Quality Assurance Technician

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.

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. Reporting to the Quality Assurance (QA) Manager, the Quality Assurance (QA) Technician is responsible for assisting the Plant QA Manager and Validation Coordinator (if applicable) in ensuring the quality system requirements are met and maintained.

This role assists in providing management with information and data on all key aspects of the day-to-day operation, which is used by both plant and corporate management to determine if the quality system is adequate and operating as designed. This information and data is also used to provide guidance for corrective actions and continuous improvement.

The QA Technician must effectively interface with Customer Service, Sales, Operations, Engineering and other plant and corporate staff, as well as customers and regulatory personnel.

Responsibilities

• Quality, Regulatory, & Safety Provides information and data reflecting the status of the plant quality system.
• Assists with corrective action and process improvement activities and assists in appropriate re-training.
• Monitors the quality and integrity of information required for the sterilization process history record (batch record) Issues release of processed materials.

• Assists in all activities relevant for FDA, customer and regulatory audits.
• Assists with the monthly review of Total Quality Management Report Assists with audits to ensure FDA/ISO/GMP compliance and to provide basis for continuous improvement.
• Assists with Quarterly Environmental monitoring of employees.
• Executes equivalency and retrospective re-validation studies/reports.

• Assists the Validation Coordinator with validations and calibrations.
• Analyzes temperature and humidity probe data.
• Other QA/Validation duties as assigned.
• Maintains all quality related training programs.

Qualifications

• High School Diploma or GED.
• One (1) to 1.5 years of experience working in a sterilization environment preferred.
• Must be able to read, write and speak fluent English.
• Should be proficient using a computer and be able to analyze data in a database/spreadsheet.
• Must be willing to work established shifts.
• Must be able to lift a minimum of 50 pounds and perform repetitive bending and lifting motions over a period of time.

Special Requirements Must be medically approved for respirator use (EO) Must be able to tolerate exposure to high temperature and high humidity (120F and 60% RH for 20 minutes) (EO) Training Required Must complete all required training for a "Quality Assurance Technician" outlined in the training manual. Benefits and Pay Rate Pay Rate: $53,000 to $83,000 annually, based on experience.

• We strongly encourage those from underrepresented groups to apply.
• We strongly encourage those from underrepresented groups to apply.
• VEVRAA Federal Contractor 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.