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 provide…
Skills: Quality Assurance, Data Analysis, Regulatory Compliance, FDA Compliance, ISO Compliance
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 provide…
Skills: System Monitoring, Equipment Maintenance, Forklift Operation, Process Documentation, Safety Compliance
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 provide…
Skills: Quality Assurance, Regulatory Compliance, Process Improvement, Corrective Actions, Change Control
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 provide…
Skills: System Monitoring, Equipment Maintenance, Forklift Operation, Process Documentation, Safety Compliance
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 provide…
Skills: System Monitoring, Equipment Maintenance, Forklift Operation, Process Documentation, Safety Compliance
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 provide…
Skills: General Management, Leadership, Operations Management
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 provide…
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 provide…
Charlotte, North Carolina, United States · On-site
Mid level$3.8B raised
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 provide…
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 provide…
Charlotte, North Carolina, United States · On-site
Entry level$3.8B raised
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 provide…
Skills: System Monitoring, Equipment Maintenance, Forklift Operation, Process Documentation, Safety Compliance
Haw River, North Carolina, United States · On-site
Entry level$3.8B raised
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 provide…
Skills: System Monitoring, Equipment Maintenance, Forklift Operation, Process Documentation, Safety Compliance
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 provide…
Skills: Preventative Maintenance, Mechanical Troubleshooting, Electrical Troubleshooting, Ladder Logic, 480 Volt 3 Phase Power
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 provide…
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$38k–$54k/yr
Full-time
high school
Medical, Rx, Dental, Vision, Disability, Life Insurance
Posted 50d ago
~40 hrs/week
Responsibilities
The QA Technician assists the Plant QA Manager in maintaining quality system requirements and providing data for operational decision-making. Key duties include monitoring batch records, executing validation studies, and supporting regulatory audits.
Requirements
Candidates must have a High School Diploma or GED and are preferred to have 1 to 1.5 years of experience in a sterilization environment. Physical requirements include the ability to lift 50 pounds and tolerate high temperature and humidity conditions.
Full job description
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: $37,500–$54,000 annually, based on experience. Compensation is paid at an hourly rate
Sotera Health offers a competitive benefits package that includes:
Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts
401(k) program with Company match that immediately vests
Paid holidays, vacation and sick time
Free financial planning assistance
Paid parental leave
Education assistance
Voluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet Insurance
Employee Assistance Program (EAP)
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. 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.
Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena. Working as a team, Sotera Health and its companies have one common goal: Safeguarding Global Health®. With these three companies operating together, Sotera Health, formerly Sterigenics International, leverages more than 500 combined years of scientific expertise to ensure safety across the medical device, pharma, tissue and food industries. With over 2,800 employees globally, including more than 350 scientists, the company operates 63 facilities worldwide across 13 countries. Our purpose is bigger than the products and services we provide. We ensure that health care around the world is consistently and reliably safe every day. Our purpose, our conduct, and our values are at the heart of our commitment to employee safety, environmental responsibility, and sustainability principles.
The Sotera Health name is new, but our track record for reliability and safety in global health is well established. Formed in 2017 as the parent company for Nelson Labs, Nordion and Sterigenics, Sotera Health is the leader in protecting global health thanks to the longstanding reputation for quality across each of its companies. In aggregate, Sotera Health has over 185 years of combined industry leadership. Sterigenics has provided safe sterilization services since the 1930s. Nordion has established expertise in gamma technologies and medical isotopes since 1946. Nelson Labs has provided expert lab testing since 1985. Our most recent addition to the Sotera Health family, Toxikon Europe, has established a leading extractables and leachables testing platform since 1990. An impressive history that points to an even brighter future.
Offices: 9100 South Hills Blvd, Suite 300, Broadview Heights, Ohio 44147, US
Safeguarding Global HealthSterilization TechnologiesLab TestingAdvisory Servicesand Sterilization SolutionsHealth CareMedical DeviceBiotechnology
Sotera Health brings together Sterigenics, Nelson Labs and Nordion, each of which are established, highly reputable players in the global health arena. Working as a team, Sotera Health and its companies have one common goal: Safeguarding Global Health®. With these three companies operating together, Sotera Health, formerly Sterigenics International, leverages more than 500 combined years of scientific expertise to ensure safety across the medical device, pharma, tissue and food industries. With over 2,800 employees globally, including more than 350 scientists, the company operates 63 facilities worldwide across 13 countries. Our purpose is bigger than the products and services we provide. We ensure that health care around the world is consistently and reliably safe every day. Our purpose, our conduct, and our values are at the heart of our commitment to employee safety, environmental responsibility, and sustainability principles.
The Sotera Health name is new, but our track record for reliability and safety in global health is well established. Formed in 2017 as the parent company for Nelson Labs, Nordion and Sterigenics, Sotera Health is the leader in protecting global health thanks to the longstanding reputation for quality across each of its companies. In aggregate, Sotera Health has over 185 years of combined industry leadership. Sterigenics has provided safe sterilization services since the 1930s. Nordion has established expertise in gamma technologies and medical isotopes since 1946. Nelson Labs has provided expert lab testing since 1985. Our most recent addition to the Sotera Health family, Toxikon Europe, has established a leading extractables and leachables testing platform since 1990. An impressive history that points to an even brighter future.
Offices: 9100 South Hills Blvd, Suite 300, Broadview Heights, Ohio 44147, US
Safeguarding Global HealthSterilization TechnologiesLab TestingAdvisory Servicesand Sterilization SolutionsHealth CareMedical DeviceBiotechnology