Quality Assurance Auditor III

Inotiv•West Lafayette, IN

1d•Onsite

About The Position

This role is for a Quality Assurance Auditor III at Inotiv, a drug discovery and development company. The auditor will be responsible for ensuring compliance with FDA and EPA GLPs, as well as applicable international regulations. This involves conducting audits of studies and facilities, preparing audit reports, and providing quality assurance statements. The position also involves inputting information into the Master Schedule program, participating in quality program management, supporting client and regulatory agency inspections, and conducting quality training. The role champions the development of quality policies and procedures, supports investigation and CAPA activities, and applies problem-solving methodologies. The auditor will also participate in subcontractor/vendor evaluations and equipment/software validation efforts, and serve as a resource for regulatory topics.

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 preferably with 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.