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Job Details

Quality Manager

Company name
Lonza Group Ltd

Charleston, TN

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At Lonza, we invest in great people. We encourage our employees to challenge themselves and we offer an environment that fosters creativity and success. Headquartered in Basel, Switzerland, we operate production, R&D, and business sites around the world, including Europe, North America, and Asia.  Our vision : We strive to be the leading supplier using science and technology to improve the quality of life. Our mission : We work with passion, using advanced technologies, to transform life science into new possibilities for our customers.   Do you want to help us as we shape the future of this great organization? Job Description Summary Responsible for quality of all product manufactured at the Charleston site and for material produced at the Charleston site and packaged at third party manufacturers. Manages the Quality Department with responsibility for the effective testing of materials and products. Manages raw materials, product analysis, computer information systems, specifications, customer quality complaint investigations, department budget, and maintains the ISO 9001:2015 Quality Management System. Manages the Quality Department with responsibility for the effective testing of materials and products. Manages raw material quality release, product analysis, laboratory computer information systems, specifications, customer quality complaints, department budget, and maintains the ISO 9001 Quality Management System. Active member of the Charleston Plant Leadership Team. Primary Role & Responsibilities Manage the Quality Department resources to perform all required inspection and testing of raw materials, intermediates and finished goods to meet business needs Ensure Quality Department test methods, lab equipment maintenance\/repair, calibrations and record keeping are done in accordance with established procedures Support the development of data for Quality Control specifications for new products, optimizing existing specifications and test methods Ensure compliance with recognized international standards ISO 9001 Support validation of new\/revised test methods and\/or equipment , investigation of non-conformance issues and new product launch activities Represent the Charleston site as the ISO 9001 Management Representative Conduct quality audits at the plant and at suppliers Performs all necessary calculations and interprets results for subsequent action if necessary. Record test results, disposition of raw materials, intermediate and finished goods  Must be able to establish new analytical procedures using generally accepted experimentation procedures Manage and respond to customer product quality complaints, coordinate complaint investigations and implement corrective actions Manage Quality Department budget Independently prepare final reports based upon test results Consults with vendors and off-site analytical institutions regarding equipment functions and performance characteristics and analytical techniques Proficient performance of all routine and special assignments without direct supervision Utilize inter-personal skills in corresponding with operations, supervisors, coordinators, department managers, and engineers as required Provide support for the statistical analysis of data Quality Responsibility Maintenance of ISO 9001 certifications for the businesses by complying with processes, procedures and instructions for all activities in which this role participates Safety Responsibility Is knowledgeable of and complies with all pertinent safety policies, rules and regulations Skill Requirements Bachelor of Arts\/Science in Chemistry or Chemical Engineering ISO Internal\/Lead Auditor Training Individual should possess at least 5 years analytical and experimental experience in chemical manufacturing industry, and minimum of 1 year of applicable leadership experience Individual should possess some ISO 9001 knowledge and\/or experience. Work is carried out in a Quality Assurance and Research and Development laboratory. The position will involve project management as well as effective coordination and communication with Production, Engineering and Maintenance, Purchasing, Logistics, Packaging, and the Marketing and Sales Teams. Working knowledge of statistics and design of experiments Strong analytical skills Computer literacy with databases, word processing, spreadsheets using MS Office Suite; experience with SAP preferred Excellent organizational and communications skills Ability to clearly write and effectively present technical reports Qualified Quality Auditor Working Conditions Primarily Office Environment, however must qualify to observe production process and participate in plant inspections.This position must be able to assist in process troubleshooting by providing analytical support and data interpretation. Additional Info Relocation benefits may be available. Occasional (up to 10%) travel is required. Some non-standard work hours (e.g.: evening or weekend work) is required. Lonza is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a qualified individual with disability, protected veteran status, or any other characteristic protected by law.

Company info

Lonza Group Ltd
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Company Profile
Lonza is one of the world's leading and most-trusted suppliers to the Pharma&Biotech and Specialty Ingredient markets. We harness science and technology to create products that make people's and animals' lives healthier and that enhance the overall quality of life and well-being. Our products and services range from active pharmaceutical ingredients and stem-cell therapies to drinking water sanitizers, from industrial preservatives to microbial control solutions that combat dangerous viruses, bacteria and other pathogens, from the manufacture of vitamin B compounds and organic personal care ingredients to agricultural services and products. The company is organized into two market-focused segments: Pharma&Biotech and Specialty Ingredients. The core competencies that span these segments are advanced manufacturing and quality-control systems, superior regulatory expertise, in-depth market knowledge, and extensive technical customer-support and R&D capabilities.

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