Quality Auditor (Day Shift)Sotera Health • Salt Lake City, UT, United States
Quality Auditor (Day Shift)
Sotera Health • Salt Lake City, UT, United States
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job_description.job_card.job_descriptionReview each GLP study prior to release for testing. Audit a portion of each GLP study to ensure compliance with regulations, standards, and procedures. Review each GLP study and final report prior to mailing. 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 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)
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.
Education and experience requirements :
- Associate's degree and 2 years of relevant experience OR
- Bachelor's Degree (Relevant Life Science preferred, Microbiology, Biology, OR
- 4+ years of directly relevant Quality Assurance background
Essential job functions :
GLP Studies
Regulatory and Policy & Procedural Guidance
Process Improvement
Nelson offers a competitive benefits package that includes :
Physical requirements :
Must be able to stand / walk for 10% of the day and 90% of the day sitting at a desk or on the computer. Must be able to occasionally lift a maximum of 45lbs.
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Quality Auditor • Salt Lake City, UT, United States
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