Quality Assurance and Regulatory Manager

Schedule: Full-Time

POSITION: Quality Assurance and Safety Manager

LOCATION: Laboratory Alliance of CNY; Syracuse, NY 13212

SHIFT:  1st Shift / Full or Part - Time

ABOUT US: Laboratory Alliance is the area’s largest state-licensed laboratory, providing clinical and anatomic pathology testing to a 16-county region in Central New York. As the laboratory of choice for most local healthcare providers, more than 10 million tests are performed annually at our laboratories at our Operations Center in Liverpool and at Crouse Hospital in Syracuse, N.Y.

We are an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

POSITION DESCRIPTION:

Under the direction of the Human Resource Director, the Quality Assurance and Regulatory Compliance Manager oversees the clinical laboratory quality assurance and corporate compliance programs, proficiency testing, occurrence reporting, and regulatory agency inspections and accreditations.

POSITION RESPONSIBILITIES:

Design and implement quality improvement monitors and participate in performance improvement activities; monitor compliance of quality control documentation, corrective action and appropriate supervisory signatures in compliance with New York State Department of Health recommendations and requirements; coordinate proficiency testing program with the laboratory director and monitor result submission, result review and corrective action for all proficiency testing failures; assist the laboratory director in maintaining a personnel competency program that includes technologists and supervisory personnel as per directives of the medical directors; ensure the laboratory has proper policies and procedures to comply with the New York State Department of Health, the Centers for Medicare and Medicaid Services, the Department of Health and Human Services, and any other federal or state regulatory agency requirements; facilitate compliance and privacy programs including developing and maintaining compliance and HIPAA privacy policies and procedures; investigate and track incidents and breaches and ensure protection of patients’ rights in compliance with federal and state laws; manage a strategic and comprehensive privacy program that defines, develops, maintains, and implements policies and processes; attend all regulatory agency inspections and provide summary of deficiencies and recommendations for improvement; maintain up to date knowledge of regulatory changes; perform other duties as required.

REQUIREMENTS/QUALIFICATIONS:

• Bachelor’s degree in medical technology, clinical laboratory science and/or national certification in clinical laboratory science preferred
• Extensive knowledge of laboratory regulations, including the New York State Department of Health, the Centers for Medicare and Medicaid Services, and the Department of Health and Human Services
• 3-5 years of relevant experience overseeing clinical laboratory quality assurance and regulatory compliance programs

WORK ENVIRONMENT AND HAZARDS:

The work environment frequently varies based on tasks with low exposure to communicable diseases, bloodborne pathogens, toxic substances, and other conditions common to a healthcare environment.

PHYSICAL DEMANDS:

The  physical  demands  are  representative  of  demands  that  must  be  met  by  an  employee  to  successfully perform  the  essential  functions  of  this  job.  Reasonable  accommodations  may  be  made  to  enable  individuals  with disabilities  to  perform  the  essential  functions. The employee is regularly both stationary and required to move about. May frequently be required to operate a computer and other office equipment and/or a vehicle for extended periods, and frequently exchange accurate information with other staff and vendors in person and over the phone.  Ability to determine and detect differences in size, color, numbers, and letters, move about from location to location which may require traversing stairs, uneven surfaces both indoor and outdoor in all forms of weather,  and have the ability to transport up to 10 pounds and occasionally transport up to 30 pounds.

SKILLS AND OTHER REQUIREMENTS:

Strong organization, problem solving, and interpersonal communication skills required. Self-motivated, eager to learn, attention to detail, and team oriented.

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