Quality Auditor I

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.

Job Summary:

The Quality Auditor I reviews GLP studies for completeness, compliance, concurrence, and accuracy. The auditor provides regulatory and policy and procedural guidance. The auditor collaborates with lab personnel in design, implementation, and performance of testing with the goal of improving and building quality into the process. The auditor demonstrates proficient knowledge of quality practices and can perform job functions extending throughout the auditor’s quality audit team. Additionally, the auditor demonstrates proficiency in independent decision-making in regards to the interpretation of standards and regulations, performance of investigations, and other quality practices. The auditor has a history of successful process improvement implementation.

Key Responsibilities:

GLP Studies

• Review each GLP study prior to release for testing.

• Audit a portion of each GLP study.

• Review each GLP study and final report prior to mailing.

Regulatory and Policy & Procedural Guidance

• Know and follow GLP, GMP and relevant ISO regulations

• Perform quality event investigations and approvals

• Trend quality events

• Review and approve protocol detail sheets

• Review out of range forms

• Review discontinued studies

• Review and trend amended reports

• Review duplicate reports

• CAPA: Initiation, investigation, resolution, and verification

• Review documents in Master Control (collaboration and approval)

• Review logbooks

Process Improvement

• Meet regularly with Section Leader, Study Directors and Lab Analysts

• Prepare Dashboard and Quarterly Management Review with Section Leader

• Audit studies in-process

• Assist Regulatory Affairs with internal audits

• Review and approve equipment qualifications and test method validations

• Perform good housekeeping (GHP) audits

• Perform other duties as assigned.

Professional Development

• Complete required training on time (includes MasterControl, live company trainings, New Employee Orientation, etc.)

• Know and follow company policies and procedures.

Job requirements:

• Attention to detail

• Proficient verbal & written communication skills

• Ability to work independently

• Independent/ collaborative decision making/problem solving

• Time management- response time, meeting deadlines

• Excellent customer service/interpersonal skills

• Ability to multi-task

• Self-motivated/initiative

• Conflict management

• Follow instructions/assist others

• Presentation skills/public speaking for dashboards

• Project presentation

• Basic Algebra/ math skills

• Basic computer skills

• Dependable

Education and experience requirements:

• At least 2 years of quality experience, with an associate degree preferred.

• Or 4 years of quality experience without the degree.

Physical Requirements:

Must be able to sit for extended periods of time, must be able to be on the phone with clients and internal staff for extended periods of time.

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.