Quality Assurance Auditor III

Inotiv•West Lafayette, IN

About The Position

This role is for a Quality Assurance Auditor III at Inotiv, a drug discovery and development company. The position involves ensuring compliance with FDA and EPA Good Laboratory Practices (GLP), as well as other applicable regulations and company policies. The auditor will conduct various types of audits, prepare reports, and contribute to the overall quality management program. The company emphasizes a "Play to Win" culture and aims to deliver world-class drug discovery and development solutions.

Requirements

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 Haves

RQAP-GLP certification preferred

Responsibilities

Demonstrate solid understanding of application and interpretation of FDA and EPA GLPs as well as applicable international regulations
Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance
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
Demonstrate solid knowledge of 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
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
Conduct site-specific and corporate quality training for new hires and other employees, as assigned
Champion the development of standard Quality policies, procedures, job aids and training documents
Support investigation and CAPA activities to ensure elimination or mitigation of quality issues and risks
Apply problem-solving methodology including root cause analysis to situations where data suggest process is not operating effectively or variability exceeds expectations
Participate in or lead subcontractor and/or vendor evaluations
Participate in equipment and software validation efforts
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
Perform other duties as assigned
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