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Posted: Saturday, August 19, 2017 9:45 PM

Company OverviewFor more than 55 years, SNBL (Shin Nippon Biomedical Laboratories, Ltd) has been a leader in helping biopharmaceutical companies generate high quality data with the exceptional precision needed to rapidly advance new medical therapies and innovations that improve patientsA? lives, SNBL has facilities in Japan, the United States, China, and Cambodia. Our international footprint enables us to meet the research needs of clients around the globe. We are committed to providing our customers with fast and precise results across the entire drug development spectrum, from early discovery research to late:stage clinical trials. The SNBL team is dedicated as a company and as individuals in working with our clients to improve patient care and treatment outcomes. This is a cornerstone in our drive for excellence across all aspects of our business. SNBL USA, Ltd. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to status as a protected veteran or a qualified individual with a disability, or other protected status. SummaryThe Quality Assurance group provides independent QA oversight to assure integrity of nonclinical laboratory studies. They work closely with management and organizational groups to identify improvement opportunities and educate staff in GLP regulatory requirements. They pride themselves on being GLP regulatory experts for the business. QA Computerized Systems Auditor: You will serve as the regulatory expert to assure management that computerized systems are implemented, operated and maintained in accordance with company standard operating procedures and FDA GLP and Part 11 regulations.Conduct audits of equipment qualification and computerized system validation projectsPerform periodic audits of ongoing computerized system operation, maintenance and change managementParticipate in computerized system vendor evaluations to assess the suitability of vendorA?s quality management system and system development practicesPerform facility and system audits to ensure departmental compliance with the regulationsApply expertise to help solve compliance issues and meet company objectives by evaluating and identifying possible root causesPerform administrative responsibilities including managing audit reports and maintaining files to support audit activitiesConduct regulatory reviews of validation and qualification SOPsTrain staff by conducting training seminars and distributing information on GLP and Part 11 regulations and other related standardsSupport client visits and regulatory inspectionsTwo years of computerized systems validation:related experience within an FDA:regulated environmentFour years of FDA GLP QA experienceRelevant BachelorA?s degree (B.S.) or equivalent combination of education and experienceStrong working knowledge of 21 CFR Part 58 and 21 CFR Part 11 and comprehensive knowledge of Computer Software Validation is a muAbility to write routine reports and correspondenceAbility to speak effectively before clients, regulatory agency representatives and groups of employees within the organizationDemonstrated ability to train employees in FDA and OECD GLP regulations and requirementsMust have ability to work independently with limited oversight as well as work collaboratively in a team settingMust have ability to work collaboratively with internal customers to pursue resolution of issues affecting data integrity and regulatory complianceTo be successful you must see beyond situational details, understand larger implications of non:compliances, and effectively communicate concerns to internal staff and managementCompetency in MS OfficeSome domestic travel may be required

Source: https://www.tiptopjob.com/jobs/71038445_job.asp?source=backpage


• Location: Everett

• Post ID: 53755268 everett
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