Quality Assurance Technician

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

• Performs the batch review and approval.
• Performs density studies on customer products and complete applicable tote loading diagrams.
• Assists the QA Manager in calibration of instruments used in safety and dosimetry systems and performance of quality control procedures.
• Assists the QA Manager in scheduled quality audits and “as needed” customer product inspections.
• Provides backup support for the QA Manager in a variety of functions.
• Reviews and release of production run in MIS system.
• Maintains Customer Master Files & Training records.
• Conducts Housekeeping audits in accordance with written procedures.
• Assists with other tasks assigned by Supervisor.

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.

Salary Range

• $47,000 – $75,000 per year

Training Required

• Must complete all required training for a “Quality Assurance Technician” outlined in the training manual.

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 8 of the top 10 global pharmaceutical companies. 

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. Learn more about Sotera Health at soterahealth.com. 

Sterigenics is a leading global provider of outsourced terminal sterilization services for the medical device, pharmaceutical, food safety and advanced applications markets. With our industry recognized expertise we help to ensure the safety of millions of patients around the world every year. Across our 48 global facilities, we offer our customers a complete range of sterilization services, primarily using the three major technologies: gamma irradiation, ethylene oxide processing and electron beam irradiation. We are committed to addressing the growing need for sterilization across the world and partnering with our customers to eliminate threats to human health. Learn more about Sterigenics at www.sterigenics.com 

Safeguarding Global Health® – with every product we sterilize.

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