Quality Auditor I or 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.

About the Role

We are seeking a detail-oriented and quality-focused professional to join our team as a Quality Auditor I or Quality Auditor II.

This position plays a critical role in ensuring compliance with Good Laboratory Practices (GLP), Good Manufacturing Practices (GMP), applicable ISO standards, company policies, and regulatory requirements.

The Quality Auditor partners closely with laboratory personnel, Study Directors, Section Leaders, and Regulatory Affairs to review studies, support investigations, identify opportunities for process improvement, and help build quality into every aspect of laboratory operations.

Candidates may be hired as a Quality Auditor I or Quality Auditor II depending on qualifications, experience, and demonstrated expertise.

Quality Auditor II candidates are expected to operate with greater independence, provide regulatory guidance, lead investigations, and contribute to continuous improvement initiatives.

Key Responsibilities

GLP Study Auditing



* Review GLP studies for completeness, accuracy, compliance, and concurrence.


* Audit studies throughout various stages of testing.


* Review final reports prior to release and distribution.


* Ensure documentation meets regulatory and internal quality standards.


* Identify and communicate compliance concerns and audit findings.

Regulatory Compliance & Quality Systems



* Interpret and apply GLP, GMP, ISO, and company quality requirements.


* Conduct quality event investigations and support root cause analysis.


* Participate in CAPA activities, including initiation, investigation, implementation, and effectiveness verification.


* Review and approve quality documentation, protocol detail sheets, and controlled documents.


* Review out-of-specification or out-of-range events and other quality records.


* Support maintenance of quality systems and documentation controls.

Process Improvement & Operational Support



* Partner with laboratory teams to improve quality processes and compliance.


* Participate in internal audits and regulatory inspection readiness...