Job Description

Dot\xc3\xa9s d\xe2\x80\x99une expertise in\xc3\xa9gal\xc3\xa9e en immunologie et pr\xc3\xa9sents en Am\xc3\xa9rique du Nord (c\xc3\xb4te Est et Ouest) et en Europe, Nexelis est l\xe2\x80\x99un des principaux prestataires de services dans le domaine du d\xc3\xa9veloppement et l\xe2\x80\x99analyse de tests biologiques sp\xc3\xa9cialis\xc3\xa9s en infectiologie, m\xc3\xa9tabolisme, et canc\xc3\xa9rologie. Notre \xc3\xa9quipe polyvalente de scientifiques, munie de plateformes technologiques \xc3\xa0 la fine pointe du progr\xc3\xa8s a jou\xc3\xa9 un r\xc3\xb4le essentiel dans le d\xc3\xa9veloppement, la qualification, validation de tests et leur utilisation en haut d\xc3\xa9bit dans plus de 100 dossiers associ\xc3\xa9s \xc3\xa0 l\xe2\x80\x99approbation par la FDA de nouvelles entit\xc3\xa9s mol\xc3\xa9culaires, comprenant des vaccins majeurs, des antiviraux et des produits d\xe2\x80\x99immunoth\xc3\xa9rapie, de th\xc3\xa9rapie g\xc3\xa9nique ou cellulaire. Nexelis, une entreprise de Q2 Solutions, continue sa croissance et nous sommes pr\xc3\xa9sentement \xc3\xa0 la recherche d\xe2\x80\x99un (e) candidat(e) motiv\xc3\xa9(e) pour occuper le poste de scientifique, virologie, d\xc3\xa9velopement de tests. vos principales responsabilit\xc3\xa9s :

• Effectuer le contr\xc3\xb4le de la qualit\xc3\xa9 des donn\xc3\xa9es de laboratoire et r\xc3\xa9viser l\xe2\x80\x99entr\xc3\xa9e de celles-ci
• Effectuer le contr\xc3\xb4le de la qualit\xc3\xa9 et la v\xc3\xa9rification des donn\xc3\xa9es entr\xc3\xa9es dans le Syst\xc3\xa8me de gestion des informations de laboratoire (LIMS)
• Participer \xc3\xa0 l\xe2\x80\x99am\xc3\xa9lioration du processus de r\xc3\xa9vision des donn\xc3\xa9es
• Participer \xc3\xa0 la r\xc3\xa9daction de rapports

Ce que nous recherchons :

• Minimum de 3 ans d\'exp\xc3\xa9rience dans la r\xc3\xa9vision de donn\xc3\xa9es et dans un environnement r\xc3\xa9glement\xc3\xa9 tel qu\xe2\x80\x99un CRO
• \xc3\x8atre familier avec les BPL et les BPC
• DEC ou Baccalaur\xc3\xa9at en sciences biologiques
• \xc3\x8atre \xc3\xa0 l\'aise dans les environnements \xc3\xa0 forte croissance
• Connaissance des principaux logiciels de la suite MS Office
• Connaissances suffisantes de l\xe2\x80\x99anglais \xc3\xa9crit et parl\xc3\xa9 afin d\xe2\x80\x99\xc3\xaatre en mesure de bien comprendre les documents servant \xc3\xa0 l\xe2\x80\x99ex\xc3\xa9cution du travail et d\xe2\x80\x99interagir avec nos clients majoritairement anglophones

Nexelis, a Q2 solutions company keeps growing and we are looking for an enthusiastic Scientists to join our R&D Virology team. At Nexelis you will have the chance to participate in the daily life of the most successful advanced testing service provider in the immunology field. Involved in more than 15 SARS-CoV-2 vaccine developments in partnership with multinational pharmaceutical companies, innovative biotechnology companies and prestigious NGOs such as Bill and Melinda Gates Foundation or CEPI, we also proudly serve the needs of our clients in fields such as Flu (universal and seasonal), meningitis, respiratory syncytial virus, chikungunya, malaria, or HPV and are growing an immune-oncology franchise.
Your main responsibilities:

• Provide Quality Control (QC) support to operations.
• Perform QC review of Sample Login binders, Bioanalytical run binders, Wet Lab notebooks, data tables, data table summaries and electronic submissions.
• Participate in review and development of technical and QC SOPs to ensure compliance with appropriate regulations.
• Actively participate in QC educational programs: in-house workshops, presentations on current QC issues, QC training and QC Seminars for all new employees, etc.
• Lead or assist director in leading QC and staff meetings and discuss findings and recommendations for resolving non-compliance.
• Work closely with operation individuals to improve quality systems.
• Manage and schedule all assigned quality control projects with minor assistance from coworkers and manager.
• Communicates progress and strategic planning to the Director of Quality Assurance, or designee, in clear and concise appraisal with recommendations.
• Track and report deviation trends to management.
• Utilize root cause analysis to evaluate all systems for gaps, recommend action and professionally communicate to management the analysis to continually improve quality.
• Design, develop and implement new QC procedures.
• Demonstrate continuous self-motivated quality development.
• Proactively take steps to improve quality systems.

What we are looking for:

• Bachelor\'s Degree in relevant scientific discipline such as Chemistry, Biochemistry, Immunology.
• 3 years\xe2\x80\x99 relevant experience in a quality / laboratory environment, including GXP and/or Quality Assurance experience or equivalent combination of education, training and experience required.

• Experience in a CRO will be considered an asset.
• Bilingual, English and French is required since daily interaction happens in French.
• Laboratory experience in a GXP environment.
• Knowledge of word-processing, spreadsheet, and database applications.
• Knowledge of GXP regulations and guidelines and basic auditing techniques.
• Strong interpersonal skills.
• Excellent problem solving skills.
• Effective organization, communication, and team orientation skills.
• Ability to initiate assigned tasks and to work independently.
• Ability to manage multiple projects.
• Ability to establish and maintain effective working relationships with coworkers, managers and clients.

Q\xc2\xb2 Solutions is a leading clinical trial laboratory services organization with end-to-end laboratory services and secure, enterprise-wide biospecimen and consent management solutions. https://q2labsolutions.com/careers