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Quality Auditor Investigator

Job Field: Legal Jobs
Location: SALT LAKE CITY, UT
Job Type: Full Time
JOB SUMMARY:
Quality Auditor Investigator is needed for a Salt Lake employer. Duties: The quality investigator is responsible for coordinating and managing all aspects of quality event investigations, root cause analysis and action items for the quality assurance team. The investigator collaborates with the primary auditor and with individual sections/functions to help support and carry out all segments of the investigation, and implements any action item, when necessary, to ensure issues are resolved.The quality investigator primarily oversees and focuses on quality events which necessitate a more in-depth investigation, pose a greater risk and have additional actions items which require timely follow-up. The quality investigator will support the primary auditor to provide regulatory and procedural guidance and to help building quality into the process. The investigator team will trend quality issues, develop appropriate action plans to correct and/or prevent adverse events, and report all findings/strategies to the Quality Assurance Management Team. The quality investigator also performs the job functions of a quality auditor as needed. Essential job functions: Know and follow GLP, GMP and relevant ISO regulations Perform quality event investigations and approvals Trend quality issues Review out of range forms Review and trend amended reports CAPA: Investigation, resolution, and verification (as applicable) Review documents in Master Control (collaboration and approval) GLP Studies Process Improvement Meet regularly with Section Leaders, Study Directors and Lab Analysts Prepare Dashboard/Quality reports for QA Management Assist Regulatory Affairs with internal audits Participate on QA committees and QA team projects Qualifications: Position requires Science B.S. (Microbiology strongly preferred) with 2 - 4 years laboratory experience desired. This position requires successful completion of a drug test and criminal background check. Hours are Monday - Friday 8/9AM to 4/5PM Equal Opportunity Employer.

KEY REQUIREMENTS:
Bachelors
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