Inotiv · 9 hours ago
Quality Assurance Auditor I
West Lafayette, IN
Full-time
Onsite
New Grad, Entry LevelInotiv is a growing contemporary drug discovery and development company, and they are seeking a Quality Assurance Auditor I. This role is responsible for ensuring regulatory compliance and data integrity through rigorous audits of laboratory processes and facility records, while also managing the reporting lifecycle from initial findings to final Quality Assurance Statements.
BiopharmaLife ScienceMedical DevicePharmaceutical
Responsibilities
Demonstrate Inotiv Core Values
Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures
Maintain confidential information
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
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
Qualification
Required
Ensure the highest standards of regulatory compliance and data integrity within the facility
Perform rigorous audits of laboratory processes, study data, and facility records
Manage the reporting lifecycle from initial findings to the issuance of final Quality Assurance Statements
Serve as a subject matter expert on GLP standards, electronic audit trails, and master schedule maintenance
Interact with clients, other employees, and the community in a professional manner
Maintain thorough knowledge of facility SOPs, policies, study protocols, etc
Adhere to all safety regulations and procedures
Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods and relevant regulations
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
Benefits
Health and dental coverage
Short- and long-term disability
Paid time off
Paid parental leave
401K
And more!
Company
Inotiv
Inotiv provides biopharmaceutical analytical, reproductive toxicology, medical device testing, DMPK, consulting and pathological services.
Founded in 1974
1001-5000 employees
H1B Sponsorship
Inotiv has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2023 (2)
2022 (1)
Funding
Current Stage
Public CompanyTotal Funding
$27.64MKey Investors
Indiana Economic Development Corporation
2024-12-18Post Ipo Equity· $27.6M
2022-06-20Grant· $0.04M
1997-11-28IPO
Leadership Team
Greg Beattie
Chief Operating Officer
Recent News
2025-12-13
Company data provided by crunchbase