Talent.com
Quality Assurance (QA) Auditor
Quality Assurance (QA) AuditorCSS, Inc • Durham, NC, USA
Quality Assurance (QA) Auditor

Quality Assurance (QA) Auditor

CSS, Inc • Durham, NC, USA
Hace 21 días
Tipo de contrato
  • Indefinido
  • Quick Apply
Descripción del trabajo

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 (
  • 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.

    Crear una alerta de empleo para esta búsqueda

    Quality Assurance Auditor • Durham, NC, USA

    Ofertas relacionadas
    Director of Quality Assurance

    Director of Quality Assurance

    Insight Global • Durham, NC, US
    A tiempo completo
    Bachelor's Degree with 12+ years of experience OR Master's Degree with 10+ years of experience in a QA or GMP environment. Experience in a QA role supporting validation, engineering, IT and change c...Mostrar más
    Última actualización: hace 2 días • Oferta promocionada
    Quality Control Auditor

    Quality Control Auditor

    Brighton Health Plan Solutions, LLC • Chapel Hill, NC, US
    A tiempo completo
    Quick Apply
    About The Role The Quality Control Auditor, objectively, systematically, and continuously assesses, assures monitors, evaluates, and improves the quality of processes and services provided based on...Mostrar más
    Última actualización: hace 2 días
    Quality Assurance Manager (1790)

    Quality Assurance Manager (1790)

    Kooner Fleet Management Solutions • Durham, NC, US
    A tiempo completo
    About Kooner Fleet Management Solutions.Kooner Fleet Management Solutions is one of the fastest-growing national providers of on-site fleet maintenance, preventative service, and mobile repair solu...Mostrar más
    Última actualización: hace 9 días • Oferta promocionada
    Quality Assurance Specialist

    Quality Assurance Specialist

    Globalchannelmanagement • Morrisville, North Carolina, United States
    A tiempo completo
    Quality Assurance Specialist needs 3 years of experience in the biotech / pharmaceutical industry within research and development or commercial organizations. Quality Assurance Specialist requires : .GM...Mostrar más
    Última actualización: hace más de 30 días
    Quality Assurance Associate

    Quality Assurance Associate

    Meet Life Sciences • Raleigh, NC, US
    A tiempo completo
    GMP, regulatory, and company quality standards.This role supports batch record review, deviation management, and quality oversight of production operations to maintain product integrity and complia...Mostrar más
    Última actualización: hace 2 días • Oferta promocionada
    PT Quality Assurance Associate

    PT Quality Assurance Associate

    Food Lion • Raleigh, NC, US
    A tiempo completo
    Food Lion has been providing an easy, fresh and affordable shopping experience to the communities we serve since 1957.Today, our 82,000 associates work in stores and distribution centers across the...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Quality Assurance Lead 1.19

    Quality Assurance Lead 1.19

    Focused HR Solutions • Raleigh, North Carolina, United States
    A tiempo completo
    Quick Apply
    M-2 650718 - IT Quality Assurance Lead - Raleigh, NC.Candidates will be allowed to work remotely during COVID.Once restrictions are lifted and the client’s office opens, candidates will be re...Mostrar más
    Última actualización: hace más de 30 días
    Assurance Manager

    Assurance Manager

    Dean Dorton • Raleigh, NC, United States
    A tiempo completo
    Dean Dorton's team makes up one of the largest advisory firms in the United States.We thrive when you thrive! We are here to help you succeed in every step of your development and career as you wor...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Director, Clinical Quality Assurance

    Director, Clinical Quality Assurance

    Eisai • Durham, NC, United States
    A tiempo completo
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...Mostrar más
    Última actualización: hace 11 días • Oferta promocionada
    Director, Quality Assurance

    Director, Quality Assurance

    North Carolina Staffing • Durham, NC, US
    A tiempo completo
    For more than 100 years, Novo Nordisk has been tackling the unmet medical needs of people living with serious chronic diseases, such as diabetes and obesity. Being part of Novo Nordisk allows our em...Mostrar más
    Última actualización: hace 10 horas • Oferta promocionada • Nueva oferta
    Audit Sr Advisor - Corporate

    Audit Sr Advisor - Corporate

    First Horizon Bank • Raleigh, NC, United States
    A tiempo completo
    On site at locations listed Memphis, TN, Birmingham, AL, Dallas, TX, Lafayette, LA, New Orleans, LA, Charlotte, NC, Raleigh, NC, Atlanta, GA, Miami, FL. Primarily responsible for completing audit en...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Specialist Quality Assurance III

    Senior Specialist Quality Assurance III

    Spectraforce Technologies • Durham, NC, United States
    A tiempo completo
    Senior Specialist Quality Assurance III.Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years e...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Quality Improvement Abstractor

    Quality Improvement Abstractor

    Spectraforce Technologies • Raleigh, NC, United States
    A tiempo completo
    Title : Quality Improvement Abstractor.Will be required to complete training / testing on HEDIS measures (3 attempts).Will perform independent review of medical records and abstract and overread based...Mostrar más
    Última actualización: hace más de 30 días • Oferta promocionada
    Senior Quality Assurance Specialist - (Biotech)

    Senior Quality Assurance Specialist - (Biotech)

    Nesco Resource • Durham, NC, US
    A tiempo completo
    Preferred experience in the assessment and preparation of manufacturing sites for Pre-Approval inspections by Regulatory agencies for new products. Must have strong demonstrated interpersonal, commu...Mostrar más
    Última actualización: hace 2 días • Oferta promocionada
    Senior Quality Assurance Specialist

    Senior Quality Assurance Specialist

    Integrated Resources, Inc ( IRI ) • Durham, NC, US
    A tiempo completo
    Quality Assurance professional with at a minimum a BS Biology, Microbiology, Pharmacy, Chemistry, Chemical Engineering (or equivalent) and at least 5 years experience in the Pharmaceutical Industry...Mostrar más
    Última actualización: hace 2 días • Oferta promocionada
    Quality Assurance Auditor Crop Protection

    Quality Assurance Auditor Crop Protection

    knoell • Durham, North Carolina, United States
    A tiempo parcial
    Quick Apply
    Quality Assurance Auditor Crop Protection at knoell | softgarden.Quality Assurance Auditor Crop Protection.Join Us in Shaping the Future of Regulatory Services. As a family-owned business, we take p...Mostrar más
    Última actualización: hace 10 días
    Quality Assurance Specialist

    Quality Assurance Specialist

    Mentor Technical Group • NC, US
    A tiempo completo
    Quick Apply
    Mentor Technical Group (MTG) provides a comprehensive portfolio of technical support and solutions for the FDA-regulated industry. As a world leader in life science engineering and technical solutio...Mostrar más
    Última actualización: hace más de 30 días
    Director, Quality Assurance Value Chain Management (Global, Hybrid)

    Director, Quality Assurance Value Chain Management (Global, Hybrid)

    Merck • Durham, NC, US
    A tiempo completo
    We're looking for a Director of Quality Assurance to lead quality across the full value chain for a late-stage ophthalmic program. In this role, you'll be a core member of the Value Chain Management...Mostrar más
    Última actualización: hace 2 días • Oferta promocionada