Job Title: GLP Auditor

Description:

• Monitoring each GLP study to assure management that the facilities, equipment, personnel, methods, practices, records, and controls are in conformance with the GLP regulations (21 CFR Part 58).

• Assessing Vendors for GLP Compliance and monitoring studies performed at the vendors

• Providing audit reports for audits / assessments performed.

• Working across the Medical Device companies to provide Compliance Oversight and training to internal personnel on GLP Sponsor Responsibilities.

• Assisting as necessary with the internal GLP activities to conform with the GLP regulations (21 CFR Part 58)

• Maintaining copies of all protocols pertaining to all nonclinical laboratory studies for which the unit is responsible.

• Periodically submit to management and the study director written status reports on each study, noting any problems and the corrective actions taken.

• Determine that no deviations from approved protocols or standard operating procedures were made without proper authorization and documentation.

• Review the final study report to assure that such report accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the nonclinical laboratory study.

• Prepare and sign a statement to be included with the final study report which shall specify the dates inspections were made and findings reported to management and to the study director.

• Daily support of the data integrity and GLP quality assurance program for Preclinical.

• Daily support of the Analytical Chemistry / Material Characterization GLP Program.

• Ensuring that appropriate quality auditing programs & related documentation is established & maintained in the area.

• Numerous administrative responsibilities & requires the ability to coordinate personnel for audit activities, educate & train associates in GLP practices.

Additional Skills & Qualifications:

• Individual should have hands-on GxP Auditing experience.

• Performed audits to GLP (21 CRF Part 58) or GMP

• Familiar with Laboratory Animal Care & Use Practices, such as Animal Welfare Act.

• Experience with GLP Auditing (CROs, Study Audits, System Audits).

• Society of Quality Assurance Membership / participation / certification is preferred.

• BS or equivalent degree

Work Site

This is a hybrid position requiring some days on-site in Blue Ash, Ohio and some days remote.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

• Hiring diverse talent

• Maintaining an inclusive environment through persistent self-reflection

• Building a culture of care, engagement, and recognition with clear outcomes

• Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.