability to problem solve any issues that arise. All other duties as assigned. Qualifications. Minimum Qualifications:4 Years – Experience in Field or similar manufacturing environment 4 Years – Experience in Position 4 Years – Experience managing people/projects - experience may include a combination of work experience and education. Preferred Qualifications:6 Years– Experience in Field or similar manufacturing environment 6 Years – Experience working in Position 6 Years – Experience managing people/projects - experience may include a combination of work experience and education. Competencies. List out all of the competencies required for the position following these guidelines:List what tools, equipment, or work aids are used and level of proficiency (Beginner, Intermediate, Advanced) expected for the role. Performs work under direct supervision. Handles basic issues and problems, and refers more complex issues to higher-level staff. Possesses beginning to working knowledge of subject matter. Strong verbal, writing, and presentation skills to communicate effectively with immediate team and peers. Analytical and problem solving skills. Ability to work well in collaborative group environments. Strong attention to detail and organization. Intermediate knowledge of and experience with Microsoft Word, Excel, Access, and Outlook.