Quality Assurance Technician

Sterigenics; Bell (CA); On-site; USD 53,000 - 83,000; Full time

Job summary

Sotera Health (Sterigenics U.S. LLC) is seeking a Quality Assurance Technician for our Bell, CA facility. You will assist the Plant QA Manager and Validation Coordinator to ensure the quality system remains effective and ready for audits.

Responsibilities include providing data on quality status, supporting corrective actions, reviewing batch records, and assisting with FDA/ISO/GMP audits and validations. Candidates should have a High School Diploma, 1–1.5 years in a sterilization setting, and

Qualifications

• High School Diploma or GED required; 1–1.5 years sterilization environment preferred.
• Must read, write and speak fluent English.
• Proficient with computers and data analysis in spreadsheets/databases.

Responsibilities

• Provide data reflecting the status of the plant quality system.
• Assist with corrective actions and process improvements, including retraining.
• Monitor batch records (temperature, humidity data) and ensure integrity of information.

Skills

Fluent English (reading/writing)

Data analysis in database/spreadsheet

Team collaboration

Education

High School Diploma or GED

Tools

Spreadsheet software

Database software

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, & SafetyProvides 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 ReportAssists 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.QualificationsHigh 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 RequirementsMust 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 RequiredMust complete all required training for a “Quality Assurance Technician” outlined in the training manual.Benefits and Pay RatePay Rate: $53,000 to $83,000 annually, based on experience. Compensation is paid at an hourly rateSotera Health offers a competitive benefits package that includes:Medical, Rx, Dental, Vision, Disability, Life Insurance, Health Savings and Flexible Spending Accounts401(k) program with Company match that immediately vestsPaid holidays, vacation and sick timeFree financial planning assistancePaid parental leaveEducation assistanceVoluntary benefits including Critical Illness, Accident, Hospital Indemnity and Pet InsuranceEmployee 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 ContractorSotera 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.