Quality Assurance Auditor

Inotiv is looking to hire a Quality Assurance Auditor at our Gaitherburg, MD facility. 

Pay Range: $60,600-$84,800. All job offers will be based on a candidate’s skills and prior relevant experience, applicable degrees/certifications, as well as internal equity and market data. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Corporate Responsibilities:

• Adherence to laboratory health and safety procedures.
• Adherence to Standard Operating Procedures (SOPs).
• Adherence to applicable company policies and guidelines.
• Adherence to federal and/or local regulations, as applicable.

Position 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 and scientific personnel.
• Inspect in-life phases and facilities as required for compliance with GLPs and SOPs and observe technical and professional staff for adherence to health and safety, SOP, and GLP standards.
• Maintain properly indexed quality assurance records, including study-specific files, inspection/audit status reports, protocols and amendments, internal facility inspection reports, audit logs, and other general QA records. Assure all QA records are up-to-date and accurate and compile the appropriate records for study-specific archiving.
• Input/update information into the Master Schedule program as required by GLP regulations.
• 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, including proper use, reporting, audit trails, security/Part 11 compliance, data correction, QC, etc.
• May participate in quality assurance inspections from existing or potential clients and regulatory agencies, e.g. FDA, EPA.
• May participate in equipment and software validation efforts.
• Attend pre-initiation, pre-planning, or operational team meetings.
• Issue quality assurance statements for inclusion in final reports.
• Maintain and coordinate the archiving of QA study files.
• Assist or perform other job duties as assigned.

Professional Responsibilities:

• Attend continuing education courses or webinars, as appropriate.
• Maintain membership in the Society of Quality Assurance.

• 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.

*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 for this role is $60,600- $84,800 and could 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.

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, 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.

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