PURPOSE AND SCOPE: Provides supervisory direction to department. Reviews and analyzes production, quality control, maintenance, and operational reports to determine causes of nonconformity with product specifications, and operating or production problems. Maintains efficient and compliant production lines. PRINCIPAL DUTIES AND RESPONSIBILITIES * Supervise the daily operations of the team, including but not limited to: establishing mutual goals, assigning tasks and maintaining schedules. * Follows and enforces all clean room procedures. * Troubleshoots and corrects machinery problems as they occur; assists maintenance when necessary. * Confers with management personnel to establish production and quality control standards, develop budget and cost controls, and to obtain data regarding types, quantities, specifications, and delivery dates of products ordered. * Coordinates production activities with procurement, maintenance, and quality control activities to obtain optimum production and utilization of human resources, machines, and equipment. * Develops and implements operating methods and procedures designed to eliminate operating problems and improve product quality. * Revises production schedules and priorities as result of equipment failure or operating problems. * Consults with engineering staff relative to modification of machines and equipment in order to improve production and quality of products. * Plans production operations, establishing priorities and sequences for manufacturing products. * Inspects machines, equipment and manufacturing area to ensure specific operational performance, optimum utilization and areas meet GMP compliance. * Develops or revises Standard Operating Procedures (SOP's) and working practices. Observes workers to ensure compliance with standards. * Resolves worker grievances or submits unsettled grievances to management for action. * Compiles, stores, and retrieves production data. * Ensures all employees are properly trained and following GMP compliance. * Ensures all employees are following appropriate safety practices to provide a safe work environment. * Maintains general housekeeping of working area and plant. * Responsible for hiring, training, coaching and counseling employees, including performance reviews, disciplinary action and terminations. * Assist with various projects as assigned by a direct supervisor. * Other duties as assigned. Additional responsibilities may include focus on one or more departments or locations. See applicable addendum for department or location specific functions. PHYSICAL DEMANDS AND WORKING CONDITIONS: * The physical demands and work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. * Regularly required to use hands and fingers to handle; reach with hands and arms; talk or hear and wear personal protective equipment that may include hearing protection, hair net, bunny-suit, etc. Frequently required to stand and walk throughout a 12 hour shift. Occasionally required to sit; climb or balance and stoop, kneel, crouch. * Able to regularly lift and/or move 10 to 25 pounds, frequently lift and/or move up to 50 pounds and occasionally lift and/or move more than 100 pounds with assistance. * Regularly exposed to moving mechanical parts. * The noise level in the work environment is usually loud. SUPERVISION: May be responsible for the direct supervision of various levels of manufacturing operations staff. EDUCATION: * Bachelor's Degree required; in lieu of degree additional years of relevant experience and/or training/education may be considered. EXPERIENCE AND REQUIRED SKILLS: * 2 - 3 years' experience as an individual contributor senior role; or 1 - 3 years' experience as a Supervisor. * Understanding of FDA guidelines for finished goods drug manufacturing. * Understanding of lean principles. * A solid understanding of SPC and statistical techniques. * Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. * Ability to work with mathematical concepts. * Strong oral and written communication skills. * Proficient with PCs and Microsoft Office applications. EO/AA Employer: Minorities/Females/Veterans/Disability/Sexual Orientation/Gender Identity Fresenius Medical Care North America maintains a drug-free workplace in accordance with applicable federal and state laws.