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).
• Ensure site compliance to the J&J Policy on Animal Welfare
• 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) across the MedTech Community
• 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 at intervals adequate to assure the integrity of the study and maintain written and properly signed records of each periodic inspection showing the date of the inspection, 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. Any problems found during the course of an inspection which are likely to affect study integrity shall be brought to the attention of the study director and management immediately.
• 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.
• Ensuring that appropriate quality auditing programs & related documentation is established & maintained in the area.

Skills:

GLP, cGLP, 21 CFR Part 58, AAALAC, medical device, computer validation

Additional Skills & Qualifications:

Individual should have hands-on GLP Auditing experience. Not just assisting. A certified auditor would be 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.

Experience Level:

Intermediate Level