Quality Auditor I or II

Nelson Laboratories, LLC; Taylorsville (UT); Sur place; USD 60 000 - 90 000; Plein temps

Résumé du poste

Sotera Health is seeking a Quality Auditor II to ensure GLP study integrity and regulatory compliance across multiple facilities. The role partners with lab professionals to design, implement and improve testing quality, and to support investigations and CAPAs with independent decision making.

The successful candidate will demonstrate strong attention to detail, clear communication, and the ability to manage multiple audits and dashboards while upholding corporate policies and timelines.

Qualifications

• Attention to detail and accuracy in GLP studies.
• Strong verbal and written communication skills for cross-functional teams.
• Ability to work independently and make informed decisions.
• Effective time management and prioritization to meet deadlines.
• Customer service and interpersonal skills for regulatory interactions.
• Proficiency with dashboards and data presentation.

Responsabilités

• Review GLP studies prior to release for testing.
• Audit portions of GLP studies and final reports.
• Provide regulatory guidance and ensure compliance with GLP, GMP and ISO.
• Assist in CAPA investigations and verifications.
• Contribute to process improvements and master control documentation.
• Prepare and present dashboards for quarterly reviews.
• Participate in internal audits and cross-functional reviews.

Connaissances

Attention to detail

Verbal & written communication

Independent decision making

Time management

Customer service

Multi-tasking

Self-motivated

Presentation skills

Formation

A.A./A.S. in a scientific field

B.S. in Microbiology or biological sciences

Outils

MasterControl

Description du poste

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.

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.

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) and two years NLI applicable laboratory or quality experience in addition to demonstrated proficiency for attention to quality. Master trainer in job description 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.