Quality Assurance Auditor III

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 

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.