Job Description

\xc3\x80 propos de CellCarta

CellCarta est l\'un des principaux fournisseurs \xc3\xa0 l\'industrie biopharmaceutique en mati\xc3\xa8re de services de laboratoire sp\xc3\xa9cialis\xc3\xa9s en m\xc3\xa9decine de pr\xc3\xa9cision. Gr\xc3\xa2ce \xc3\xa0 ses plateformes analytiques int\xc3\xa9gr\xc3\xa9es en immunologie, histopathologie, prot\xc3\xa9omique et g\xc3\xa9nomique, ainsi qu\'\xc3\xa0 ses services connexes de collecte d\'\xc3\xa9chantillons et de logistique, CellCarta soutient l\'ensemble du cycle de d\xc3\xa9veloppement des m\xc3\xa9dicaments, de la d\xc3\xa9couverte aux essais cliniques avanc\xc3\xa9s. La compagnie est pr\xc3\xa9sente dans le monde entier et emploie plus de 1,000 personnes dans ses neuf sites situ\xc3\xa9s au Canada, aux \xc3\x89tats-Unis, en Belgique, en Australie et en Chine.

R\xc3\xa9sum\xc3\xa9 du poste

Relevant du directeur de l\'assurance qualit\xc3\xa9, l\'associ\xc3\xa9(e) assurance qualit\xc3\xa9 (AQ) est charg\xc3\xa9(e) de mener des audits et des r\xc3\xa9visions de l\'assurance qualit\xc3\xa9 et de pr\xc3\xa9senter des rapports \xc3\xa0 ce sujet. L\'associ\xc3\xa9 AQ soutient le d\xc3\xa9partement AQ dans l\'\xc3\xa9valuation de la conformit\xc3\xa9 des \xc3\xa9tudes cliniques et non cliniques avec les r\xc3\xa9glementations, les directives, les protocoles d\'\xc3\xa9tude, les plans d\'\xc3\xa9tude et les proc\xc3\xa9dures op\xc3\xa9rationnelles standard (SOP) de l\'entreprise.

Principales responsabilit\xc3\xa9s

• Effectuer des audits des installations et des \xc3\xa9tudes de l\'entreprise pour v\xc3\xa9rifier la conformit\xc3\xa9 aux bonnes pratiques cliniques (BPC), aux bonnes pratiques de laboratoire (BPL), aux proc\xc3\xa9dures op\xc3\xa9rationnelles standard (SOP), aux protocoles d\'\xc3\xa9tude, aux r\xc3\xa9glementations et aux directives pertinentes (FDA, Sant\xc3\xa9 Canada, EMEA, etc.) ;
• Effectuer des inspections d\'\xc3\xa9tudes bioanalytiques, pour v\xc3\xa9rifier la conformit\xc3\xa9 aux principes de bonnes pratiques de laboratoire de l\'OCDE, aux plans d\'\xc3\xa9tude et aux proc\xc3\xa9dures op\xc3\xa9rationnelles standard (SOP) lors des phases critiques des \xc3\xa9tudes ;
• Examiner les plans de travail, les plans d\'\xc3\xa9tude, les CAPA, les contr\xc3\xb4les des changements/impl\xc3\xa9mentations, les SOP ;
• V\xc3\xa9rifier la documentation pr\xc3\xa9alable \xc3\xa0 l\'\xc3\xa9tude, les activit\xc3\xa9s en cours de traitement, la documentation de fin d\'\xc3\xa9tude et les rapports d\'\xc3\xa9tude ;
• Effectuer diverses v\xc3\xa9rifications de l\xe2\x80\x99installation, y compris des v\xc3\xa9rifications de l\xe2\x80\x99entretien de l\xe2\x80\x99\xc3\xa9quipement, des dossiers de formation, de la validation informatique et de la qualification des fournisseurs ;
• Tenir la direction au courant des constatations et faire le suivi des mesures correctives ;
• Aider \xc3\xa0 la r\xc3\xa9vision, \xc3\xa0 la r\xc3\xa9daction et \xc3\xa0 la distribution des SOP, s\xe2\x80\x99il y a lieu ;
• Aider la direction de l\'AQ \xc3\xa0 accueillir les audits/inspections des sponsors et des autorit\xc3\xa9s r\xc3\xa9glementaires ;
• Assister le d\xc3\xa9partement AQ dans la formation du personnel sur les SOP et les BPC/BPL.
• Coordonner et collaborer avec d\'autres d\xc3\xa9partements pour s\'assurer que les objectifs de l\'entreprise, du d\xc3\xa9partement et de l\'\xc3\xa9tude sont atteints.

Formation
*BSc en sciences de la vie, ou \xc3\xa9quivalent.

Exigences principales

• 1 \xc3\xa0 2 ans d\'exp\xc3\xa9rience en QC/QA, ou dans un domaine connexe, comprenant de pr\xc3\xa9f\xc3\xa9rence des audits d\'\xc3\xa9tudes dans un environnement r\xc3\xa9glementaire (BPL de pr\xc3\xa9f\xc3\xa9rence) ;
• Connaissance et compr\xc3\xa9hension des BPC, de l\'EMA, de l\'OCDE, de l\'ICH, de la FDA en relation avec les bonnes pratiques de laboratoire (BPL) et/ou les exigences de qualit\xc3\xa9 des BPC/BPL ;
• Exp\xc3\xa9rience de la r\xc3\xa9daction et de la r\xc3\xa9vision de proc\xc3\xa9dures op\xc3\xa9rationnelles standard (SOP) ;
• Communication \xc3\xa9crite et verbale claire et concise en anglais ;
• Connaissance du d\xc3\xa9veloppement des m\xc3\xa9dicaments, de la validation des m\xc3\xa9thodes analytiques, de l\'assurance qualit\xc3\xa9 et de la conformit\xc3\xa9 r\xc3\xa9glementaire ;
• Diverses techniques de bioanalyse, un atout (p. ex. immuno-essais, quantification, spectrom\xc3\xa9trie de masse, etc ;)
• Haut niveau d\'attention aux d\xc3\xa9tails et \xc3\xa0 la pr\xc3\xa9cision, excellentes techniques d\'investigation ;
• Un engagement fort et de la motivation personnelle ;
• Excellent sens de l\'organisation ;
• Flexibilit\xc3\xa9 av\xc3\xa9r\xc3\xa9e pour s\'adapter \xc3\xa0 des priorit\xc3\xa9s en constante \xc3\xa9volution, g\xc3\xa9rer des t\xc3\xa2ches multiples, tout en maintenant la qualit\xc3\xa9 ;
• Capacit\xc3\xa9 \xc3\xa0 bien travailler dans un environnement d\'\xc3\xa9quipe ;
• Capacit\xc3\xa9 \xc3\xa0 identifier et/ou r\xc3\xa9soudre les probl\xc3\xa8mes de qualit\xc3\xa9, de mani\xc3\xa8re proactive, diplomatique, flexible et constructive ;
• Capacit\xc3\xa9 \xc3\xa0 concevoir et \xc3\xa0 mettre en \xc5\x93uvre des processus de qualit\xc3\xa9.

Conditions de travail

• Doit accepter d\'effectuer des t\xc3\xa2ches (par exemple, des inspections) dans des installations de niveau de bios\xc3\xa9curit\xc3\xa9 (BSL) 1 et 2 o\xc3\xb9 les \xc3\xa9chantillons biologiques peuvent \xc3\xaatre infect\xc3\xa9s naturellement ou exp\xc3\xa9rimentalement par des virus potentiellement dangereux tels que le VIH, le VHC ou le CMV ;
• L\'employ\xc3\xa9(e) doit respecter les mesures de s\xc3\xa9curit\xc3\xa9 de l\'entreprise dans l\'ex\xc3\xa9cution de son travail et suivre les proc\xc3\xa9dures op\xc3\xa9rationnelles standard en tout temps.

About CellCarta

CellCarta is a leading provider of specialized precision medicine laboratory services to the biopharmaceutical industry. Leveraging its integrated analytical platforms in immunology, histopathology, proteomics, and genomics, as well as related specimen collection and logistics services, CellCarta supports the entire drug development cycle, from discovery to late-stage clinical trials. The company operates globally with over 1,000 employees in its nine facilities located in Canada, USA, Belgium, Australia, and China.

Summary

Reporting to the Director of Quality Assurance, the Quality Assurance (QA) Associate is responsible for conducting and reporting quality assurance audits and reviews as scheduled. The QA Associate supports the QA department in assessing compliance of clinical and non-clinical studies with applicable regulations, guidelines, study protocols, study plans and company SOPs.

Responsibilities

• Perform audits of company facility and studies for compliance with Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Standard Operating Procedures (SOPs), study protocols, pertinent regulations and guidelines (FDA, Health Canada, EMEA, etc.);
• Perform inspections of Bioanalytical studies, for compliance with the OECD Principles of Good Laboratory Practices, Study Plans and Standard Operating Procedures (SOPs) at the critical phases of the studies;
• Review Workplans, Study plans, CAPAs, Change Controls/Implementations, SOPs;
• Audit pre-study documentation, in-process activities, end-of-study documentation and study reports;
• Conduct various facility audits, including audits of equipment maintenance, training records, computer validation and vendor qualification;
• Keep Management up to date with findings and follow up on corrective actions;
• Assist in the review, writing and distribution of SOPs, as applicable;
• Assist QA management in hosting sponsor and regulatory audits/inspections;
• Assist QA department in the training of personnel on SOPs and GCPs/GLPs.
• Coordinate and interact with other departments to ensure corporate, departmental and study goals are met.

Education

• BSc in life science, or equivalent.

Main Requirements

• 1-2 years QC/QA experience, or related field, preferably including audits of studies in a regulatory environment (GLP preferred);
• Knowledge and understanding of GCP, EMA, OECD, ICH, FDA in relation to Good Laboratory Practice (GLP) and/or GCP/GCLP quality requirements;
• Experience writing and reviewing Standard Operating Procedures (SOPs);
• Clear and concise written and verbal English communication;
• Knowledge in Drug Development, Validation of Analytical Methods, Quality Assurance and Regulatory Compliance;
• Various bioanalysis techniques an asset (e.g. Immunoassays, Quantitation, Mass Spectrometry, etc.);
• High level of attention to detail and accuracy, excellent investigative techniques;
• Strong commitment and self-motivated;
• Excellent organizational skills;
• Proven flexibility to adjust to constantly changing priorities, handle multiple tasks, while maintaining quality;
• Ability to work well in a team environment;
• Ability to identify and/or resolve quality issues, in a proactive, diplomatic, flexible and constructive manner;
• Ability to design and implement quality processes.

Working Conditions

• Must accept to perform duties (e.g. inspections) in Bio Safety Level (BSL) 1 and 2 facilities where biological samples may be either naturally or experimentally infected with potentially hazardous viruses such as HIV, HCV, or CMV;
• Employee is personally responsible for following Health and Safety guidelines/instructions.

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