Quality Auditor I or II

About the role

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.

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.
  • 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

• Quality Auditor I:
  • 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.
  • 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

• 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:
  • Experience leading investigations and CAPA activities.
  • Experience providing 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.