Sr Quality & Compliance Spec

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 URG 112

Compensation Range:

$70,600.00 - $105,800.00

Responsibilities:

Identifies the need for and conducts audits of internal processes to ensure compliance with policy and regulations. Develops and maintains relationships with regulatory commissions/authorities. Coordinates the assessment of internal controls to ensure compliance as required by regulatory commissions/authorities. Develops programs and processes to manage complaint cases brought to regulatory authorities and recommends process improvements to avoid future complaints. Prepares reports for leadership on compliance and quality metrics, evaluates and provides insight to support continuous improvement. May train and/or coach staff and management. Develops programs and processes to manage complaint cases brought to regulatory authorities and develops process improvements to avoid future complaints. Mentors more junior team members.

ESSENTIAL FUNCTIONS

• Collaborates and guides development of work processes to meet departmental needs and industry standards. Develops QA response and prepares exhibits as needed. Conducts internal quality audits, prepares reports, tracks responses and monitors/documents corrective action taken. Evaluates and makes recommendations regarding audit outcomes, data analysis and departmental key indicators.
• Interacts with Medical Center QA and Process Improvement teams regarding quality initiatives and root cause analysis, as assigned. Reviews documents for compliance. Develops and monitors protocol specific quality assurance plans, if required, based on position/department. May develop, manage and monitor external vendor assessment program. Reviews and/or approves procedures, validation plans and other quality related documents, as applicable.
• Manages external audit schedules and facilitates quality audits by external parties. Communicates with auditors to establish audit objectives/time frames. Coordinates interviews/provides documentation. Prepares QA responses to audit findings and coordinates responses.
• Oversees occurrence management initiatives and assists staff in developing quality improvement plans. Directs development and tracks progress of Corrective Action and Preventative Action (CAPA) plans. Provides department management with regular updates on quality systems initiatives. Analyzes data within the occurrence management system for trends.
• Researches and maintains current knowledge of developing trends in quality systems methods and state and federal regulations and incorporates best practices into department programs. Conducts risk assessments against regulatory/industry standards. Develops and monitors document management process, ensuring related documents and records are in accordance with departmental and UR policy, state and federal guidelines. Maintains QA documents and records according to standards.
• Other duties as assigned.

MINIMUM EDUCATION & EXPERIENCE

• Bachelor's degree and 5 years relevant experience required
• Or equivalent combination of education and experience

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.