Reviewer Quality Control, Validation and

6 days ago

Laval, Canada IQVIA Full time

Dotés d’une expertise inégalée en immunologie et présents en Amérique du Nord (côte Est et Ouest) et en Europe, Nexelis est l’un des principaux prestataires de services dans le domaine du développement et l’analyse de tests biologiques spécialisés en infectiologie, métabolisme, et cancérologie. Notre équipe polyvalente de scientifiques, munie de plateformes technologiques à la fine pointe du progrès a joué un rôle essentiel dans le développement, la qualification, validation de tests et leur utilisation en haut débit dans plus de 100 dossiers associés à l’approbation par la FDA de nouvelles entités moléculaires, comprenant des vaccins majeurs, des antiviraux et des produits d’immunothérapie, de thérapie génique ou cellulaire.

**Vos principales responsabilités**:

- Effectuer le contrôle de la qualité des instruments de laboratoire et la maintenance et calibration de facon electronique ou en papier
- Effectuer le contrôle de la qualité et la vérification des données entrées dans le Système de gestion des informations de laboratoire (LIMS)
- Participer à l’amélioration du processus de révision des données
- Participer à la rédaction de rapports pour l'Équipe de vali

**Ce que nous recherchons**:

- Minimum de 3 ans d'expérience en control qualité et dans a révision de données dans un environnement réglementé tel qu’un CRO
- Être familier avec les BPL et les BPC
- DEC ou Baccalauréat en sciences biologiques, ingénierie ou autre.
- Être à l'aise dans les environnements à forte croissance
- Connaissance des principaux logiciels de la suite MS Office
- Excellent français et anglais, écrit et parlé

Job Overview
The QC Inspector I applies quality control experience and extensive knowledge of process review into practical quality solutions for the organization. The Sr. QC Inspector evaluates, monitors, and systematically recommends corrective actions of procedures and processes. Professionally conducts reviews with a high level of communication that yields quality results.

**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 with at least 3 years’ relevant experience in a quality / laboratory environment, including GXP and/or Quality Assurance experience or equivalent combination of education, training and experience.
- Laboratory experience in a GLP environment.
- Knowledge of GLP regulations and guidelines and basic auditing techniques.
- Strong interpersonal skills and 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.

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