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.
Responsibilities
- 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.
Essential Skills
- 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 conducting facility inspections.
- Strong understanding of FDA GLP regulations (21 CFR Part 58) and EPA GLP regulations.
- Demonstrated experience reviewing laboratory documentation and scientific records for accuracy, completeness, and compliance.
- Solid knowledge of documentation practices and data integrity principles within a regulated laboratory setting.
- Experience supporting regulatory inspection readiness activities, including preparation for FDA, EPA, and client audits.
- Ability to interpret and apply GLP requirements to study conduct, documentation, and reporting processes.
- Strong attention to detail and organizational skills to manage audit schedules, documentation, and multiple concurrent studies.
- Ability to work collaboratively with Quality Assurance, Study Directors, Scientists, and Laboratory Management.
- Experience with toxicology and biocompatibility studies, including those involving medical devices.
- Ability to understand and review workflows involving medical device testing, such as extraction preparation and surface area determination.
- Comfort working in environments that involve animal studies and nonclinical research.
- Effective written and verbal communication skills to document findings, prepare reports, and interact with regulatory inspectors.
Additional Skills & Qualifications
- Bachelor's degree in Biology, Chemistry, Toxicology, Animal Science, Life Sciences, or a related discipline.
- 25 years of experience specifically related to GLP in vitro studies, including genetic mouse toxicology.
- Prior experience working in another CRO environment, particularly with GLP-regulated studies.
- Exposure to ISO standards relevant to laboratory and medical device testing environments.
- Experience handling medical devices for testing, including preparing extractions from devices to be dosed to animals.
- Familiarity with determining device surface areas for extraction, including complex configurations such as tubing sets and associated components.
- Experience with cell culture techniques and working with fluorescent microscopes to read slides and interpret assay results.
- Ability to support continuous improvement initiatives within quality systems and compliance programs.
- Interest in contributing to research focused on curing cancer and improving patient outcomes.
- Capability to learn new procedures and systems quickly, supporting efficient onboarding and cross-training in laboratory operations.
Work Environment
This role is based in a contract research organization environment that conducts nonclinical animal studies, including toxicology and biocompatibility testing. The auditor works closely with laboratory operations, toxicology, chemistry, and animal facilities, reviewing studies that involve GLP in vitro assays, genetic mouse toxicology, and medical device testing. The work involves regular interaction with scientists, study directors, and quality assurance teams, as well as preparation for client and regulatory inspections. The environment emphasizes rigorous documentation practices, data integrity, and adherence to FDA and EPA GLP regulations. Work is performed in laboratory and office settings, with exposure to animal research activities and medical device testing workflows. The culture values scientific excellence, compliance, and a mission-driven focus on advancing research to help cure cancer, and supports training and development to enable team members to contribute effectively to new projects.
Job Type & Location
This is a Contract position based out of DAYTON, NJ.
Pay and Benefits
The pay range for this position is $40.00 - $50.00/hr. Individual compensation offered for this position within this range will depend on many factors, including qualifications, skills, relevant experience, job knowledge, geographic location, internal equity, and other pertinent job-related factors. Eligibility requirements apply to some benefits and may depend on your job
classification and length of employment. Benefits are subject to change and may be
subject to specific elections, plan, or program terms. If eligible, the benefits
available for this temporary role may include the following:

Medical, dental & vision
Critical Illness, Accident, and Hospital
401(k) Retirement Plan Pre-tax and Roth post-tax contributions available
Life Insurance (Voluntary Life & AD&D for the employee and dependents)
Short and long-term disability
Health Spending Account (HSA)
Transportation benefits
Employee Assistance Program
Time Off/Leave (PTO, Vacation or Sick Leave)
Workplace Type
This is a fully onsite position in DAYTON,NJ.
Application Deadline
This position is anticipated to close on Oct 22, 2026. About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 20,000 consultants and 5,000 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. We are proud to be an Engineering News-Record (ENR) Top 500 Design Firm for our engineering design services and a ClearlyRated Best of Staffing® winner for both client and talent service.

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Pursuant to the San Francisco Fair Chance Ordinance, for all positions located in the
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