SUMMARY Directs and coordinates activities of production department(s) in processing materials or manufacturing products by performing the following duties personally or through subordinate supervisors. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following, additional duties may be assigned: Manages supervisors to control the activities of production personnel, machine mechanics, and material handlers to meet customer requirements for quality, quantity, and ship date. Establishes production schedules and ensures that required documentation is approved and available to production and quality assurance personnel. Ensures that assigned area is adequately staffed; manages inventories, resources, and supplies to control productivity, quality, timely delivery, and production costs. Ensure that all products packaged conform to customer and Company specifications and standards. Plans department operations by reviewing production orders and/or schedules to ascertain product types, quantities, and specifications. Establish manufacturing priorities and sequences for the product packaging operation within incumbent’s area of responsibility to meet scheduled delivery dates, and the weekly production schedules established by the Production Planning Department. Tours the production area with the responsible supervisors each week to review the production and quality data. Discuss production issues with production personnel. Reinforces the desired behaviors and activities of subordinates for improving productivity, quality, on-time delivery, safety, and production costs. Investigates and resolves operational, manufacturing, maintenance, and quality discrepancies, and composes investigation reports to correct operational problems and prevent any reoccurrences with minimum costs and operational delays. Reviews and provides constructive criticism of investigational reports for other management personnel and subordinates. Leads production supervisors, operators, mechanics, material handlers, and quality assurance personnel to resolve production problems. Works with other production managers and other departments to improve production methods, equipment performance, and product quality. Provides pinpointed objectives for each subordinate to achieve. Applies performance metrics to track subordinates’ progress toward meeting or exceeding the objectives. Delivers positive reinforcement for achieving desired results and appropriate corrective consequences for failing to meet performance standards. Inspects and evaluates production equipment and machinery to ensure production readiness and optimum utilization. Retrieves, compiles and evaluates production data to identify opportunities for improvement and evaluate equipment and labor efficiency and utilization. Reviews and approves validation documentation. Ensures fair and consistent administration of applicable Company policies and procedures on attendance, productivity, product quality, timeliness, cost, equipment maintenance, and housekeeping. Applies documented criteria for promotions, transfers and salary recommendations. Resolves employee grievances or works closely with Human Resources and the Plant Manager to resolve unsettled grievances. Actively participates and ensures adherence to Company policies and programs on occupational health and safety, and good manufacturing practices (GMP) procedures. Recommends, composes, and expedites approval of procedures and revisions to procedures to facilitate quality, productivity and compliance. Provide feedback to co-workers, engineers, quality assurance, and other Company management on a regular basis to ensure efficient and effective operations. SUPERVISORY RESPONSIBILITIES Managed 5 – 15 subordinate supervisors who supervise a total of 10 - 100 employees in the Production Department. Responsible for overall direction, coordination, and evaluation of this unit. Also directly supervises 1 - 5 non-supervisory employees. Carries out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems. QUALIFICATIONS To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. EDUCATION and/or EXPERIENCE Bachelor's degree from four-year college or university in a technical discipline; or a minimum of five years related experience in an FDA Medical/Pharmaceutical regulated industry and/or training; or equivalent combination of education and experience. LANGUAGE SKILLS Demonstrated ability to comprehend overall business operations including financial profit and loss reports, income statements, balance sheets, marketing and sales probability and forecasts, variance reports including labor and equipment efficiency and utilization. Demonstrated ability to read, write, and speak English. Demonstrated ability to read, analyze, and interpret general business periodicals, professional journal, technical procedures, and government regulations. Demonstrated ability to investigate production and quality issues, write reports, business correspondence, production procedures, and policy manuals. Demonstrated ability to make presentations to groups of managers, customers and general public, and respond to questions. Demonstrated ability to engage employees to work as a team to achieve results that exceed management expectations. MATHEMATICAL SKILLS Demonstrated ability to perform basic mathematical, algebra, and geometry functions including discounts, interest, commissions, percentages, ratios, areas, circumferences, volume, statistics, and probability. REASONING ABILITY Demonstrated ability to comprehend overall business operations including financial profit and loss reports, income statements, balance sheets, marketing and sales probability and forecasts, variance reports including labor and equipment efficiency and utilization. Demonstrated ability to solve practical problems and deal with concrete variables in situations where limited numbers of variables exist. Ability to interpret a variety of instructions provided in written, oral, diagrams, or schedule form. CERTIFICATES, LICENSES, REGISTRATIONS Demonstrated ability to operate computer hardware and software including the Company’s ERP system, MS Office suite to retrieve, compile, evaluate and present production performance data. Experience and competence with ERP systems including financial reports and Time and Attendance software. PHYSICAL DEMANDS The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. While performing the duties of this job, the employee is regularly required to stand, walk, and talk or hear. The employee is occasionally required to sit; use hands to finger, handle, or feel; reach with hands and arms; climb or balance; and stoop, kneel, crouch, or crawl. The employee must regularly lift and/or move up to 10 pounds and occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.