Quality Assurance Auditor

4 weeks ago


Gaithersburg, Maryland, United States Inotiv Full time
Job Title: Quality Assurance Auditor

Job Summary:

Inotiv is seeking a Quality Assurance Auditor to join our team at our Gaithersburg, MD facility. As a Quality Assurance Auditor, you will be responsible for ensuring compliance with Good Laboratory Practices (GLPs) and Standard Operating Procedures (SOPs).

Responsibilities:

- Perform protocol, critical phase, raw data, and report audits for compliance with GLPs, SOPs, and protocol.
- Report all findings from the audits and inspections to Study Directors, Principal Investigators, Test Site Management, Test Facility Management, and Operational Management.
- Inspect in-life phases and facilities as required for compliance with GLPs and SOPs.
- Maintain properly indexed quality assurance records, including study-specific files, inspection/audit status reports, protocols, and amendments.
- Participate in or conduct subcontractor, vendor, and internal facility inspections for compliance with GLPs and SOPs.
- Become familiar with electronic data collection systems used in data generation.
- May participate in quality assurance inspections from existing or potential clients and regulatory agencies.

Requirements:

- BS/BA in biological sciences or related field with 2 years of GLP auditing experience.
- Excellent written and verbal communication skills.
- Excellent time management skills.

About Inotiv:

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. We are committed to delivering world-class drug discovery and development solutions that impact the health and well-being of people all over the world.

Benefits:

- 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.

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