What are the responsibilities and job description for the Quality Auditor (Swing Shift) position at Nelson Labs?
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.
Required
Education and experience:
GLP Studies
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. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. 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.
Required
Education and experience:
- 2 years of Quality Audit experience; reviewing Audits/Reports for accuracy
- Experience with Regulatory Standards and applying the appropriate logic to Quality Reviews
- Bachelors Degree in a relevant Life Science; Biology, Microbiology, Chemistry or similar
- Experience Providing QA support in a Scientific Environment, or a Medical/Pharma testing facility specifically, very highly desired
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.
- 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
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. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. 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.
