Location: Cincinnati, Ohio, USA
Salary: US$50 - US$65 per hour + Benefits, 401k
Job Type: Contract
The QAU / GLP Auditor is responsible for:
- 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.
- Assessing sites for compliance to the Policy on Animal Welfare
- 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 internalGLP activities to conform with theGLP regulations (21CFR Part 58) across the Medical Device Community:
- Maintaining a copy of a master schedule sheet of all nonclinical laboratory studies conducted at Ethicon 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.
- Daily support of the Analytical Chemistry / Material Characterization GLP Program.
- Ensuring that appropriate quality auditing programs & related documentation is established & maintained in the area.
Sthree US is acting as an Employment Business in relation to this vacancy.