New

Quality Assurance Auditor I

Inotiv
parental leave, paid time off, 401(k)
United States, Indiana, West Lafayette
2701 Kent Avenue (Show on map)
Feb 04, 2026
The QA Auditor is responsible for ensuring the highest standards of regulatory compliance and data integrity within the facility. This role involves performing rigorous audits of laboratory processes, study data, and facility records, while managing the reporting lifecycle from initial findings to the issuance of final Quality Assurance Statements. The Auditor serves as a subject matter expert on GLP standards, electronic audit trails, and master schedule maintenance, supporting both internal operations and external regulatory inspections. Corporate Demonstrate Inotiv Core Values Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures Maintain confidential information General Interact with clients, other employees, and the community in a professional manner Support and participate in company initiatives as directed Maintain thorough knowledge of facility SOPs, policies, study protocols, etc. Adhere to all safety regulations and procedures Provide assistance or support to other Inotiv QA team members as necessary Perform other duties as assigned Specific Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods and relevant regulations (audits may include direct observation of study conduct and/or laboratory processes, review of protocols, study data and reports, or review of facility records and SOPs as well as subcontractor contributions) Prepare an audit report and submit all findings to Study Director/Principal Investigator and management promptly Issue accurate quality assurance statements for inclusion in final reports. Become familiar with electronic data collection systems used in data generation, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, and QC. Input and/or update information in the Master Schedule program as required by GLP regulations and SOPs Participate in process or facility inspections, as assigned Assist with audits and inspections conducted by Sponsors and regulatory agencies as requested Support training of other employees and provide guidance on regulatory topics as requested Perform other duties as assigned. This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level. Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world. Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!* Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.