QA/QC Manager
Greiner Bio One North America - Monroe, NC

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Greiner Bio-One North America, Inc., located in Monroe, North Carolina, provides product manufacturing, distribution logistics and product application support to our customers in Life Science and Clinical Laboratories through our BioScience and Preanalytic business units. The North American operation is a wholly-owned subsidiary of Greiner Bio-One International AG.Our BioScience operation offers products for the cultivation and analysis of cell and tissue cultures, microplates for high-throughput screening, a complete line of dependable ready-to-use general labware tools and innovative biochip technologies.The person is in charge of: Quality Assurance Preanalytics, Quality Assurance Bioscience, Chemical solution preparation, Laboratories, Microbiology and Hygiene Responsibilities Manages Quality control departments for Preanalytics and Bioscience to ensure quality standards, specifications, customer requirements and goals are achieved. Ensure compliance with applicable regulatory requirements, applicable standards and guidelines. Manage employees, materials and equipment for subordinate departments. Organizes Microbiology & Company hygiene program including verification and validation of product sterilization. Responsible for complaint evaluation and processing. Responsible for department costs and expense development. Manages department employee training program and organize company overall quality training program. Ensure qualification and validation of laboratory equipment and processes. Organize monthly inventory control in conjunction with Material Management Publish QM documents for area of responsibility. Periodic evaluation and reporting on external and internal quality data and trends for improvements. Periodic information exchange and evaluation of Quality trends with GBO Austria and GBO Frickenhausen. Train all employees on purpose and benefits of QM System and maintain awareness for quality program. Prepare yearly training schedules for the department and perform periodic employee reviews. Maintain positive work environment and work relation to other departments as well affiliated facilities. Other duties as assignedAuthority, competences Assignment of duties and responsibilities within department. Final judgment about quality status of products and on final product release. Manage internal Quality Audits and perform Supplier Audits. Publish QM documents for area of responsibility. Final judgment of complaints and quality irregularities in terms of quality aspects. Define quality criteria according to applicable standards and in cooperation with other departments and affiliated companies. Direct Microbiology & Company hygiene program including overall cleaning program. Direct complaints evaluation process. Selection of suppliers for laboratory equipment and supplies. Cooperation with external laboratories for product tests. Cooperation and communication with GBO Austria and GBO Frickenhausen. Approve expenses according to released budget. Employee selection and disciplinary actions up to termination for subordinated employees. Approval of laboratory equipment validation according to quality procedures.
Bachelor / Master Degree in Chemistry. 10 years QM experience in high volume manufacturing operations, with experience in medical device industry preferred. (Quality Assurance, Quality Control – Laboratory). 5 years experience with cGMP and FDA regulated industry. Multi-level Leadership Experience. Strong verbal and written communication skills (all levels). Solid Computer knowledge – Microsoft Office. Good knowledge in statistics and experience with statistical Software. Experience with Quality Management System according to ISO 9001 or ISO 13485 (preferred). Excellent Management and Organizational skills. Must pass pre-employment qualification exam. To apply, click Apply Now and you will be asked to create a Username and Password, then complete a 6 Step Job Application

CareerBuilder - 19 months ago - save job - block
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