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 II 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.

Essential job functions:

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.

Education and experience requirements:

A.A. / A.S. and three years applicable NLI laboratory experience OR B.S. (Microbiology or biological science degree strongly preferred or NLI equivalent)

Two years NLI applicable laboratory or quality experience in addition to demonstrated proficiency for attention to quality.

Master trainer in job description functions.

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

Physical requirements: Must be able to stand and walk in the lab 60% of the day and sit and type at a computer for 40% percent of the day. Lifting is minimal.

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.