Quality Systems Auditor

LifeNet Health•Virginia Beach, VA

35d•$57,363 - $95,605

About The Position

The Quality Systems Auditor performs all aspects of internal quality audits, including planning, initiation, observations, interviews, analysis, reporting, verification of corrective and preventive actions, and maintenance of audit files. The position assists with audits of tissue suppliers and distribution intermediaries and supports third-party audits conducted by regulatory agencies and business partners. It also provides guidance for LifeNet Health’s Zone Assessment Program. The role leads cross-functional projects, promotes problem-solving methods such as 8D, and creates and revises standard operating procedures to meet QSR/GTP, AATB, and ISO requirements. The auditor reviews CAPA investigations for completeness and effectiveness, serves as a technical resource for CATSWeb activities, and provides training as needed.

Requirements

Two years of experience with a degree, or six years without a degree, in quality- or operations-related activities in tissue banking, blood banking, medical devices, clinical trials, or pharmaceuticals.

Responsibilities

Plan and conduct internal quality audits, including initiation, observations, interviews, analysis, and reporting.
Verify corrective and preventive actions and maintain audit files.
Assist with audits of tissue suppliers and distribution intermediaries.
Support third-party audits by regulatory agencies and business partners.
Provide guidance for the Zone Assessment Program.
Lead cross-functional projects.
Promote problem-solving methods such as 8D.
Create and revise SOPs to meet QSR/GTP, AATB, and ISO requirements.
Review CAPA investigations for completeness and effectiveness.
Serve as a technical resource for CATSWeb activities.
Provide training as needed.