Senior Lab Quality & Compliance Specialist

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

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.