Description:

　　This individual will be doing on-site audits of the lab, helping business partners with Good Documentation Practices, answering questions, etc.

　　Responsibilities:

　　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.

　　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.

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

　　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

　　Actalent is an equal opportunity employer.

　　About Actalent

　　Actalent connects passion with purpose. We help visionary companies advance their engineering and science initiatives through access to specialized experts that drive scale, innovation, and speed to market. With a network of almost 30,000 engineering and sciences consultants and more than 4,500 clients across the U.S., Canada, Asia, and Europe, Actalent serves many of the Fortune 500. An operating company of Allegis Group, the global leader in talent solutions, Actalent launched as a new specialized engineering and sciences services and workforce solutions brand in 2021.