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Label Control Coordinator - 2nd Shift

Company: Ambu
Location: Noblesville
Posted on: August 14, 2019

Job Description:

POSITION SUMMARY: * Administer, monitor and review the label control process. RESPONSIBILITIES: * Review, evaluate, and implement label control functions for inclusion in the Quality System, as defined in the Quality System Manual and approved SOP's. * Complete accurate and efficient performance of all functions that pertain to the issuance of product labeling and the relative device history records. * Identify and remove any labeling that does not meet the specifications for print quality or correctness, including obsolete or superseded labeling. * Communicate to the Quality Assurance manager, any problem, idea, or solution that pertains to the label control system or its administration. * Interact with co-workers, supervisors, and their department personnel in a way that fosters a positive working atmosphere and encompasses a professional and helpful attitude. * Provide organization, direction, response to process problems, and documented training for personnel that directly perform duties within the label control system as defined by the Quality Assurance Manager. * Store all working master work orders ("Blue Dots") and labeling in a manner that allows efficient performance of the Label Control functions. * Maintain the label control working masters (hard copy and electronic) in a manner that precludes loss or damage, including the maintenance aspects of active and inactive product work orders and updating of any computer files that provide interdepartmental data. * Provide, upon request, reduced copies of working masters for purposes of training, revision, regulatory review, etc. * Maintain sufficient inventory and organize storage of label control supplies, including paper, case label stocks, printing stencils and thermal ribbon, ink, toner, and any other supplies required for the efficient operation of the process. * Perform data entry and retrieval of information, typing, proof-reading, filing, project management, project status report generation, and resource planning, as requested. ESSENTIAL FUNCTIONS: * Utilizing basic mathematical addition/counting principles, ensure accurate label counts. * Visually inspect labels for accuracy. * Standing for long periods of time, work at work station. * Perform verbal communication with various employees on work station team or in support of work station team. * Perform written documentation in compliance with document control procedures. * Ability to distinguish color. * Operate mechanically and/or electronically controlled equipment with moderate noise levels. * Utilizing standard computer equipment/keyboard, perform computer entry functions. * Analyze data output in the pursuit of operational improvement, development and performance enhancement. * Maneuver boxed labeling supplies at varying heights, onto shelving. PERFORMANCE CRITERIA: * Respond to problems, ideas, and solutions presented, in conjunction with Corporate needs and policies. * Provide advice and recommendations to assist the Quality Assurance personnel in making sound decisions regarding the quality of all product labeling. * Maintain a professional, helpful attitude in dealings with co-workers, supervisors, and their departmental personnel, at all times. * Maintain a clean and organized work area at all times. * Ensure compliance with all SOP's. * Maintain a strong commitment to quality at all times. * Remain flexible with regard to job assignments, at all times. * Provide accurate, legible, and complete processing documentation. * Ensure that labels are produced in accordance with all standards for quality. * Practice good hygiene * Provide equal contribution to team. * Ensure that all work is performed in compliance with CGMP's, and ISO 13485 , MDD, requirements. * Maintain respect for all equipment used in the performance of your job. * Ensure 100% accuracy of all labels. * Ensure the availability of all required labels to eliminate any delay in shipment of product. QUALIFICATIONS/EDUCATION: * High School diploma or general education degree (GED); or one to three months related experience and/or training; or equivalent combination of education and experience. * Ability to perform routine math calculations. * Ability to read and interpret documents of instruction. * Complete understanding of, MDD and ISO 13485 requirements, including Quality System regulation (formally GMP). * Knowledge of manufacturing procedures. * Ability to handle multiple priorities. * Computer software experience to include word processing and spreadsheet packages. * Knowledge of the Medical Device Manufacturing industry. * Excellent verbal and written communication skills. * Ability to work independent of direct supervision. * Ability to work well with others. * Ability to complete routine reports and correspondence. * Strong attention to detail

Keywords: Ambu, Noblesville , Label Control Coordinator - 2nd Shift, Other , Noblesville, Indiana

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