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 Instrumentation Specialist Reports to: QC Manager

Position Summary

The QC Instrumentation Specialist is responsible for supporting the qualification of laboratory instruments and to coordinate the maintenance and calibration programs for systems and Controlled temperature unit (Fridges, Freezers, and Incubators) in operation at the QC Laboratories at Grifols Canada Therapeutics Inc. The responsibilities for this position require a strong background in laboratory instrumentation to support QC laboratory systems and Equipment Activities.

Key Duties and Responsibilities

Installation, maintenance, diagnosis and troubleshooting of the laboratory analytical equipment (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer , MALDI Biotyper , Endotoxin System, ELISA).

Maintains and reviews calibration data associated with QC laboratory standards and trends changes in standard or assay performance.

Provides the expertise required to generate installation/operation/performance qualifications for sophisticated QC laboratory instrumentation

Help to Generates IQ/OQ/PQ and validation reports for QC instrumentation

Develop or update Calibration Standard Procedures

Assists the QC department in troubleshooting or investigating instrument

Notifies QC management of any potential quality issues related to Lab instrumentations and provide recommendations for quality improvement

Assists in the resolution of audit observations related to validations and proposes corrective actions.

Coordination of the instrument maintenance and spare parts inventory as well as coordination with vendors.

Use computers and or Advanced Maintenance Management System (SAP) to gather information for analysis regarding calibrations and Preventive maintenances

Qualifications:

B.Sc. (preferred) in Biochemistry, Physics, or a Life Sciences field

Requires at least six years of experience working in the same position in a Quality Control laboratory in a cGMP environment such as is found in the pharmaceutical or biotech industry.

Experience in an FDA regulated manufacturing facility - pharmaceutical, biologics, biotech, with knowledge of cGMPs, FDA regulations, and industry guidelines is preferred. Experience in Q is a plus. Knowledge of calibration, quality control instrumentation, must have strong trouble shooting abilities to identify and resolve equipment problems. Able to repair, calibrate, install.

Strong communication, interpersonal, organizational, and decision-making skills. Strong technical writing skills. Requires a fundamental understanding of analytical methodology, protein biochemistry, immunochemistry, chromatography, electrophoresis, spectroscopy, and ELISA. Requires an advanced knowledge and skill level for computerized systems used with laboratory equipment.

Knowledge of GMP as well as pharmacopeia (USP, BP, EP) to support products intended for the Canadian, US and European markets.

Advanced knowledge of automated and computerized systems qualification, data integrity requirements and computer system validation for lab system applications.

Expert level MS Office skills and solid experience with IT systems related to pharmaceutical applications.

Bilingual English/French.

Position: Sp\xc3\xa9cialiste QC Instrumentation Rapporte au: QC Manager

Sommaire du poste :

Le sp\xc3\xa9cialiste en instrumentation au contr\xc3\xb4le de Qualit\xc3\xa9 (QC) est responsable de soutenir la qualification des instruments de laboratoire et des unit\xc3\xa9s \xc3\xa0 temp\xc3\xa9rature contr\xc3\xb4l\xc3\xa9e (r\xc3\xa9frig\xc3\xa9rateurs, cong\xc3\xa9lateurs et incubateurs) et de coordonner les programmes d\'entretien et d\'\xc3\xa9talonnage de ces Instruments et Unit\xc3\xa9s au QC Grifols Therapeutics Canada Inc. Les responsabilit\xc3\xa9s de ce poste n\xc3\xa9cessite une solide exp\xc3\xa9rience en instrumentation de laboratoire .

T\xc3\xa2ches et r\xc3\xa9sponsabilit\xc3\xa9s:

Installation, maintenance, diagnostic et d\xc3\xa9pannage des \xc3\xa9quipements analytiques du laboratoire (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer, MALDI Biotyper, Endotoxin System, ELISA).

Maintient et examine les donn\xc3\xa9es d\'\xc3\xa9talonnage associ\xc3\xa9es aux Instruemnts et rapporter les changements dans les performances.

Fournit l\'expertise requise pour g\xc3\xa9rer les qualifications d\'installation/de fonctionnement et de performance des instruments de laboratoire QC.

Aide \xc3\xa0 la redaction des rapports IQ/OQ/PQ et de validation pour les instruments du Laboratoire

D\xc3\xa9velopper et/ou mettre \xc3\xa0 jour les proc\xc3\xa9dures de calibration et d\'\xc3\xa9talonnage des \xc3\xa9quipements

Assiste le d\xc3\xa9partement QC pour mener toute investigation reli\xc3\xa9es aux Instruments et des unit\xc3\xa9s \xc3\xa0 temp\xc3\xa9rature contr\xc3\xb4l\xc3\xa9es

Avertir le Responsable du Laboratoire QC de tout probl\xc3\xa8me de qualit\xc3\xa9 potentiel li\xc3\xa9 aux instruments et aux Unit\xc3\xa9s de temp\xc3\xa9ratures contr\xc3\xb4l\xc3\xa9es de laboratoire et fournit des recommandations pour l\'am\xc3\xa9lioration de la qualit\xc3\xa9

Aide \xc3\xa0 instaurer les Actions correctives reli\xc3\xa9es aux observations d\'audit li\xc3\xa9es aux validations des instruments.

Coordination de la Calibration et maintenance des instruments et de l\'inventaire des pi\xc3\xa8ces de rechange ainsi que la coordination avec les fournisseurs.

Connaissance avanc\xc3\xa9e de gestion de la maintenance Via (SAP) pour recueillir des informations concernant les \xc3\xa9talonnages et les maintenances pr\xc3\xa9ventives.

Qualifications:

B.Sc. (de preference) en biochimie, en physique ou dans un Domaine des sciences de la vie

Ayant au moins six ans d\'exp\xc3\xa9rience dans le m\xc3\xaame poste dans un laboratoire de contr\xc3\xb4le de la qualit\xc3\xa9 dans un environnement cGMP dans l\'industrie pharmaceutique ou biotechnologique.

Solides comp\xc3\xa9tences en communication, en relations interpersonnelles, en organisation et en prise de d\xc3\xa9cision. Solides comp\xc3\xa9tences en r\xc3\xa9daction technique N\xc3\xa9cessite un niveau avanc\xc3\xa9 de connaissances et de comp\xc3\xa9tences pour les syst\xc3\xa8mes informatis\xc3\xa9s utilis\xc3\xa9s avec l\'\xc3\xa9quipement de laboratoire.

Connaissance des BPF ainsi que des pharmacop\xc3\xa9es (USP, BP, EP) pour supporter les produits destin\xc3\xa9s aux march\xc3\xa9s canadien, am\xc3\xa9ricain et europ\xc3\xa9en.

Connaissance avanc\xc3\xa9e de la qualification des Syst\xc3\xa8me informatis\xc3\xa9 analytique, des exigences d\'int\xc3\xa9grit\xc3\xa9 des donn\xc3\xa9es et de la validation des syst\xc3\xa8mes informatiques pour les applications des syst\xc3\xa8mes de laboratoire.

Comp\xc3\xa9tences en MS Office ( Excel, Word et Power point) et solide exp\xc3\xa9rience des logiciel des syst\xc3\xa8mes li\xc3\xa9s aux applications pharmaceutiques.

Bilingue anglais/fran\xc3\xa7ais.

Location: NORTH AMERICA : Canada : Montreal || NORTH AMERICA : Canada : AB-Alberta || NORTH AMERICA : Canada : BC-British Columbia || NORTH AMERICA : Canada : Mississauga || NORTH AMERICA : Canada : ON-Ontario || NORTH AMERICA : Canada : QC-Quebec:CAQUEBEC - Quebec

Grifols