Sotera Health Company
Quality Auditor (Day Shift)
Sotera Health Company, Salt Lake City, Utah, United States, 84193
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, etc.)
OR
4+ years of directly relevant Quality Assurance background
Essential job functions: GLP Studies
Review 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.
Regulatory and Policy & Procedural Guidance
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
Process Improvement
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
Nelson offers a competitive benefits package that includes:
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)
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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Education and experience requirements:
Associate's degree and 2 years of relevant experience
OR
Bachelor's Degree (Relevant Life Science preferred, Microbiology, Biology, etc.)
OR
4+ years of directly relevant Quality Assurance background
Essential job functions: GLP Studies
Review 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.
Regulatory and Policy & Procedural Guidance
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
Process Improvement
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
Nelson offers a competitive benefits package that includes:
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)
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.
#J-18808-Ljbffr