Quality Auditor II

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 9 of the top 10 pharmaceutical companies.Job SummaryThe Quality Auditor II reviews GLP studies for completeness, compliance, concurrence, and accuracy. The auditor provides regulatory and policy and procedural guidance. The auditor collaborates with lab personnel in design, implementation, and performance of testing with the goal of improving andbuilding quality into the process. The auditor demonstrates proficient knowledge of quality practices and can perform job functions extending throughout the auditor’s quality audit team. Additionally, the auditor demonstrates proficiency in independent decision-making in regards to the interpretation of standards and regulations, performance of investigations, and other quality practices. The auditor has a history of successful process improvement implementation.Key ResponsibilitiesGLP StudiesReview each GLP study prior to release for testing.Audit a portion of each GLP study.Review each GLP study and final report prior to mailing.Regulatory and Policy & Procedural GuidanceKnow and follow GLP, GMP and relevant ISO regulationsPerform quality event investigations and approvalsTrend quality eventsReview and approve protocol detail sheetsReview out of range formsReview discontinued studiesReview and trend amended reportsReview duplicate reportsCAPA: Initiation, investigation, resolution, and verificationReview documents in Master Control (collaboration and approval)Review logbooksProcess ImprovementMeet regularly with Section Leader, Study Directors and Lab AnalystsPrepare Dashboard and Quarterly Management Review with Section LeaderAudit studies in-processAssist Regulatory Affairs with internal auditsReview and approve equipment qualifications and test method validationsPerform good housekeeping (GHP) auditsPerform other duties as assigned.Professional DevelopmentComplete required training on time (includes MasterControl, live company trainings, New Employee Orientation, etc.)Know and follow company policies and procedures.Job RequirementsAttention to detailProficient verbal & written communication skillsAbility to work independentlyIndependent/ collaborative decision making/problem solvingTime management- response time, meeting deadlinesExcellent customer service/interpersonal skillsAbility to multi-taskSelf-motivated/initiativeConflict managementFollow instructions/assist othersPresentation skills/public speaking for dashboardsProject presentationBasic Algebra/ math skillsBasic computer skillsDependableEducation And Experience RequirementsA.A. / A.S. and three years applicable NLI laboratory experience OR B.S. (Microbiology or biological science degree strongly preferred or NLI equivalent)Two years NLI applicable laboratory or quality experience in addition to demonstrated proficiency for attention to quality.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.