Quality Assurance Auditor III

About the role

This role involves demonstrating Inotiv's core values while adhering to standard operating procedures and company policies. Responsibilities include maintaining confidentiality, interacting professionally with clients and colleagues, supporting company initiatives, and performing various tasks such as audits, preparing audit reports, and participating in training sessions.

Responsibilities

• Maintain confidentiality and professional interactions with clients, employees, and the community
• Adhere to safety regulations and procedures
• Support and participate in company initiatives as directed
• Perform audits of studies and facilities to assess compliance with protocols, SOPs, methods, and relevant regulations
• Prepare and submit audit reports and quality assurance statements
• Manage quality programs to ensure compliance with regulatory requirements
• Support and participate in quality assurance inspections from clients and regulatory agencies
• Conduct site-specific and corporate quality training for new hires and employees
• Champion the development of standard quality policies, procedures, job aids, and training documents
• Investigate and implement corrective and preventive actions for quality issues and risks
• Apply problem-solving methodologies including root cause analysis
• Participate in or lead subcontractor and vendor evaluations
• Engage in equipment and software validation efforts
• Represent the QA team on regulatory topics
• Participate in departmental projects as assigned

Requirements

• Bachelor’s degree or higher in chemistry or life sciences, or equivalent combination of education and experience
• Three to five years of experience in a GLP setting, with one to three years of auditing experience preferred
• RQAP-GLP certification preferred

Qualifications

• Strong understanding of FDA and EPA GLPs and applicable international regulations
• Able to keep up-to-date with new rules, guidance, and industry standards
• Knowledge of electronic data collection systems and their proper use, reporting, audit trails, security, and Part 11 compliance
• Ability to input and update information in the Master Schedule program according to GLP regulations and SOPs
• Experience with quality assurance and compliance

Skills

• Excellent communication and interpersonal skills
• Strong analytical and problem-solving abilities
• Attention to detail and ability to manage multiple tasks
• Proficiency in Microsoft Office applications

Benefits

Inotiv offers competitive compensation, comprehensive benefits, and a supportive work environment. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Pay

The salary range for this role will be determined based on experience and qualifications, with a competitive starting point.

Schedule

The schedule for this role will be flexible to accommodate the needs of the employee and the company.