QA&Compliance Spec II, Lab Med

University of Rochester•Town of Henrietta, NY

10d•$26 - $36•Onsite

About The Position

The University of Rochester is defined by a deep commitment to Meliora - Ever Better. Embedded in that ideal are the values we share: equity, leadership, integrity, openness, respect, and accountability. Together, we will set the highest standards for how we treat each other to ensure our community is welcoming to all and is a place where all can thrive. This position supports the quality and compliance program initiatives for the Division of Pathology and Laboratory Medicine. Following division quality/compliance standards and protocols, it ensures consistent quality/compliance programs and standards within the department. The role communicates and ensures enforcement of applicable federal and state regulatory requirements and industry standards to laboratory leadership and staff. It monitors department compliance with quality/compliance procedures and programs, collaborates with laboratory staff to promote regulatory compliance, and coordinates audits, inspections, and monitoring visits from customers and regulatory agencies.

Requirements

Bachelor's degree in a related field and 2 years of clinical, quality, or management experience required
Equivalent combination of education and experience

Nice To Haves

Laboratory experience and/or familiarity with the regulatory environment preferred

Responsibilities

Monitors the Quality Assurance and Compliance Program for UR Medicine Labs and affiliates.
Conducts internal audits, prepares audit reports, tracks internal audit responses, and monitors/documents action taken to correct all deficiencies at all sites.
Assists in the development of section-specific quality assurance/compliance plans and procedures.
Collaborates with internal departments to develop quality monitors in accordance with industry standards.
Monitors Focused Professional Practice Evaluation (FPPE) and Ongoing Professional Practice Evaluation (OPPE) programs.
Coordinates data submission and review of department standard metrics.
Evaluates and makes recommendations regarding audit outcomes, data analysis, and departmental key indicators, including Clinical Trials project-specific indicators.
Supports activities related to billing compliance, as needed.
Monitors occurrence management initiatives and assists staff in developing quality improvement plans.
Assists in the development of Corrective Action and Preventative Action (CAPA) plans.
Tracks the progress of CAPA/quality improvement initiatives.
Provides department management with regular updates on quality systems initiatives.
Participates in the development and execution of the UR Medicine Lab Quality and Compliance Plans.
Assists in the development of department policies and procedures.
Assists with the preparation of a yearly Quality and Compliance Report.
Monitors document management process, ensuring related documents and records are in accordance with UR Medicine Labs policy, state and federal guidelines.
Maintains documents and records according to protocol requirements and state and federal healthcare standards.
Assists with external audit schedules.
Tracks progress of corrective action plans related to audit findings.
Maintains current knowledge of developing trends in quality systems methods, state and federal regulations and incorporates such into department programs.
Researches state/federal regulations and current industry standards to provide guidance for compliance and best practices.
Conducts risk assessments of current processes against regulations and industry standards.
Performs other duties as assigned.