Job Title

Job Title & Company Analyste en chimie, Contrle qualit (Nuits) - Quality Control Analyst I - Chemistry (Nights) Grifols Souhaitez-vous rejoindre une quipe internationale qui travaille l'amlioration des soins de sant ? Voulez-vous amliorer la vie de millions de personnes ? Grifols est une entreprise mondiale de soins de sant qui, depuis 1909, travaille l'amlioration de la sant et du bientre des personnes dans le monde entier. Nous sommes leaders dans le domaine des mdicaments drivs du plasma et de la mdecine transfusionnelle et nous dveloppons, produisons et commercialisons des mdicaments, des solutions et des services innovants dans plus de 110 pays et rgions. 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 wellbeing of people around the world. We are leaders in plasmaderived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions. Position Title Quality Control Analyst, Chemistry (Night shift: 10:30 pm 7:00 am) Reports To Supervisor, Chemistry Quality Control Key Duties And Responsibilities Perform identification test for chemicals. Ensure all equipment used in the inspection and testing processes are calibrated. Maintain Instrument Usage and Calibration Logs based on instrument usage during the preparation and testing of samples. Monitor and maintain the inventory level of supplies used. Perform all lab functions in compliance with cGMP. Writing and reviewing SOPs. Perform Raw Materiel testing according to USP, EP and BP. Perform analytical testing on raw material, packaging components, utilities and other test articles as per approved methods, specifications, procedures and GMP. Ability to perform techniques using UV spectrophotometry, HPLC, GC, and AAS and TOC. Perform QC instrument verification and qualification as needed. Provide lab support including reagent preparation, cleaning, and routine equipment maintenance. Recognize and report aberrant test results and sample conditions. Report any out-of-specification (OOS), out-of-trend (OOT) or atypical results immediately to the QC Manager and participate in laboratory investigations, as required. Ensure training is current for all job functions performed. Order, stock and receive laboratory supplies. Complete all required documentation legibly and accurately. Maintain Good Documentation Practices when completing logbooks, analytical work sheets, training records and all other GMP documents. Ensure the integrity and traceability of data generated. Collaborate with QC Supervisor and Manager to optimize laboratory efficiencies, support lab coordination and provide input to method transfer and analytical method validation studies. Perform additional duties as assigned. Fonctions Et Responsabilits Cls Effectuer des tests d'identification pour tous les contenants de produits chimiques. S'assurer que tous les quipements utiliss dans les processus d'inspection et d'essai sont talonns. Tenir jour les registres d'utilisation et d'talonnage des instruments en fonction de leur utilisation pendant la prparation et l'analyse des chantillons. Contrler et maintenir le niveau d'inventaire des fournitures utilises dans le processus d'inspection. Effectuer toutes les fonctions de laboratoire en conformit avec les BPF. Rdiger et rviser les PONs. Effectuer des tests sur les matires premires conformment USP, EP et BP. Effectuer des tests analytiques sur les matires premires, les composants d'emballage, les utilitaires et autres articles de test conformment aux mthodes, spcifications et procdures approuves et aux BPF. Capacit raliser des techniques utilisant la spectrophotomtrie UV, HPLC, GC, AAS et TOC. Effectuer la vrification et la qualification des instruments de Contrle Qualit selon les besoins. Fournir un soutien au laboratoire, y compris la prparation des ractifs, le nettoyage et l'entretien courant de l'quipement. Reconnatre et signaler les rsultats de tests et les conditions d'chantillons aberrants. Signaler immdiatement au responsable du Contrle Qualit tout rsultat hors spcifications (OOS), hors tendance (OOT) ou atypique et participer aux investigations du laboratoire, le cas chant. S'assurer que la formation est jour pour toutes les fonctions exerces. Commander, stocker et recevoir les fournitures de laboratoire. Remplir tous les documents requis de manire lisible et prcise. Respecter les bonnes pratiques de documentation en remplissant les journaux de bord, les feuilles de travail analytiques, les dossiers de formation et tous les autres documents relatifs aux BPF. Assurer l'intgrit et le suivi des donnes gnres. Collaborer avec le Superviseur et le Gestionnaire du contrle qualit pour optimiser l'efficacit du laboratoire, soutenir la coordination du laboratoire et contribuer aux tudes de transfert de mthodes et de validation des mthodes analytiques. Effectuer des tches supplmentaires selon les besoins. Qualifications Minimum of a bachelors degree in a scientific (Chemistry or Biochemistry) or related scientific discipline and experience in a Biotech or pharmaceutical QC Laboratory preferred. GMP experience required. A working knowledge of the cGMP QC laboratory environment, and equipment associated with testing of biopharmaceutical products. Related experience: Minimum of 3 years of working experience in a GMP laboratory role. Knowledge of GMP as well as pharmacopeia (USP, BP, EP) to support products intended for the Canadian, US and European market. Knowledge of cGMPs, good documentation practices and data integrity requirements. Experience with LIMS systems preferred. Strong computer skills with MS Office (MS Word and Excel). Strong organizational skills, including attention to detail and ability to meet deadlines. Able to rigorously apply, follow and maintain rules, regulatory requirements, procedures and processes. Ability to follow written procedures with close attention to detail. Must be able to work independently and as part of a team. Able to multi-task under strict deadlines. Be proactive and resourceful to help prevent and solve problems. Excellent oral and written communication skills and good interpersonal skills. Bilingual in both French and English. Lexigence de langlais est requise pour la documentation, les rapports et les interactions avec Sant Canada, FDA, et autres dpartements multi-disciplinaires dans lentreprise mais bass hors-Qubec et hors-Canada (Espagne, USA). Location NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec Seniority level Mid-Senior level Employment type Full-time Job function Research, Analyst, and Information Technology Industries Pharmaceutical Manufacturing and Medical Equipment Manufacturing #J-18808-Ljbffr