The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Companyâs unwavering commitment to its mission, Safeguarding Global HealthÂź.
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.
Relevant du gestionnaire de lâassurance qualitĂ© (AQ), le technicien en assurance qualitĂ© est responsable dâassister le gestionnaire AQ afin de sâassurer que les exigences du systĂšme qualitĂ© sont respectĂ©es et maintenues. Ce rĂŽle consiste Ă©galement Ă fournir Ă la direction des informations et des donnĂ©es sur les principaux aspects des opĂ©rations quotidiennes. Ces informations sont utilisĂ©es par la direction de lâusine et du siĂšge social afin de dĂ©terminer si le systĂšme qualitĂ© est adĂ©quat et fonctionne comme prĂ©vu. Le technicien AQ doit interagir efficacement avec les Ă©quipes du service Ă la clientĂšle, des ventes, des opĂ©rations, de la maintenance ainsi quâavec le personnel de lâusine et du siĂšge social, de mĂȘme quâavec les clients et les autoritĂ©s rĂ©glementaires.
Responsabilités principales
• Rédiger des procédures, des déviations, des contrôles de changement et des CAPA
• Rédiger des protocoles et des rapports de validation
• Gérer les spécifications des instructions d’irradiation et la détermination des temps de cycle
• Gérer le programme de lutte antiparasitaire
• Gérer l’inspection des matériaux et l’inventaire
• Gérer le programme d’entretien préventif des équipements
• Effectuer la révision des lots ainsi que la libération des certificats et des produits (sauf pour les produits DEL)
• Effectuer des études de densité sur les produits des clients et compléter les diagrammes de chargement applicables
• Mesure des dosimètres Alanine (Tapetabs)
Qualifications
• Diplôme universitaire d’une université canadienne ou diplôme reconnu comme équivalent par une université ou un organisme d’accréditation canadien en physique, chimie, biologie ou génie
• Minimum de 2 ans d’expérience en assurance qualité dans une entreprise de dispositifs médicaux ou pharmaceutique conforme aux BPF (GMP)
• Une expérience d’au moins 1 an en libération de produits ou dans un environnement de stérilisation est un atout
Compétences et aptitudes
• Bonne connaissance de la norme GUI-0001 et du règlement FDA CFR 21 partie 820
• Expérience en audits qualité (internes et fournisseurs) considérée comme un atout
• Capacité à promouvoir et à soutenir une culture qualité auprès de tous les employés
• Excellentes aptitudes en communication et relations interpersonnelles
• Maîtrise des outils informatiques et capacité à analyser des données dans des bases de données ou des tableurs
• Capacité à travailler sous une charge de travail élevée
• Bilinguisme (anglais et français) requis
Job description
Reporting to the Quality Assurance (QA) Manager, the Quality Assurance Technician is responsible for assisting the QA Manager 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. The QA Technician must effectively interface with Customer Service, Sales, Operations, Maintenance and other plant and corporate staff, as well as customers and regulatory personnel.
Key Responsibilities
- Redact of Procedures, deviation, change control and CAPA
- Redact validation protocol and report
- Manage the irradiation instruction specifications and determination of cycle time
- Manage the pest control program
- Manage the material inspection and inventory
- Manage the equipment preventive maintenance program
- Performs the batch review and release of certificate and product (except for DEL’s products)
- Performs density studies on customer products and complete applicable tote loading diagrams
- Measurement of Alanine Tapetabs
Qualifications
- Minimum university degree from a Canadian university degree, or a degree recognized as equivalent by a Canadian university or Canadian accreditation body in a physic or chemistry or biology or Engineering.
- Minimum of 2 yearsâ experience in Quality Assurance in a GMP medical devices or drug company.
- Experience of 1 year in product release or in sterilization environment preferred.
Skills and Competencies
- Good knowledge of GUI-0001 and FDA CFR 21 part 820.
- Experience in performing quality audits, both internal and suppliers, would be an asset.
- As part of the Quality Assurance team, capable of building and facilitating a quality culture with all employees.
- Strong communication and interpersonal skills
- Should be proficient using a computer and be able to analyze data in a database/spreadsheet
- Must be used to high workload
- Must be bilingual in English and French
Sotera Health goes to market through its three best-in-class businesses â SterigenicsÂź, NordionÂź and Nelson LabsÂź. 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.
