Quality Auditor I

Responsibilities

• Review GLP studies for completeness, compliance, concurrence, and accuracy prior to testing and release.
• Provide regulatory, policy, and procedural guidance regarding GLP, GMP, and relevant ISO regulations.
• Perform quality event investigations, trend quality events, and manage CAPA (initiation, investigation, resolution, and verification).
• Review and approve protocol detail sheets, out of range forms, discontinued studies, and amended reports.
• Collaborate with lab personnel to improve quality processes and assist Regulatory Affairs with internal audits.
• Review equipment qualifications, test method validations, and perform good housekeeping (GHP) audits.
• Prepare dashboards and quarterly management reviews in coordination with Section Leaders.

Requirements

• 2 years of quality experience with an associate degree, OR 4 years of quality experience without a degree.
• Strong attention to detail and ability to work independently.
• Proficient verbal and written communication skills, including presentation skills for dashboards.
• Strong problem-solving, time management, and multi-tasking abilities.
• Basic algebra/math skills and basic computer proficiency.
• Ability to sit for extended periods and communicate via phone with clients and internal staff.

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 millions of patients and healthcare practitioners worldwide.