About this role
<style type="text/css">table.MiTabla { max-width: 1020px;!important </style> <table border="0" cellspacing="0" cellpadding="0"> <tbody> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554718/SSFF_16_CORP.jpg/cdab49ad-25d9-cb67-8db9-c818cbac0e62?t=1636640425166" alt="" align="top/"></td> </tr> <tr> <td> <p style="text-align:justify">Souhaitez-vous rejoindre une équipe internationale qui travaille à l'amélioration des soins de santé ? Voulez-vous améliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de santé qui, depuis 1909, travaille à l'amélioration de la santé et du bien-être des personnes dans le monde entier. Nous sommes leaders dans le domaine des médicaments dérivés du plasma et de la médecine transfusionnelle et nous développons, produisons et commercialisons des médicaments, des solutions et des services innovants dans plus de 110 pays et régions.</p> </td> </tr> <tr> <td> <p style="text-align:justify">Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.</p> </td> </tr> <tr> <td><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></td> </tr> </tbody> </table><p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Titre du poste : Spécialiste, Assurance Qualité</span></span></p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Relève de : Gestionnaire, Assurance Qualité</span></span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Le Spécialiste AQ – Plasma soutiendra le Centre Logistique Plasma de GCT par diverses tâches liées à la libération des produits plasmatiques, aux vérifications post-don, à la supervision qualité et aux inspections. Le Spécialiste AQ contribuera à la préparation et au soutien des inspections réglementaires, des audits internes ainsi que d’autres projets proactifs de gestion de la qualité.</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Il/elle participera également à l’investigation des écarts concernant les matériaux et le processus de traitement du plasma, en veillant à ce que ces écarts soient traités de manière appropriée, garantissant ainsi un produit fini de meilleure qualité pour les clients potentiels.</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">En outre, les responsabilités suivantes seront également attendues :</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Principales fonctions et responsabilités :</strong></span></span></p> <p> </p> <ul> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Recevoir, enregistrer et évaluer les alertes « lookback » entrantes. Maintenir la documentation des alertes actives et clôturées. S’assurer que toute la documentation provenant du centre de dons est lisible et correcte.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Veiller à ce que les unités de plasma identifiées dans l’alerte « lookback » et faisant partie de l’inventaire interne des centres logistiques (PLC) soient marquées pour retrait dans le système de gestion des stocks.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Veiller à ce que toutes les notifications d’alerte « lookback » reçues soient traitées conformément aux réglementations applicables et aux Procédures Opératoires Normalisées (SOP) établies.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Assister à l’investigation et à la clôture des plaintes clients initiées au centre logistique (PLC).</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Enquêter et rédiger des rapports sur les produits en cours de fabrication/finis et les processus qui ne respectent pas les spécifications de qualité, et documenter ces écarts dans un rapport de déviation.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Participer à la rédaction ou à la révision des politiques et des procédures opératoires normalisées (SOP) liées au traitement du plasma et aux systèmes qualité au GPLC, y compris la participation à la révision annuelle des documents.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Assister à la formation des nouveaux employés en assurance qualité et à la reformation des employés actuels lorsque nécessaire.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Être responsable de la libération qualité (QA) du plasma provenant du PLC et vérifier que tout le contenu des expéditions respecte les procédures opératoires normalisées, les exigences réglementaires et celles des clients avant la libération.</span></li> <li style="color:black;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Créer le certificat de conformité du lot de plasma en utilisant GPOPQD et mettre à jour les méthodes de test SGP.</span></li> <li style="color:black;margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Examiner et vérifier la documentation des températures du centre et du transport afin de garantir la conformité aux spécifications de température appropriées pour la libération des lots</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Débloquer les unités dans SGP et compléter l’évaluation de la conformité du plasma.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Assister l’équipe de direction dans les activités de recherche, telles que l’examen des donneurs sous audit et la création de certificats de conformité pour faciliter la libération des lots.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Effectuer et soutenir les recherches liées aux alertes « lookback » ainsi que l’évaluation des donneurs sous audit.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Effectuer la révision qualité des alertes « lookback » (si applicable).</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Effectuer la révision qualité des documents identifiés par la gestion de la qualité</span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Assumer des responsabilités supplémentaires dans le cadre du programme de système qualité, telles qu’enseignées et assignées.</span></span></li> </ul> <p> </p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong>Exigences requises :</strong></span></span></p> <p> </p> <ul> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Baccalauréat en sciences minimum (de préférence en microbiologie, chimie, biologie) ou expérience professionnelle équivalente ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Au moins 3 ans d'expérience en assurance qualité au sein de l'industrie manufacturière biopharmaceutique ou pharmaceutique ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Expertise de niveau Spécialiste avec une connaissance avancée des systèmes qualité (contrôle des changements, déviations, investigations, analyse des causes fondamentales, CAPA et évaluations des risques) ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Faire preuve de jugement, de compétence technique et de connaissances essentielles au rôle ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Bonnes compétences informatiques avec MS Office et Adobe Acrobat ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Solides compétences organisationnelles, y compris le souci du détail et la capacité à respecter les délais ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Capable d'appliquer, de suivre et de maintenir rigoureusement les règles, les exigences réglementaires, les procédures et les processus ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Capable de travailler de manière autonome et en équipe ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Capable d'effectuer plusieurs tâches à la fois tout en collaborant pour atteindre et dépasser les objectifs ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Diriger les initiatives d'amélioration des pratiques, des processus et de la qualité de l'entreprise ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Soutenir et collaborer activement avec ses collègues ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Faciliter la collaboration interfonctionnelle et gérer les projets assignés ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Bonnes compétences en communication orale et écrite et bonne aptitudes relationnelles ;</span></span></li> <li><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Bilingue en français et en anglais <a name="_Hlk164764151"></a>(la maîtrise de l’anglais est requise pour assurer les échanges de documentations et communications avec d’autres sites de Grifols hors Québec et hors Canada (Espagne, USA).</span></span></li> </ul> <p> </p> <p style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Position title: Quality Assurance Specialist</span></span></p> <p style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Reports to: Quality Assurance Manager</span></span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">The Quality Assurance Specialist (QA) - Plasma, will support the Plasma Logistics Center at GCT through various tasks related to plasma product release, post-donation lookbacks, quality oversight and inspection. The QA specialist will assist in supporting regulatory inspections, internal audits, and other proactive quality management projects. He/she will also assist with investigating deviations of both materials and the plasma processing and ensure these deviations are appropriately handled; therefore, assuring a better finished product for prospective customers. </span><span style="font-size:10.0pt;font-family:Arial, sans-serif">In addition, the following responsibilities will also be expected:</span></p> <p style="margin:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"> </p> <p style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong><u>Key Duties and Responsibilities</u></strong></span></span></p> <p style="text-align:justify"> </p> <ul> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Receives, logs and evaluates incoming lookback alerts. Maintains documentation of active and closed alerts. Ensures all documentation from donor center is legible and correct.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Ensures plasma units identified in the lookback alert that are part of the in-house inventory at the PLCs are marked for removal in inventory control system.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Ensure all Lookback Alert Notifications received are processed in accordance with applicable regulations and established Standard Operating Procedures (SOP).</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Assist with investigation and completion of customer complaints initiated at the PLC.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Investigates and reports in-process/final product and processes that do not meet quality specifications and document in a deviation report.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Participates in the writing or revision of policies and standard operating procedures related to Plasma processing and Quality Systems at GPLC, including participation in annual document review</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Assist with training of new Quality personnel & retraining of current employees when needed</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Responsible for the QA release of plasma from PLC and verifies that all shipment contents meet standard operating procedures, regulatory and customer requirements prior to release.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Create Plasma Lot Certificate of Compliance using GPOPQD and updates to SGP test methods</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Reviews and verifies center and transportation temperature documentation to ensure conformance to appropriate temperature specifications for Lot release.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Unblock units in SGP and complete plasma suitability.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Assist Management team with research activities such as Donors Under Audit, creation of Certificate of Compliance to assist with lot release.</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Perform and support Lookback research and donors under audit evaluation</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Perform QA review of Lookbacks (if applicable)</span></li> <li style="margin-top:0.0cm;margin-right:0.0cm;margin-bottom:0.0cm;font-size:12.0pt;font-family:'Arial Narrow', sans-serif"><span style="font-size:10.0pt;font-family:Arial, sans-serif">Performs quality review of documents as identified by Quality Management.</span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Perform additional Quality System program responsibilities as trained on and assigned</span></span></li> </ul> <p> </p> <p><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><strong><u>Qualifications:</u></strong></span></span></p> <p> </p> <ul> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Education: At minimum, must have a B. Science, (Preferred: Microbiology, Chemistry, Biology) or equivalent job experience</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">At least 3 years’ experience in QA within the Biopharmaceutical or Pharmaceutical manufacturing Industry</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Specialist level expertise with advanced knowledge of quality systems (change control, deviations, investigations, root cause analysis, CAPA and risk assessments)</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Demonstrates judgment, technical competence and knowledge critical for role</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Good computer skills with MS Office and Adobe Acrobat</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Strong organizational skills, including attention to detail and ability to meet deadlines</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Must be able to work independently and as part of a team</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Able to multi-task while collaborating to achieve and exceed goals</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Leads improvement initiatives for organization's practices, processes and quality</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Supports colleagues and actively engages with colleagues </span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Facilitates cross-functional collaboration and manages assigned projects</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Good oral and written communication skills and good interpersonal skills</span></span></li> <li style="text-align:justify"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Bilingual in both French and English <a name="_Hlk164764151"></a>(la maîtrise de l’anglais est requise pour assurer les échanges de documentations et communications avec d’autres sites de Grifols hors Québec et hors Canada (Espagne, USA).</span></span></li> </ul> <h1> </h1> <p> </p><p style="margin-bottom:11.0px"> </p> <p style="margin-bottom:11.0px"><img src="https://staticweb.grifols.com/documents/675849/2554709/SuccesFactors_1020x93_jobposting_line_test.png/e2cffc87-a707-9e08-b5ef-081cae1f1ecf?t=1636640341637" width="100%"></p> <p style="margin-bottom:11.0px"><a title="Politique de confidentialité de Canada" href="https://www.grifols.com/documents/6155530/7740235/Grifols+Canada+-+Careers+Privacy+Notice+FR.pdf/7cf80cab-8124-4560-83fc-21efdafa72a5?t=1753864058480" target="_self">Politique de confidentialité de Canada - Careers</a></p> <p style="margin-bottom:11.0px"><a title="Canada Careers Privacy Notice" href="https://www.grifols.com/documents/6155530/7740235/Grifols+Canada+-+Careers+Privacy+Notice+.pdf/ab5dc5a1-510d-bad0-27c0-60150d169a5e?t=1753864057712" target="_self">Canada Careers Privacy Notice</a></p> <p><strong>Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec</strong> </p> <p> </p> <p><a href="https://www.grifols.com/en/what-we-do" target="_blank" rel="noopener">Learn more about Grifols</a></p> <p> </p>