Quality Auditor II

Responsibilities

• Review GLP studies for completeness, compliance, concurrence, and accuracy prior to release and mailing
• Provide regulatory, policy, and procedural guidance regarding GLP, GMP, and ISO regulations
• Perform quality event investigations, including initiation, investigation, resolution, and verification of CAPAs
• Trend quality events and review protocol detail sheets, out of range forms, and discontinued studies
• Collaborate with Section Leaders, Study Directors, and Lab Analysts to drive process improvements
• Assist Regulatory Affairs with internal audits and perform good housekeeping (GHP) audits
• Review and approve equipment qualifications and test method validations
• Prepare dashboards and quarterly management reviews

Requirements

• A.A./A.S. with 3 years of applicable NLI laboratory experience OR a B.S. in Microbiology, Biological Science, or an NLI equivalent
• 2 years of NLI applicable laboratory or quality experience
• Proficiency in GLP, GMP, and relevant ISO regulations
• Experience with CAPA and quality event investigations
• Strong attention to detail and ability to work independently
• Basic algebra and math skills
• Proficient verbal and written communication skills

Preferred Qualifications

• Experience using MasterControl for document collaboration and approval
• Experience in a master trainer capacity for job description functions

About the Company

Nelson Labs, part of Sotera Health, is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Driven by the mission of Safeguarding Global Health®, we provide mission-critical sterilization and lab testing services to ensure the safety of patients and healthcare practitioners worldwide.