QA&Compliance Spec II, Lab Med

University of Rochester Medicine; Town of Henrietta (NY); On-site; USD 36,000 - 50,000; Full time

Job summary

University of Rochester Medicine is seeking a Quality & Compliance Specialist to support the Division of Pathology and Laboratory Medicine. The role ensures adherence to federal and state requirements, conducts internal audits, and coordinates external inspections across UR Medicine Labs and affiliates.

Responsibilities include monitoring quality systems, developing CAPA plans, and communicating regulatory expectations to leadership and staff to sustain compliant operations.

Qualifications

• Bachelor's degree in a related field and 2 years of clinical, quality, or management experience required.
• Laboratory experience and/or familiarity with regulatory environments preferred.

Responsibilities

• Monitors Quality Assurance and Compliance Program for UR Medicine Labs and affiliates. Conducts internal audits and tracks corrective actions.
• Monitors occurrence management initiatives and assists staff in developing quality improvement plans.
• Coordinates audits, inspections, and monitoring visits from customers and regulatory agencies.
• Maintains current knowledge of developing trends in quality systems and regulations.

Skills

Quality Assurance

Regulatory Compliance

Audits

Education

Bachelor's degree in related field

Job description

As a community, 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.

Job Location (Full Address)

211 Bailey Rd, Rochester, New York, United States of America, 14586

Opening

Worker Subtype: Regular

Time Type

Full time

Scheduled Weekly Hours

40

Department

500240 Lab Admin-Clin Labs SMH

Work Shift

UR - Day (United States of America)

Range

UR URC 209 H

Compensation Range

$25.60 - $35.84

The referenced pay range represents the minimum and maximum compensation for this job. Individual annual salaries/hourly rates will be set within the job's compensation range, and will be determined by considering factors including, but not limited to, market data, education, experience, qualifications, expertise of the individual, and internal equity considerations.

Responsibilities

Supports the quality and compliance program initiatives for the Division of Pathology and Laboratory Medicine. Following division quality/compliance standards and protocols, ensures consistent quality/compliance programs and standards within the department. Communicates and ensures enforcement of applicable federal and state regulatory requirements and industry standards to laboratory leadership and staff. Monitors department compliance with quality/compliance procedures and programs. Collaborates with laboratory staff to promote regulatory compliance. Coordinates audits, inspections, and monitoring visits from customers and regulatory agencies.

Essential Functions

• Monitors 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. Support 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 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 health care standards.
• Assists with external audit schedules. Tracks progress of corrective action plans related to audit finding.
• 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.
• Other duties as assigned.

Minimum Education & Experience

• Bachelor's degree in a related field and 2 years of clinical, quality, or management experience required
• Or equivalent combination of education and experience
• Laboratory experience and/or familiarity with the regulatory environment preferred

The University of Rochester is committed to fostering, cultivating, and preserving an inclusive and welcoming culture to advance the University’s Mission to Learn, Discover, Heal, Create – and Make the World Ever Better. In support of our values and those of our society, the University is committed to not discriminating on the basis of age, color, disability, ethnicity, gender identity or expression, genetic information, marital status, military/veteran status, national origin, race, religion, creed, sex, sexual orientation, citizenship status, or any other characteristic protected by federal, state, or local law (Protected Characteristics). This commitment extends to non-discrimination in the administration of our policies, admissions, employment, access, and recruitment of candidates, for all persons consistent with our values and based on applicable law.