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 activities.
• Assist with trend analysis of quality events and audit findings.
• Support equipment qualification and method validation reviews.
• Conduct in-process audits and facility housekeeping audits.
• Contribute to quality metrics, dashboards, and management review activities.
• Recommend and implement continuous improvement initiatives.

Professional Development

• Complete required training and maintain qualification status.
• Stay current on applicable regulations, standards, and quality practices.
• Follow all company policies, procedures, and safety requirements.

Qualifications

Education

• Associate degree in a scientific discipline with relevant laboratory experience; or
• Bachelor's degree in Biology, Microbiology, Chemistry, Life Sciences, or a related scientific field preferred.

Experience

Quality Auditor I

• 0-2 years of quality, laboratory, compliance, or related experience.
• Basic understanding of quality systems and regulated environments.
• Demonstrated attention to detail and organizational skills.

Quality Auditor II

• 2+ years of laboratory, quality assurance, or auditing experience in a regulated environment.
• Experience conducting investigations, CAPAs, document reviews, and quality system activities.
• Ability to independently interpret regulations and make quality-related decisions.
• Demonstrated success supporting process improvement initiatives.

Knowledge, Skills & Abilities

Successful candidates will demonstrate:

• Strong attention to detail and accuracy
• Excellent written and verbal communication skills
• Analytical thinking and problem-solving abilities
• Ability to work independently and collaboratively
• Strong organizational and time-management skills
• Ability to manage multiple priorities in a fast-paced environment
• Effective interpersonal and customer service skills
• Proficiency with Microsoft Office and quality management systems
• Ability to interpret regulatory requirements and quality standards
• Initiative, accountability, and sound judgment

Additional qualifications for Quality Auditor II include:

• Experience leading investigations and CAPA activities
• Ability to provide regulatory and procedural guidance to stakeholders
• Experience presenting quality metrics, trends, and recommendations to leadership
• Demonstrated mentoring, training, or subject matter expertise within quality functions.

Sotera Health goes to market through its three best-in-class businesses - Sterigenics, Nordion and Nelson Labs. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries.