What are the responsibilities and job description for the Quality Assurance Technician position at Sotera Health Services, LLC?
Job Description
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
Special Requirements
Training Required
Pay & Benefits
Salary Range : $50,500 - $79,000 per year; depending on experience.
Sotera Health offers a competitive benefits package that includes :
All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, age, disability, or protected veteran status. Sterigenics U.S. LLC takes affirmative action in support of its policy to employ and advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities. We strongly encourage those from underrepresented groups to apply.
VEVRAA Federal Contractor
About Us
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.
About the Team
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.
Salary : $50,500 - $79,000
