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BARNHARDT MANUFACTURING CO INC Quality Control in Charlotte, North Carolina

Summary: Assist in the oversight of Quality Management Systems implementation and management; audit support; Quality Assurance and Quality Control operations; and compliance for the assigned business units within Fiber Business Group in accordance with established practices, processes, regulations, guidelines and standards in a safe and efficient manner.Essential Duties and Responsibilities: Other duties may be assigned.Improve, develop, and implement production/processing methods and controls to elevate quality standards in a safe and cost effective manner by having a thorough understanding of all factors and conditions that impact the processes and products, including safety and environmental impacts. Provide troubleshooting, problem analysis and technical support to the plant as requested. Use continuous improvement methods, techniques, and procedures such as daily management, problem solving, 5S, etc. to lead and facilitate continuous improvement.Ensure proper review, approval and change management to any procedure, specification, manufacturing procedure or process, equipment, instruments, test method, and validated system with potential impact on product and or process quality in assigned areas.Review and participate in the development of product specifications. Assist and support in the translation of product specifications to appropriate manufacturing instructions and documents.Plan, implement and supervise process trials in laboratories, pilot areas/equipment. Conduct test protocols and procedures, and product evaluationExecute validation activities of the various business group facilities.Participate in the internal/external audit program. Qualify suppliers/vendors, and contract organizations. Maintain audit schedules and control audit reports. Host non-regulatory and regulatory, directed and for cause audits/inspections related to GMP or quality systems and programs. Participate as necessary, in regulatory inspections at contract organizations when the inspection relates to GMP or quality systems related operations being performed. Analyze audit trends, implement corrective action and report on such trends.Analyze problems and implement solutions using critical thinking skills and focused improvement methods. Incorporate creative thinking into the problem solving approach to identify unique and different ways to make things better/more consistent/faster/cheaper/efficientValidate new processes and document the return on investment. Transfer new technologies across a range of product categories.Conduct studies and generate reports to substantiate claims regarding the safety and efficacy of new products (especially for pharmaceutical and healthcare products).Read and write technical reports and specifications, and maintain appropriate records.Initiate and generate ideas based on reading and research.Respond to customer complaints, correspondence, requests and requirements; liaise with suppliers of raw materials and resolve production problems.Provide input into planning, development and implementation of changes to policies, procedures, forms, etc.; facilitate changes in procedures, forms and practices, work flows, personnel assignments, and equipment.Develop, plan and implement special projects as assigned.Review, analyze and test manufacturing methods or materials change requests, recommend changes and write change requests to reduce costs, improve productivity, correct discrepancies and conform to new or changed customer requirements.Design and execute tests to improve quality, reduce process and product variation, identify and verify root cause with regard to problem solving.Maintain current knowledge in the field by active participation in related professional societies and regularly reviewing current technical literature.Abide by, enforce and participate in the implementation and ongoing oversight of all company safety standards and regulations.Competency: To perform the job successfully, an individual should dem

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