QA & Compliance Specialist II (Lab Quality)

University of Rochester; United States; On-site; USD 35,000 - 49,000; Full time

Job summary

University of Rochester seeks a Quality & Compliance Professional to support the UR Medicine Labs division. You will implement quality programs, coordinate audits, and ensure adherence to federal/state regulations and industry standards across the department.

The role emphasizes developing QA plans, monitoring FPPE/OPPE processes, and maintaining records. Collaboration with multiple departments and external auditors is essential.

Qualifications

• 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.

Responsibilities

• Supports the quality and compliance program initiatives for UR Medicine Labs and affiliates.
• Coordinates audits, inspections, and monitoring visits from customers and regulatory agencies.
• Assists in development of quality assurance plans and procedures.
• Monitors department compliance with quality procedures.
• Maintains documentation and records in accordance with policy and guidelines.
• Assists with external audit schedules.

Skills

Quality Assurance

Regulatory Compliance

Audit Coordination

Data Analysis

Documentation

Education

Bachelor's degree in a related field

Or equivalent combination of education and experience

Laboratory experience preferred

Job description

University of Rochester seeks a Quality & Compliance Professional to support the UR Medicine Labs division. You will implement quality programs, coordinate audits, and ensure adherence to federal/state regulations and industry standards across the department.

The role emphasizes developing QA plans, monitoring FPPE/OPPE processes, and maintaining records. Collaboration with multiple departments and external auditors is essential.