Quality Assurance Technician

Résumé du poste

Relevant du gestionnaire de l’assurance de la qualité (AQ), le technicien du contrôle de la qualité est chargé d’aider le gestionnaire de l’AQ à s’assurer que les exigences du système de qualité sont respectées et maintenues. Ce rôle aide à fournir à la direction de l’information qui est utilisée par la direction de l’usine et de l’entreprise pour déterminer si le système qualité est adéquat et fonctionne comme prévu. 

Principales responsabilités

• Effectue la dosimétrie
• Rédaction de rapport de validation
• Étalonner les instruments utilisés dans les systèmes de sécurité et de dosimétrie
• Gestion du système d’eau
• Rédaction et exécution de CAPA, CC et Déviation
• Assiste à toutes les activités pertinentes pour les audits clients et réglementaires
• Effectue l’examen du lot et la libération du certificat
• Effectue des études de densité sur les produits des clients et complète les diagrammes de charge
• Aide le gestionnaire de l’AQ dans tout autre taches

Qualifications requises

• Baccalauréat en sciences (physique, chimie ou biologie)
• Minimum d’un (1) an d’expérience de travail dans un environnement BPF sous la réglementation GUI-0001 et/ou ISO 13485
• Doit être compétent à l’aide d’un ordinateur et être en mesure d’analyser les données dans une base de données / feuille de calcul avec Excel

Exigences particulières

Doit être bilingue en français et en anglais

Position Summary

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.

Key Responsibilities

• Execute routine dosimetry and reconciliation
• Performs density studies on customer products and complete applicable tote loading diagrams
• Execute calibration of instruments used in safety and dosimetry systems
• Redaction and Execution of CAPA, Deviation and Deficiency
• Assists the QA Manager in all activities relevant for customer and regulatory audits
• Assists the Validation Coordinator with validations and calibrations
• Other QA/Validation duties as assigned
• Performs the batch review and release of certificate
• Provides backup support for the QA Manager in a variety of functions
• Assists with other tasks assigned by Supervisor

Qualifications

• Baccalaureate in science (physical, chemistry or biology)
• Minimum One (1) years of experience working in a GMP environment under standard of GUI-0001 and/or ISO 13485
• Should be proficient using a computer and be able to analyze data in a database/spreadsheet in Excel

Special Requirements:

Must be bilingual in English and French

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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