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.
Key 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.
Qualifications
Required:
- 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.
Preferred:
- 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.
Key Competencies
- Analytical, detail-oriented, and scientifically grounded.
- Independent and accountable in managing workload and producing audit-ready deliverables.
- Technologically adaptable, with a willingness to learn and apply new digital and AI-based platforms.
- Strong communicator able to collaborate across internal teams and with NIEHS staff.
- Committed to delivering high-quality, GLP-compliant QA products that support NIEHS/NTP's mission in public health.
Work Authorization, Government Agency Clearance, and Security Clearance Requirements
- 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. • NIEHS will provide onboarding and security training during system access initiation. • No visa sponsorship (e.g., H1-B) is available for this position.
Pre-Employment Requirements
- Employment is contingent upon successful completion of a background check, which may include verification of education, employment history, and references. • NIEHS will conduct a National Agency Check prior to granting network and facility access. • A drug screening may be required in accordance with company and federal guidelines. • NIEHS will provide mandatory onboarding and orientation training upon assignment to the contract.
Equipment Needed
- 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). • The position requires use of Microsoft Office Suite, Adobe Acrobat Professional, and data verification tools such as Provantis, CEBS, or NELI (training provided). • No vehicle or specialized physical equipment is required for normal duties.
Physical & Mental Requirements
This position primarily involves computer and desk-based work. The employee should be able to remain in a stationary position for extended periods, operate standard office equipment, and occasionally move about the office to access files or attend meetings. Light lifting of up to 15 pounds may be required. The role requires the ability to focus on detailed tasks, manage multiple priorities, make sound decisions, and communicate effectively. Adaptability, professionalism, and sound judgment are essential. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions of this position.
Working Environment
- Hybrid environment: combination of remote and on-site work at the NIEHS campus in Research Triangle Park, NC. • On-site attendance is occasionally required for meetings, audits, and collaborative activities with NIEHS and CSS team members.
Travel Required
- Minimal travel (<10%) may be required, primarily for training, meetings, or audits conducted at NIEHS or contractor facilities.
At CSS, we are committed to fostering an inclusive and merit-based workplace. We provide equal employment opportunities to all individuals, ensuring that hiring and employment decisions are based on qualifications, skills, and performance. We do not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.