Quality Assurance (QA) Auditor

CSSDurham, NC
Hybrid

About The Position

We are seeking a Quality Assurance (QA) Auditor to support our federal contract with the National Institute of Environmental Health Sciences (NIEHS). The QA Auditor will ensure the accuracy, integrity, and compliance of toxicological research studies, with a focus on rodent models (mice and rats). This position requires strong auditing and QA skills, scientific knowledge of toxicology studies, and proficiency with technology, including modern tools such as AI. The successful candidate will be independent, accountable, and able to deliver polished, GLP-compliant audit reports that meet contract deadlines with minimal oversight, while also collaborating effectively with internal staff and NIEHS stakeholders.

Requirements

  • Minimum bachelor's degree in a scientific field (Toxicology, Biology, Chemistry, Environmental Health, or related discipline).
  • Demonstrated experience through undergraduate training and/or professional work in Quality Assurance, Regulatory Compliance, and/or Laboratory Research, ideally with a focus on toxicology studies.
  • Working knowledge of rodent (mice/rat) study design, conduct, and interpretation.
  • Familiarity with Good Laboratory Practices (GLP) and regulatory QA processes.
  • Strong proficiency with Microsoft Office Suite (Word, Excel, PowerPoint, Outlook).
  • Ability to work effectively on both Windows and Mac operating systems, and troubleshoot basic technology issues independently.
  • Basic understanding of AI tools and applications relevant to auditing, data verification, or document review.
  • Excellent written and verbal communication skills.
  • Strong attention to detail with the ability to work independently, manage multiple audit assignments, and meet deadlines without extensive oversight.
  • U.S. citizenship or permanent resident status required.
  • Must be able to obtain and maintain a National Agency Check (NAC) or equivalent federal background clearance required for access to NIEHS/NTP systems.

Nice To Haves

  • Experience auditing toxicology reports or laboratory data in a QA role.
  • Familiarity with Provantis, CEBS, or NELI data systems.
  • Previous experience with federal contracts or regulatory agencies (EPA, FDA, NIEHS, NTP, or OECD).
  • Experience utilizing AI tools to support auditing workflows, data analysis, or QA documentation.

Responsibilities

  • Conduct QA audits of toxicology study reports, laboratory data, pathology tables, electronic records, and related documents to ensure compliance with Good Laboratory Practices (GLP), NIEHS/NTP guidelines, and federal contract requirements.
  • Review experimental design, methods, and study conduct, with emphasis on rodent (mice/rat) toxicology studies.
  • Verify accuracy and consistency between raw data (e.g., Provantis, CEBS, NELI) and final report outputs.
  • Identify, document, and communicate discrepancies through clear audit reports.
  • Ensure audit deliverables consistently meet federal timelines, formatting, and technical standards.
  • Collaborate with staff/colleagues and government officers/employees to address findings and resolve issues constructively.
  • Apply technology and AI tools to enhance auditing efficiency, documentation, and reporting processes.
  • Maintain strict attention to confidentiality, accuracy, and data integrity.
  • Participate in internal SOP reviews, process improvements, and team training as required.

Benefits

  • NIEHS-issued Mac laptop and secure network credentials will be provided for contract work.
  • Standard office and computer equipment will also be supplied as needed (e.g., monitors, peripherals).
  • Training provided for data verification tools such as Provantis, CEBS, or NELI.
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