Share Email Opening Title Quality Assurance Manager  About the Organization Acutis (www.Acutis.com) is a specialized medical laboratory that complements its hard science with the soft skills of its support teams. This combination allows practitioners to diagnose and treat with greater confidence and with ease. Acutis serves the medical community and related fields by providing rapid, reliable diagnostic insights that impact clinical decisions in: -infectious disease -clinical toxicology for substance use testing and medication monitoring -oncology We are a biomedical specialty laboratory that has no tolerance for error. A company as thorough as it is principled: dedication to the advancement of medical testing, industry-leading turnaround time, and world-class service. Every sample we take and every report we relay is prepared with this end in mind: to provide our customers with the highest level of certainty possible. With a service-first mindset, specialized laboratory capabilities, and the agility to adapt as next-generation therapies evolve, Acutis stands at the Service of Science. Additionally, building on our platform of advanced science and technology, we have introduced to healthcare professionals to Acutis Reveal™, molecular tests for infectious diseases. These new tests offer physicians and clinicians a greater degree of certainty than any standard or traditional test can. These new products offer further evidence of Acutis' passion for innovative technologies and strategies. Acutis conducts pioneering research for diagnostic services. We employ NGS, targeted PCR, LC-MS/MS, enhanced microbiology techniques and algorithm-based software to develop new diagnostic solutions.   EOE Statement We are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability status, protected veteran status or any other characteristic protected by law.   Description The Quality Assurance Manager oversees all quality assurance activities in the Hicksville, NY and Monmouth Junction, NJ laboratories’ they will provide leadership by communicating and achieving department objective; Hicksville will be the primary work location although travel to New Jersey will be required. This role will report directly to the Director of Quality Assurance. Communicate and maintain a quality management program to meet regulatory requirements of all standards and identify quality processes set forth by state, federal, licensing and accreditation agencies including CAP, CLIA, NYSDOH, FDA Part 820. Manage the daily activities and monitor the daily workflow in the QA department. Collaborate with the upper management team to set quality benchmarks. Follow up on all quality assurance/quality management issues. Supervise staff: hire, train, discipline, and supervise staff in collaboration with the leadership; evaluates performance and ensures appraisals are completed on a timely basis. Maintain laboratory documentation to ensure traceability. Brainstorm ideas to increase productivity and performance of direct reports. Consult with lab supervisors and managers in developing improvement initiatives. Collect and store documents supporting proper validation of the reagents, supplies and equipment. Conduct investigations of the test failures and procedure deviations. Promote the continuing Quality Improvement efforts of the laboratory. Facilitate successful completion of proficiency testing events and corrective actions. Support Quality Assurance activities related to the development, implementation and maintenance of document control and change control. Foster a culture of compliance and quality. Shift Information: Monday – Friday, 9AM – 5PM, shifts extend until work is completed Occasional weekends   Position Requirements Education Requirements: Bachelors’ in medical technology, Molecular Biology, Biotechnology, or related field Masters in natural sciences discipline, preferred. ASCP or other national certification, preferred. ASQ certification a plus. Experience Requirements: Minimum 4 years of direct Quality Assurance experience in a regulated laboratory environment (preferably clinical laboratory medicine). Five years’ experience as a Technologist/Technician working in a CLIA laboratory or equivalent experience. Skills Requirements: Possess working knowledge of Quality Management System principles and experience with QA functions. Familiar with NYSDOH, CLIA, and CAP requirement. FDA 21 CFR Part 820 a plus. Possess excellent communication skills (written and verbal). Possess strong leadership and management skills. Possess excellent critical thinking, analytical and problem-solving skills. Experience in performing root-cause analysis of laboratory non-conformances and the determination of appropriate CAPAs. Possess auditing skills. Possess exceptional attention to detail and organizational skills. Working knowledge of Microsoft Word, Excel, and Outlook. Able to positively influence others. Great team player with strong interpersonal skills. Ability to work autonomously and develop interdepartmental teams. Physical Requirements: Standing or sitting for an extended period Able to lift 25 lbs. Repetitive wrist motion Audible recognition of alarms   Full-Time/Part-Time Full-Time   This position is currently not accepting applications. 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