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.

　　Provide Compliance Oversight and training to internal personnel.

　　Perform internal GLP activities to conform with the GLP regulations (21 CFR Part 58)

　　Maintaining a copy of a master schedule sheet of all nonclinical laboratory studies conducted at the site that is indexed by test article and containing the test system, nature of study, date study was initiated, current status of each study, identity of the sponsor, and name of the study director.

　　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.

　　Additional Skills & Qualifications:

　　Minimum Bachelors Degree

　　GLP experience

　　Preferred auditing experience

　　Cytotoxicity lab experience preferred

　　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 [email protected] (%[email protected]) for other accommodation options.