Quality Assurance Auditor I

4 days ago


Rockville, Maryland, United States Inotiv Full time
Pharmaceutical Quality Expert Job Description

Inotiv, a leading contemporary drug discovery and development company, is seeking a highly skilled Pharmaceutical Quality Expert to join our team. As a key member of our quality assurance team, you will play a critical role in ensuring the highest standards of quality and compliance in our operations.

About Inotiv

We are a dynamic and growing organization that values innovation, teamwork, and excellence. Our mission is to deliver world-class drug discovery and development solutions that impact the health and well-being of people around the globe. We believe in empowering our employees to make a meaningful difference in their careers and beyond.

Job Summary

The successful candidate will be responsible for conducting audits of designated studies and facilities to assess compliance with protocols, SOPs, methods, and relevant regulations. You will also prepare audit reports, issue quality assurance statements, and participate in process or facility inspections as assigned.

Responsibilities:
  • Conduct audits of designated studies and facilities to assess compliance with protocols, SOPs, methods, and relevant regulations.
  • Prepare audit reports and submit findings to Study Director/Principal Investigator and management promptly.
  • Issue accurate quality assurance statements for inclusion in final reports.
  • Participate in process or facility inspections as assigned.
Requirements:
  • Bachelor's degree in chemistry or life sciences or related field.
  • 1-3 years of pharmaceutical auditing experience or 3-5 years of pharmaceutical laboratory experience with 1 year of auditing experience.
  • Equivalent combination of education and regulatory, quality, compliance, and/or industry experience.
  • Excellent written and verbal communication skills.
  • Good organizational skills and attention to detail.
Salary and Benefits

The estimated salary for this role is $63,400-$75,500 per year, based on location and level of experience. In addition to a competitive salary, we offer a comprehensive benefits package, including health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401(k), and more.

About Inotiv Culture

Inotiv is an equal opportunity employer that values diversity, equity, and inclusion. We strive to create a work environment that is inclusive and respectful of all employees, regardless of age, race, color, religion, sex, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law.



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