QA&Compliance Spec II, Lab Med

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.

Responsibilities

Supports the quality and compliance program initiatives for the Division of Pathology and Laboratory Medicine; 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; Conducts internal audits and prepares audit reports; Tracks corrective actions and quality improvement initiatives; Maintains document management process; Other duties as assigned

Requirements

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

Nice to have

Laboratory experience and/or familiarity with the regulatory environment