Quality Assurance Auditor

Job Title:

Quality Assurance Auditor Job Description

The Quality Assurance Auditor supports Good Laboratory Practice (GLP) compliance across nonclinical laboratory studies in an animal-focused contract research environment. This role works closely with Quality Assurance, Study Directors, Scientists, and Laboratory Management to ensure that study conduct, documentation, and reporting activities consistently meet FDA and EPA GLP regulations. The position focuses on auditing regulated studies and data, inspecting facilities, and supporting regulatory inspection readiness in toxicology, pharmaceutical, medical device, and related laboratory settings, contributing to research that helps advance cancer therapies.

• Perform quality assurance activities in accordance with FDA and EPA Good Laboratory Practice (GLP) regulations for nonclinical laboratory studies.

• Conduct in-process inspections of regulated laboratory studies to verify adherence to study protocols, SOPs, and GLP requirements.

• Perform facility inspections within toxicology, chemistry, and laboratory operations to assess compliance and identify areas for improvement.

• Monitor ongoing study conduct to ensure procedures, documentation, and reporting align with approved protocols and internal quality standards.

• Maintain audit schedules, inspection plans, and related documentation to support a structured and consistent QA program.

• Support quality investigations and compliance improvement initiatives by documenting findings, tracking actions, and following up on resolutions.

• Audit raw data, laboratory records, notebooks, worksheets, and supporting documentation for accuracy, completeness, and traceability.

• Review study reports and data tables to confirm that reported results are consistent with source data and meet documentation requirements.

• Compare final study reports against source documentation to verify data integrity and alignment with protocol and SOP requirements.

• Verify that study documentation complies with protocol requirements, internal procedures, and GLP expectations before final approval.

• Assist in reviewing corrections and report revisions, ensuring appropriate documentation and justification prior to final sign-off.

• Assist during client, FDA, EPA, and other regulatory inspections by preparing materials, responding to information requests, and supporting inspection activities.

• Gather, organize, and prepare supporting documentation and quality records for auditors and regulatory inspectors.

• Maintain organized QA files and quality records to ensure they are complete, accurate, and readily available for internal and external review.

• Support internal inspection readiness initiatives and quality system maintenance to keep the organization prepared for audits and regulatory visits.

• Participate in continuous improvement activities aimed at strengthening compliance programs and enhancing overall quality systems.

• Review, update, revise, and control Standard Operating Procedures (SOPs) to reflect current practices and regulatory expectations.

• Maintain quality records and audit documentation in accordance with established documentation practices and data integrity principles.

• Ensure all quality records are complete, accurate, traceable, and inspection-ready, supporting robust GLP compliance.

• Support quality systems documentation and record retention activities to meet regulatory and internal requirements.

• Collaborate with laboratory teams working on toxicology and biocompatibility studies, including those involving medical devices.

• Understand testing workflows for medical devices, such as preparing extractions from devices to be dosed to animals, determining relevant surface areas, and ensuring appropriate handling of device components.

• Work with teams that perform GLP in vitro studies, including genetic mouse toxicology and cell culture-based assays, to understand study design and documentation needs.

• Use cell culture techniques and fluorescent microscopy data review as part of study and data auditing, including reading slides and evaluating assay documentation.

• Minimum of 2+ years of experience working in a GLP-regulated environment.

• At least 3+ years of experience auditing GLP studies and data, including nonclinical laboratory studies.

• Direct experience in a contract research organization (CRO), toxicology, pharmaceutical, medical device, or similar laboratory environment.

• Hands‑on experience auditing regulated laboratory studies, reviewing raw data, and…