GLP Auditor

Overview:

A well-known National company is looking to hire a GLP Auditor to support operations in Santa Clara, CA. Ideal candidates will have knowledge of working in GLP, working with study protocols, and in vivo products. This is a fully onsite position with the possibility of some travel

Duties:

• 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).
• 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.
• Inspecting each nonclinical laboratory study to assure integrity and maintain written and properly signed records of each periodic inspection showing the date and the study inspected, the phase or segment of the study inspected, the person performing the inspection, findings and problems, action recommended and taken to resolve existing problems, and any scheduled date for re-inspection.
• Periodically submit to management and the study director written status reports on studies, noting any problems and the corrective actions taken.
• 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.
• Ensuring that appropriate quality auditing programs & related documentation is established & maintained in the area.

Additional Skills & Qualifications:

• Individual should have hands-on GLP Auditing experience: Certified Auditor is a plus,
• Performed audits to GLP (21 CRF Part 58)
• 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 with experience in the area of laboratory animal sciences or related subjects with some level of training & experience related to GLP, FDA (Food & Drug Administration) & USDA (United States Department of Agriculture) processes.

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