Quality Auditor I

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 trending, CAPA initiation, investigation, resolution, and verification
• Review and approve protocol detail sheets, out of range forms, discontinued studies, and amended reports
• 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

Requirements

• A.A. / A.S. with 3 years of applicable NLI laboratory experience OR a B.S. in Microbiology or biological science
• 2 years of NLI applicable laboratory or quality experience
• Strong knowledge of GLP, GMP, and relevant ISO regulations
• Proficient verbal and written communication skills
• Basic algebra, math, and computer skills
• Ability to work independently and manage time effectively to meet deadlines

Preferred Qualifications

• Experience with MasterControl or similar quality management software
• Background in microbiological or analytical chemistry testing

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 testing and sterilization solutions to ensure the safety of patients and healthcare practitioners worldwide.