About the role

QC Instrumentation Specialist at Grifols supporting qualification and maintenance of laboratory instruments. Collaborating with QC teams to ensure compliance with industry standards in a cGMP environment.

Responsibilities

Install, maintain, diagnose and troubleshoot laboratory analytical equipment (TOC, HPLC, GC, IR, UV-VIS, IC, Karl Fischer, MALDI Biotyper, Endotoxin System, ELISA).
Maintain and review calibration data associated with instruments and report changes in performance.
Provide the expertise required to manage installation/operational and performance qualifications (IQ/OQ/PQ) for quality control laboratory instruments.
Assist in preparing IQ/OQ/PQ and validation reports for laboratory instruments.
Develop and/or update equipment calibration and verification procedures.
Support the QC department in investigations related to instruments and temperature-controlled units.
Notify the QC Laboratory Manager of any potential quality issues related to instruments and temperature-controlled laboratory units and provide recommendations for quality improvement.
Assist in implementing corrective actions related to audit findings concerning instrument validations.
Coordinate instrument calibration and maintenance, manage spare parts inventory, and liaise with vendors.
Advanced knowledge of maintenance management via SAP to collect information on calibrations and preventive maintenance.

B.Sc. (preferred) in biochemistry, physics, or a life sciences field.
At least six years of experience in the same role within a quality control laboratory in a cGMP environment in the pharmaceutical or biotechnology industry.
Strong communication, interpersonal, organizational, and decision-making skills.
Strong technical writing skills.
Advanced knowledge and skills for computerized systems used with laboratory equipment.
Knowledge of GMP and pharmacopoeias (USP, BP, EP) to support products for the Canadian, US and European markets.
Advanced knowledge of qualification of computerized analytical systems, data integrity requirements, and computer system validation for laboratory system applications.
Proficiency in MS Office (Excel, Word and PowerPoint) and strong experience with software/systems related to pharmaceutical applications.
Bilingual in French and English preferred (proficiency in English is required to handle documentation and communications with other Grifols sites outside Quebec and Canada (Spain, USA)).