Share Email Opening Title Quality Assurance Specialist, Leave Replacement   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 Specialist will be responsible for supporting projects and activities related to quality assurance which include but is not limited to quality improvement, quality training, laboratory audits, document control and other responsibilities of the Quality Assurance department. The Quality Specialist collects data retrieved from different sections for the laboratory to actively ensure the laboratory is inspection ready. This is a temporary leave replacement. This data will include: Facility management - laboratory safety, reagent management, instrument, and equipment stewardship Maintaining Human resources files as it relates to quality assurance Testing performance - pre-analytical, analytical, post-analytical phases Quality assurance - quality control processes, proficiency testing, turn-around time Referral laboratory performance Response to nonconformity and correction action documentation Responsibilities: Ensure compliance of all relevant personnel with CLIA, CAP, and NYSDOH requirements; assists with company's regulatory training program Ensure adherence of all relevant personnel to existing SOPs Assists with implementing and maintaining company's Quality Management System Identifies and resolves internal quality issues by working closely with the Director of QA Assist Quality Director with monthly and quarterly quality metric reports Schedule and conduct regular QA audits and inspections of assigned departments and facilities and perform audit reports Ensure complete and accurate readiness for all inspections Perform first level review of proficiency testing results Stay current with all regulatory agency and proficiency test requirements Serve as a resource on regulatory issues and compliance Assists with all pre-audit preparations; provides support during regulatory audits/inspections Assists with other Quality Assurance-related functions, as needed This is a temporary leave replacement   Position Requirements Educational Requirements: Bachelor of Science degree in Medical Technology or Medical Toxicology, Molecular Diagnostics, or other natural sciences discipline required ASCP or other national certification preferred ASQ certification a plus. Experience Requirements: Minimum 2 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. Required Skills: Possess working knowledge of Quality Management System principles and experience with basic QA functions Familiar with NYSDOH, CLIA, and CAP requirement. FDA 21 CFR Part 820 a plus Possesses excellent communication skills (written and verbal) Possesses xcellent critical thinking, analytical and problem solving skills Experienced in performing root-cause analysis of laboratory non-conformances and the determination of appropriate CAPAs Possesses basic auditing skills Possesses exceptional attention to detail and organizational skills Working knowledge of Microsoft Word, Excel and Outlook Ability to work autonomously and in a team-oriented environment 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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