Inotiv
Healthcare
QualityAssuranceAuditorIII
“Quality Assurance Auditor III at Inotiv. Skills: GLPs, auditing, regulatory compliance, quality assurance. 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”
What You'll Achieve.
ensure compliance with protocols, SOPs, methods and relevant regulations; ensure elimination or mitigation of quality issues and risks
Industry & Context.
Apply problem solving methodology including root cause analysis to situations where data suggest process is not operating effectively or variability exceeds expectations
What They're Looking For.
Must Have
B. S. in chemistry or life sciences or Bachelor’s degree or higher in a related field, Three to five years of experience in a GLP, 1-3 or more years of auditing experience, Equivalent combination of education and regulatory, quality, compliance and/or industry experience
Nice to Have
RQAP-GLP certification
What You'll Do.
Conduct audits of designated studies and facilities to assess compliance with protocols
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
Input and/or update information in the Master Schedule program as required by GLP regulations and SOPs
Support investigation and CAPA activities to ensure elimination or mitigation of quality issues and risks
Participate in or lead subcontractor and/or vendor evaluations
Participate in equipment and software validation efforts
Perform other duties as assigned
How You'll Work.
Team & Collaboration
Interact with clients, other employees, and the community in a professional manner; Provide assistance or support to other Inotiv QA team members as necessary; Actively participate in managing quality program to ensure compliance with regulatory requirements and serve as a resource for staff on regulatory topics; Support and/or participate in quality assurance inspections from existing or potential clients and regulatory agencies; Assist with managing responses including provision of corrective and preventive actions as assigned; Serve as a resource to represent the QA team on regulatory topics (e. g, at study initiation meetings), as requested; Participate in departmental business, process or general regulatory projects, as assigned
Communication Scope
Interact with clients, other employees, and the community in a professional manner; 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; Serve as a resource to represent the QA team on regulatory topics
Process & Methodology
Participate in or lead subcontractor and/or vendor evaluations, Participate in equipment and software validation efforts
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