Quality Assurance Auditor
Mount Vernon, IN
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.
The Quality Assurance Auditor independently audits, and reviews regulated studies under the direction of a senior Quality Assurance staff member. The Quality Assurance Auditor will verify adherence to standard operating procedures (SOPs), protocols, and applicable government regulations and report findings to Management and other appropriate parties as defined by applicable government regulations and company policy.
- Conducts audits of designated studies and facilities to assess compliance with protocols, SOPs, and relevant national 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 standard operating procedures
- Prepares an audit report after each audit or review and recommends corrective actions to deficiencies as needed
- Assist with audits and inspections conducted by sponsors and regulatory agencies as related to auditing activities
- Provides staff guidance on SOP and documentation requirements
- Maintain QA files
- Keep abreast of new rules, guidance and industry standards in order to improve laboratory compliance
- Review data for proper documentation, adherence to the written methods and procedures, and accurate calculations
- Review of reports and data tables
- Conduct study based, process and facility audits
- Train other employees as requested
- Provide guidance on documentation requirements as requested
B.S. in chemistry, or B.S./B.A. in related field with 1-3 years pharmaceutical auditing experience, or 3-5 years of pharmaceutical laboratory experience with 1 year of auditing experience or an equivalent combination of education and experience.
*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 has been named a 2023 Top Workplace!
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 participation with company match, 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, gender, gender identity, sexual orientation, 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.