Acutis Diagnostics is headquartered in East Northport, Long Island. The company is a fast-growing clinical laboratory. We pride ourselves on providing expert, accurate, and concise results as a product of our highly talented and passionate team of professionals. We believe the team we build today will be the foundation of our future success.
We are looking for a Quality Assurance Manager who plans and directs activities concerned with development, implementation and maintenance of quality standards for laboratory processes, materials and products.
Coordinates the collection and cataloging of data retrieved from different sections for the laboratory to actively ensure the laboratory in a state of inspection readiness. This data will include quality assessment forms associated with:
The QA manager implements and provides oversight for the laboratory's QA program.
This individual will be self-directed in establishing and maintaining a quality assurance program that complies with regulatory guidelines established by NY State DOH CLEP, CLSI and FDA.
This individual works with laboratory leadership and staff to maintain compliance with all Federal and State laws, including NY state DOH CLEP standards.
This individual will work with laboratory leadership and staff in preparation for external and internal inspections.
This individual will help in the design, implementation and management the laboratory quality system to provide relevant outcomes data and information.
Works closely with the laboratory director to develop an effective Quality Assurance program
Maintains laboratory documentation to ensure traceability from state law to laboratory policies, to procedures, to quality assessment logs
Continuously evaluates incoming data to provide a long-term view of laboratory performance
Works closely with the laboratory director to develop, revise, implement and maintain standard operating procedures according to good laboratory practices
Works closely with the laboratory director in preparing for audits and inspections by any authorized agencies
Supervises the collection, cataloging and storage of QC documentation, method validations, lot-to-lot reagent comparisons, instrument and equipment maintenance
Conducts investigation of the test failures and procedure deviations
Bachelors in Medical Technology or natural sciences discipline required
Masters in natural sciences discipline preferred
5 - 10 years of prior experience in a clinical laboratory setting with increasing levels of responsibility
ASCP (American Society for Clinical Pathology) certified preferred
Excellent working knowledge of Microsoft Excel
Excellent written and verbal communication skills
Able to organize and prioritize workload
Able to think quickly and make decisions under pressure
Sitting for an extended period of time
Repetitive wrist motion
Audible recognition of alarms
Internal Number: 728
While our science and methodologies are among the most advanced in the industry, what distinguishes
our practice is a strong sense of obligation: We are obliged to provide reports that enable clients to act
with the highest degree of confidence.
State-of-the art instrumentation and technologies are employed to produce highly intuitive, proprietary reports. Each provides critical and unique information that allows physicians, clinicians, counselors, and others to possess the facts they require to make the best possible medical decisions … those that will produce the best outcomes, in the most timely fashion.
Our PhDs, senior scientists and certifying medical technologists, utilize robotics, automation, and sophisticated algorithms to turn samples, even of the smallest quantities of specimens, into actionable
While our investments in technology and innovation advance medication and drug monitoring and
toxicology reporting, what closes the circle is the ever-present sense of obligation. Toward that end,
we combine hard science with the soft skills practiced by our support staff and sales specialists.
Rigorous technological processes and practices are only fully... realized when their benefits are accessible
to every member of the team. We have built a company with no gaps. No bureaucracy. No insurmountable hierarchy. From our CEO engaged in strategic planning and our senior scientists in the lab, to sales specialists on the road, every employee is fully accountable. Fully accessible. Completely willing to assume responsibility. Which is why we can say: Acutis = Accuracy ®