Quality Auditor I

Responsibilities

• Review GLP studies for completeness, compliance, concurrence, and accuracy prior to testing and release.
• Audit portions of GLP studies and final reports to ensure regulatory alignment.
• Provide guidance on GLP, GMP, and relevant ISO regulations.
• Perform quality event investigations, trending, and CAPA (initiation, investigation, resolution, and verification).
• Review and approve 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.

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.
• Strong problem-solving and collaborative decision-making abilities.
• Basic algebra, math, and computer skills.
• Excellent time management and the ability to meet deadlines while multi-tasking.
• 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 lab testing and sterilization solutions to ensure the safety of patients and healthcare practitioners worldwide.