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 J&J 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 internal GLP activities to conform with the GLP regulations (21 CFR 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.
Numerous administrative responsibilities & requires the ability to coordinate personnel for audit activities, educate & train associates in GLP practices.
We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.
The company is an equal opportunity employer and will consider all applications without regards 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 call 888-237-6835 or email accommodation@aerotek .com for other accommodation options. However, if you have questions about this position, please contact the Recruiter located at the bottom of the job posting. The Recruiter is the sole point of contact for questions about this position.
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