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Regulatory amp Quality Compliance Manager

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Atlanta, GA

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nnJob DescriptionnEGL Genetics Laboratory is owned by Eurofins and is one of the leading diagnostic genetic laboratories in North America. EGL, with three comprehensive laboratories providing cytogenetic, biochemical, and molecular genetic testing, has been a worldwide leader in comprehensive genetic diagnostic testing for more than 35 years. EGL has extensive expertise in genetic testing for rare diseases, metabolic diseases, autism, intellectual disabilities, and congenital disorders of glycosylation. EGL Genetic Diagnostics LLC is searching for a Regulatory and Quality Compliance Manager in Tucker, GA. The Regulatory and Quality Compliance Manager responsibilities include, but are not limited to, the following: nLead the quality and regulatory initiative for EGL to comply with CLIA, State of GA, CAP, State of NY and State of FL regulations. Be familiar with ISO regulations. Coordinate all quality assurance (QA) activities for the laboratory, interpret regulatory requirements for the department, and apply consistent regulatory standards throughout the laboratory departments. Oversee performance improvement plan and identify, develop and implement strategies that result in improvement of best lab utilization practice and patient outcomes. Lead all client audits and regulatory agency inspections as well as formal responses to their findings/recommendations. Investigate and take action to resolve quality assurance and regulatory complaints or incidents. Perform audits and review of systems and processes to ensure adherence to quality assurance plans. Prepare written audit reports and present management briefings within specified time periods. Oversee internal inspections to determine compliance with certification requirements, laws, regulations, policies and procedures. Recommend corrective actions to address non-conforming practices, which are identified in audits and inspections. Monitor implementation of corrective actions. Review and revise QA documents. Review and approve general standard operations procedures. Verify analytical and regulatory requirements as needed to ensure that quality assurance documents and SOP's are in compliance with current regulations. Review pertinent publications to stay abreast of the regulatory and quality developments within clinical lab industry. Develop SOP formats and maintain control of documents. Provide training to site employees in Inspection Readiness activities and regulatory guidelines; provide new employee orientation to quality management processes. Serve as the HIPAA Privacy Compliance Officer with responsibility of medical records release policies and procedures. Assure method validation protocols, validation repots, test methods, general lab protocols and standard operating procedures are reviewed to assure regulatory compliance. The ideal candidate would possess: nStrong computer, scientific, and organizational skills Excellent communication (oral and written) and attention to detail Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude Ability to learn new processes, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies Strong leadership, initiative, and team building skills Basic Minimum Qualifications: nBachelor of Science Degree in a pertinent scientific discipline is required. ASCP registration (current or former) or equivalent. Requires ten years' experience in Clinical Laboratory Science with a minimum of 5 years in Quality/Regulatory area and/or focus on quality improvement and service excellence. Minimum of three years' experience in a management/supervisory capacity. Skills and aptitudes needed: Listening, problem solving, prioritization, attention to detail, organization and time management, excellent written and oral communications, planning and evaluation, and resource management Authorization to work in the United States indefinitely without restriction or sponsorshipPosition is full-time, Monday - Friday 8:30am-5:00pm with overtime as needed. Candidates currently living within a commutable distance of Tucker, Georgia are encouraged to apply. As a Eurofins employee, you will become part of a company that has received national recognition as a great place to work. We offer excellent full-time benefits including comprehensive medical coverage, life and disability insurance, 401(k) with company match, paid holidays and vacation, personal days, and dental and vision options. To learn more about Eurofins, please explore our website ****Eurofins is a M/F, Disabled, and Veteran Equal Employment Opportunity and Affirmative Action employer.

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