Job Description

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Position Title: QC Analyst II (QC Chemistry) Reports to: QC Chemistry Supervisor

Purpose Statement

The Quality Control (QC) Analyst II is responsible for performing analytical tests in chemistry daily lab operations and execution of testing to support manufacturing operations or validation. Testing typically includes samples from raw materials, in-process intermediates, final drug product manufacturing, stability and various protocol studies using approved test methods. This position requires competent understanding and ability to perform techniques such as

This position is expected to maintain operational and GMP readiness of the QC areas. Based on the level of this position, the individual in the Analyst II role is expected to participate in more complex projects including QC studies and to develop mastery of a diverse number of analytical techniques and fluency with analytical technologies.

Key Duties and Responsibilities

• Perform all lab functions in compliance with cGMP.
• Writing and reviewing SOPs
• Perform Raw Materiel testing according to USP , EP and BP
• Perform Finish product, utilities testing for GMP use in manufacturing. Follow written procedures for the following tests as trained and qualified:

• Electrophoresis (SDS-PAGE)
• ELISA testing
• UV - Vis Spectrophotometer
• Compendial Methods such as pH, Osmolality, and Appearance.
• TOC Analyzer
• Atomic Absorption Spectroscopy (AAS)
• Gas chromatography
• HPLC

• Perform analytical testing on raw material, intermediates, packaging components, finished product, utilities and other test articles as per approved methods, specifications, procedures and GMP.
• 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.
• Receive and manage samples that come into the lab for stability and release testing.
• 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
• Support the implementation of Laboratory Information Management System (LIMS) with the data entry and configuration of the future LIMS or SAP applications.
• Assist in management of retention and stability samples, as well as samples for destruction
• Collaborate with QC Supervisor and Director to optimize laboratory efficiencies, support lab coordination and provide input to method transfer and analytical method validation studies.
• Coordinate the maintenance of equipment and facilities, and ensure adherence to calibration schedules.
• Perform additional duties as assigned

Qualifications

• Minimum of a bachelor\'s 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 5 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 an 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 preferred

Titre du poste: Analyste CQ II (Chimie CQ) Rel\xc3\xa8ve du : Superviseur, Chimie CQ

Objectif

L\'analyste du contr\xc3\xb4le de la qualit\xc3\xa9 (CQ) II est responsable de l\'ex\xc3\xa9cution des tests analytiques dans le cadre des activit\xc3\xa9s quotidiennes du laboratoire de chimie et de l\'ex\xc3\xa9cution des tests pour appuyer les op\xc3\xa9rations de fabrication ou la validation. Les essais comprennent g\xc3\xa9n\xc3\xa9ralement des \xc3\xa9chantillons de mati\xc3\xa8res premi\xc3\xa8res, de produits interm\xc3\xa9diaires en cours de fabrication, de produits pharmaceutiques finis, de stabilit\xc3\xa9 et de divers protocoles d\'\xc3\xa9tudes utilisant des m\xc3\xa9thodes d\'essai approuv\xc3\xa9es. Ce poste exige une compr\xc3\xa9hension comp\xc3\xa9tente et la capacit\xc3\xa9 d\'ex\xc3\xa9cuter des techniques telles que la teneur en prot\xc3\xa9ines, l\'\xc3\xa9lectrophor\xc3\xa8se, l\'ELISA, la spectrophotom\xc3\xa9trie UV, la HPLC, la GC et l\'AAS.

Ce poste doit permettre de maintenir l\'\xc3\xa9tat de pr\xc3\xa9paration op\xc3\xa9rationnelle et BPF des zones de CQ. En fonction du niveau de ce poste, la personne occupant le poste d\'analyste II devra participer \xc3\xa0 des projets plus complexes, y compris des \xc3\xa9tudes de contr\xc3\xb4le de la qualit\xc3\xa9, et acqu\xc3\xa9rir la ma\xc3\xaetrise d\'un grand nombre de techniques analytiques et de technologies analytiques.

Fonctions et responsabilit\xc3\xa9s cl\xc3\xa9s

- Effectuer toutes les fonctions de laboratoire en conformit\xc3\xa9 avec les cGMP.

- R\xc3\xa9diger et r\xc3\xa9viser les SOPs

- Effectuer des tests sur les mati\xc3\xa8res premi\xc3\xa8res conform\xc3\xa9ment aux normes USP, EP et BP.

- Effectuer des tests sur les produits finis et les utilit\xc3\xa9s pour une utilisation BPF dans la fabrication. Suivre les proc\xc3\xa9dures \xc3\xa9crites pour les tests suivants selon la formation et les qualifications:

o Teneur en prot\xc3\xa9ines (Kjeldahl, Biuret)

o Electrophor\xc3\xa8se (SDS-PAGE)

o Test ELISA

o Spectrophotom\xc3\xa8tre UV - Vis

o M\xc3\xa9thodes officinales telles que le pH, l\'osmolalit\xc3\xa9 et l\'apparence.

o Analyseur de COT

o Spectroscopie d\'absorption atomique (AAS)

o Chromatographie en phase gazeuse

o HPLC

- Effectuer des tests analytiques sur les mati\xc3\xa8res premi\xc3\xa8res, les produits interm\xc3\xa9diaires, les composants d\'emballage, les produits finis, les utilitaires et autres articles d\'essai conform\xc3\xa9ment aux m\xc3\xa9thodes, sp\xc3\xa9cifications et proc\xc3\xa9dures approuv\xc3\xa9es et aux BPF.

- Effectuer la v\xc3\xa9rification et la qualification des instruments de CQ selon les besoins.

- Fournir un soutien au laboratoire, y compris la pr\xc3\xa9paration des r\xc3\xa9actifs, le nettoyage et l\'entretien courant de l\'\xc3\xa9quipement.

- Reconna\xc3\xaetre et signaler les r\xc3\xa9sultats d\'essais et les conditions d\'\xc3\xa9chantillons aberrants. Signaler imm\xc3\xa9diatement au responsable du CQ tout r\xc3\xa9sultat hors sp\xc3\xa9cification (OOS), hors tendance (OOT) ou atypique et participer aux investigations du laboratoire, le cas \xc3\xa9ch\xc3\xa9ant.

- S\'assurer que la formation est \xc3\xa0 jour pour toutes les fonctions exerc\xc3\xa9es.

- Recevoir et g\xc3\xa9rer les \xc3\xa9chantillons qui arrivent au laboratoire pour les tests de stabilit\xc3\xa9 et de lib\xc3\xa9ration.

- Commander, stocker et recevoir les fournitures de laboratoire.

- Remplir tous les documents requis de mani\xc3\xa8re lisible et pr\xc3\xa9cise. 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\'int\xc3\xa9grit\xc3\xa9 et le suivi des donn\xc3\xa9es g\xc3\xa9n\xc3\xa9r\xc3\xa9es

- Soutenir la mise en \xc5\x93uvre du syst\xc3\xa8me de gestion des informations de laboratoire (LIMS) avec la saisie des donn\xc3\xa9es et la configuration du futur LIMS ou des applications SAP.

- Aider \xc3\xa0 la gestion des \xc3\xa9chantillons de r\xc3\xa9tention et de stabilit\xc3\xa9, ainsi que des \xc3\xa9chantillons \xc3\xa0 d\xc3\xa9truire.

- Collaborer avec le superviseur et le directeur du CQ pour optimiser l\'efficacit\xc3\xa9 du laboratoire, soutenir la coordination du laboratoire et contribuer aux \xc3\xa9tudes de transfert de m\xc3\xa9thodes et de validation des m\xc3\xa9thodes analytiques.

- Coordonner l\'entretien de l\'\xc3\xa9quipement et des installations, et veiller au respect des calendriers d\'\xc3\xa9talonnage.

- Effectuer des t\xc3\xa2ches suppl\xc3\xa9mentaires selon les besoins.

Qualifications

- Minimum d\'un baccalaur\xc3\xa9at dans une discipline scientifique (chimie ou biochimie) ou une discipline scientifique connexe et exp\xc3\xa9rience dans un laboratoire de CQ biotechnologique ou pharmaceutique de pr\xc3\xa9f\xc3\xa9rence. Exp\xc3\xa9rience GMP requise.

- Une connaissance pratique de l\'environnement de laboratoire CQ cGMP et de l\'\xc3\xa9quipement associ\xc3\xa9 aux essais des produits biopharmaceutiques.

- Exp\xc3\xa9rience connexe: Minimum de 5 ans d\'exp\xc3\xa9rience professionnelle dans un r\xc3\xb4le de laboratoire GMP.

- Connaissance des BPF ainsi que de la pharmacop\xc3\xa9e (USP, BP, EP) pour soutenir les produits destin\xc3\xa9s au march\xc3\xa9 canadien, am\xc3\xa9ricain et europ\xc3\xa9en.

- Connaissance des BPF, des bonnes pratiques de documentation et des exigences en mati\xc3\xa8re d\'int\xc3\xa9grit\xc3\xa9 des donn\xc3\xa9es.

- Exp\xc3\xa9rience des syst\xc3\xa8mes LIMS souhait\xc3\xa9e.

- Solides comp\xc3\xa9tences informatiques avec MS Office (MS Word et Excel).

- Solides comp\xc3\xa9tences organisationnelles, y compris le souci du d\xc3\xa9tail et la capacit\xc3\xa9 \xc3\xa0 respecter les d\xc3\xa9lais.

- Capacit\xc3\xa9 \xc3\xa0 appliquer, suivre et maintenir rigoureusement les r\xc3\xa8gles, les exigences r\xc3\xa9glementaires, les proc\xc3\xa9dures et les processus.

- Capacit\xc3\xa9 \xc3\xa0 suivre des proc\xc3\xa9dures \xc3\xa9crites en portant une attention particuli\xc3\xa8re aux d\xc3\xa9tails.

- Doit \xc3\xaatre capable de travailler de mani\xc3\xa8re ind\xc3\xa9pendante et en \xc3\xa9quipe.

- \xc3\x8atre capable d\'effectuer plusieurs t\xc3\xa2ches dans des d\xc3\xa9lais stricts

- \xc3\x8atre proactif et d\xc3\xa9brouillard pour aider \xc3\xa0 pr\xc3\xa9venir et \xc3\xa0 r\xc3\xa9soudre les probl\xc3\xa8mes

- Excellentes comp\xc3\xa9tences en communication orale et \xc3\xa9crite et bonnes aptitudes interpersonnelles.

- Bilingue (fran\xc3\xa7ais et anglais) de pr\xc3\xa9f\xc3\xa9rence

Location: NORTH AMERICA : Canada : Montreal:CAQUEBEC - Quebec

Grifols