Nelson Laboratories Holdings, LLC in
Quality Auditor (Day Shift)
Nelson Laboratories Holdings, LLC in, Salt Lake City, Utah, United States, 84193
Overview
Quality Auditor (Day Shift) (Finance) 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 Bachelor's Degree (Relevant Life Science preferred, Microbiology, Biology, etc.) 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
Benefits
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. The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies. Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about
Sotera Health
at soterahealth.com.
#J-18808-Ljbffr
Quality Auditor (Day Shift) (Finance) 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 Bachelor's Degree (Relevant Life Science preferred, Microbiology, Biology, etc.) 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
Benefits
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. The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health®. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies. Sotera Health goes to market through its three best-in-class businesses - Sterigenics®, Nordion® and Nelson Labs®. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about
Sotera Health
at soterahealth.com.
#J-18808-Ljbffr