Quality Auditor (Day Shift)

Sotera Health-posted 2 months ago
Taylorsville, UT
1,001-5,000 employees
Miscellaneous Manufacturing
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The Quality Auditor reviews GLP studies for completeness, compliance, concurrence, and accuracy. The auditor provides regulatory and policy and procedural guidance to the lab staff. Additionally, the auditor collaborates with lab personnel in design, implementation, and performance of testing with the goal of improving and building quality into the process.

  • Review each GLP study prior to release for testing.
  • Audit a portion of each GLP study to ensure compliance with regulations, standards, and procedures.
  • Assist quality staff and lab staff in quality trend analysis.
  • Perform internal process audits.
  • Know and follow GLP, GMP and relevant ISO regulations.
  • Review and trend quality events (deviations and non-conformances, CAPA).
  • Review out of range events.
  • Review discontinued studies.
  • Review and trend amended reports.
  • Review duplicate reports.
  • CAPA: Initiation, investigation, resolution, and verification.
  • Review standard procedure documents in Master Control (collaboration and approval).
  • Review logbooks.
  • Meet regularly with Section Leader, Study Directors and Lab Analysts.
  • Prepare Dashboard and Quarterly Management Review with Section Leader.
  • Audit and review in-process testing and data.
  • Assist QA Regulatory with internal audits.
  • Review validation protocols, raw data, and reports.
  • Associate's degree and 2 years of relevant experience.
  • Bachelor's Degree (Relevant Life Science preferred, Microbiology, Biology, etc.).
  • 4+ years of directly relevant Quality Assurance background.
  • Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts.
  • 401(k) program with Company match that immediately vests.
  • Paid holidays, vacation and sick time.
  • Free financial planning assistance.
  • Paid parental leave.
  • Education assistance.
  • Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance.
  • Employee Assistance Program (EAP).
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