Quality Assurance Auditor III

Corporate

• Demonstrate Inotiv Core Values

• Follow all Standard Operating Procedures (SOPs) and other applicable laboratory or company policies and procedures

• Maintain confidential information

General

• 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

Specific

• 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.

Education and Experience

• B.S. in chemistry or life sciences or Bachelor's degree or higher in a related field and

• Three to five years of experience in a GLP preferably with 1-3 or more years of auditing experience, or

• Equivalent combination of education and regulatory, quality, compliance and/or industry experience.

• RQAP-GLP certification preferred.

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.