Biochemist with 7 years of experience in biopharmaceutical development, mainly in preclinical studies and quality assurance. I have a strong knowledge of Good Manufacturing Practices (GMP) and related regulatory requirements. Passionate about data science, I learn quickly and enjoy a fast-paced, problem-solving work environment. Recognized for my teamwork and my proactive approach, I have good communication and organizational skills as well as an excellent work ethic.
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Senior Quality SpecialistLinearis Oct 2023 - PresentQuébec, Canada• Contribute to the establishment of a quality system that meets regulatory and commercial standards.• Contribute to the establishment of a certified high-throughput metabolomics/artificial intelligence service laboratory by working in close collaboration with the research and development team. -
Research Associate - Preclinical StudiesMedicago Sep 2017 - Jun 2023Québec, Canada• Responsible for the operational conduct of preclinical studies which includes:Material planning and tracking, shipments of material and samples, drafting and reviewing documents, tracking study timelines and study closeout activities.• Coordination of analysis activities.• Perform this role in accordance with applicable regulatory component, including: Good Manufacturing Practices (GMP), Good Documentation Practices (GDP) and Good Laboratory Practices (GLP).• Establish and maintain a continuous collaboration with internal and external stakeholders. • Develop different tools to improve team efficacy.• Provide support for data management.• Participate in budget exercises and carry out budget monitoring.
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Specialist - Quality AssuranceMedicago Jan 2016 - Sep 2017Quebec, Canada• Implementation of an Electronic Quality Management System (eQMS) via:Platform configuration, user roles and access management, training users on the platform and support to other departments with eQMS.• Perform data management to monitor and react to quality systems performance via metrics.• Provide operational support to other departments in good documentation practices, data integrity compliance and site inspection readiness.• Perform internal audits and other compliance programs as required.• Coordinate storage and retrieval with external document storage provider.
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Continuous Improvement Coordinator Iso 9001: 2008 / Customer, Technical And Supply ServicesLaboratoire Mat Inc. Nov 2010 - Jan 2016
Marie-Lou Audet Education Details
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Biochimie -
Biochemistry
Frequently Asked Questions about Marie-Lou Audet
What company does Marie-Lou Audet work for?
Marie-Lou Audet works for Linearis
What is Marie-Lou Audet's role at the current company?
Marie-Lou Audet's current role is Biochemist - Senior Quality Specialist.
What schools did Marie-Lou Audet attend?
Marie-Lou Audet attended Université Laval, Université Laval.
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Marie-Lou Audet
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