What are the responsibilities and job description for the Manager Quality Assurance position at Sotera Health Services, LLC?
Job Description
Reporting to the General Manager, the Quality Assurance (QA) Manager is directly responsible for managing and coordinating all quality functions for the facility. He / She maintains responsibility for all aspects connected with compliance, including the development, analysis and reporting of support data for regulatory agencies and Corporate Quality. In addition, he / she is responsible for addressing all quality issues in a timely fashion and communicating that information to the site as required. The Quality Assurance Manager is responsible to assure compliance with all corporate and government procedures and regulations and serves as the Management Representative and Responsible Engineering Manager for the facility.
Responsibilities
- Quality, Regulatory & Safety
- Maintains compliance with all regulatory requirements to include : FDA, OSHA, EPA, USDA and NRC as applicable.
- Actively pursues continuous process and quality improvement as measured by internal indices and external audits / reports.
- Coordinates activities relating to determining and reporting causes of non-conformances, as well as implementing corrective actions and process improvements; assist in appropriate retraining.
- Initiates and / or oversees change control process.
- Analysis of facility data for identification of trends and initiation of required actions.
- Coordinates all activities relevant to FDA, ISO, customer, Internal & other regulatory audits.
- Conducts internal compliance audits as required and maintains appropriate records.
- Maintains facility quality records and procedures.
- Coordinates and maintains personnel dosimetry records.
- Coordinates with plant Operations all system requalification activities as applicable.
- Assists Corporate Quality Assurance with special projects and assignments as requested.
- Coordinates facility management reviews.
- Coordinates and maintains facility risk analysis.
- Coordinates environmental monitoring and maintains personnel badge testing records.
- Executes Equivalency and Retrospective Revalidation studies / report where applicable.
Operations
Human Resources
Qualifications
Training Required
Pay & Benefits
Salary Range : $87,500 - $142,000 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 : $87,500 - $142,000
