Qc Instrumentation Specialist 1

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.
- Bilingual English/French.

**Position**:Spécialiste QC Instrumentation **Rapporte au**: QC Manager

**Sommaire du poste**:
Le spécialiste en instrumentation au contrôle de Qualité (QC) est responsable de soutenir la qualification des instruments de laboratoire et des unités à température contrôlée (réfrigérateurs, congélateurs et incubateurs) et de coordonner les programmes d'entretien et d'étalonnage de ces Instruments et Unités au QC Grifols Therapeutics Canada Inc. Les responsabilit
- s de ce poste nécessite une solide expérience en instrumentation de laboratoire.

**Tâches et résponsabilités**:

- Installation, maintenance, diagnostic et dépannage des équipements analytiques du laboratoire (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer, MALDI Biotyper, Endotoxin System, ELISA).
- Maintient et examine les données d'étalonnage associées aux Instruemnts et rapporter les changements dans les performances.
- Fournit l'expertise requise pour gérer les qualifications d'installation/de fonctionnement et de performance des instruments de laboratoire QC.
- Aide à la redaction des rapports IQ/OQ/PQ et de validation pour les instruments du Laboratoire
- Développer et/ou mettre à jour les procédures de calibration et d’étalonnage des équipements
- Assiste le département QC pour mener toute investigation reliées aux Instruments et des unités à température contrôlées
- Avertir le Responsable du Laboratoire QC de tout problème de qualité potentiel lié aux instruments et aux Uni