|Date Posted||May 8, 2018|
Kelly Services is currently seeking a Quality Auditor for one of our top clients in Cincinnati, OH.
- This job description covers the skills responsibilities for the QAU Quality Assurance Unit / GLP Good Laboratory Practice Auditor position.
- 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 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
EDUCATION / DEGREE REQUIRED:
- 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.
- Or- Associate degree with experience in the area of laboratory animal sciences or related subjects certification as a Laboratory Animal Technologist or Registered Veterinary Technician with training experience related to GLP, FDA USDA processes. Associate de
Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. Applicants must be legally permitted to work in the United States.
- As a Kelly Services employee, you will have access to numerous perks, including:
- Exposure to a variety of career opportunities as a result of our expansive network of client companies
- Career guides, information and tools to help you successfully position yourself throughout every stage of your career
- Access to more than 3,000 online training courses through our Kelly Learning Center
- Weekly pay and service bonus plans
- Group-rate insurance options available immediately upon hire*
*Available for purchase and administered by a designated third-party vendor
Kelly puts you in charge of your career, with access to cutting edge projects and technologies in
industry leading organizations. Top companies throughout the world have trusted Kelly as a premier
source of engineering talent and services since 1965. And engineering job seekers know Kelly as a firm
with an unmatched reputation for quality, integrity and professionalism. Whether you seek the variety
and flexibility of working on short term project engagements, or prefer contract-to-hire or direct
hire placement with our clients, apply with Kelly to explore opportunities that suit your specific
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Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and is
committed to employing a diverse workforce. Equal Employment Opportunity
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