Careers

Quality Assurance Specialist

Summary
Reporting to the Higher Manager, the QA Manager’s key role is to ensure the integrity of the ImmuniT’s Quality Management System (QMS) and ensures that the entire team are following the Canadian Food and Drugs Regulations. This function maintains quality compliance with Good Laboratory Practices (GLP), Good Clinical Practices (GCP) and Immuni T Standard Operating Procedures (SOPs).
Primary Duties and Responsibilities

  • Responsible for overseeing, planning and performing GLP/GCP compliance activities. Conduct documented study-, process-, and facility-based inspections to verify compliance to FDA Good Laboratory Practice for Nonclinical Laboratory Studies (21 CFR Part 58) (FDA GLP), OECD Principles of Good Laboratory Practice (OECD GLP), ICH Guideline for Good Clinical Practice (ICH E6(R2)) (GCP)

  • Develop and deliver training on FDA GLP, OECD GLP, GCP regulations to the entire team

  • Lead quality accreditation and recognition initiatives for the company

  • Maintain company’s Standards Council of Canada recognition of compliance with OECD GLP

  • Host external inspections by sponsors, accrediting or certifying bodies, and regulatory agencies

  • Development and Maintenance of existing SOPs and writing new SOPs. Publish and control the standards, regulations and laws.

  • Maintain the list of SOPs and control the assignment of SOP, FRM, TEM codes.

  • Vendor/Supplier Audits

  • Validation of Computer Systems implemented at Immuni T 

  • Provide, develop, source and coordinate ongoing regulatory and compliance presentations and associated training to the entire team to ensure that all colleagues understand and comply with FDA GLP, OECD GLP, GCP regulations and guidlines

  • Lead system validation studies and ensure that system validations are planned, conducted, and reported in compliance with the applicable standard operating procedures, policies, standards, regulations and laws

  • Work with process owners, system owners, users, and management

  • Ensure that validated systems maintain their validated state and Submit system validation documentation for archiving promptly to ensure that the documentation is protected from loss and untimely deterioration

  • Ensure data generated by validated systems is available for review throughout the required
    retention period for the material

  • Ensures that archive facilities and archived materials operate in compliance with the applicable
    standard operating procedures, policies, standards, regulations, and laws

  • Controls access to archived materials. Controls and documents the movement of materials in
    and out of the archives. Manages off-site archiving service providers, including ensuring that the
    providers meet their obligations under the applicable contract and / or service level agreement.

Preferred Qualifications

  • B.Sc. or M.Sc. or Ph.D., with at least 5-7 years of experience in Quality Assurance

  • In-depth experience with FDA GLP, OECD GLP, GCP as applied to the audit of bioanalytical facilities

  • Experience hosting inspections by sponsors, accrediting or certifying bodies, and regulatory agencies

  • Familiarity with principles of operation of common bioanalytical equipment and instruments

  • Experience with Ligand Binding Assays (LBA) and Flowcytometry techniques is a must

  • Experience developing and evaluating corrections, corrective actions, and preventative actions in response to deviations or inspection observations

  • Experience working with LibreOffice Writer and Calc, including using and configuring paragraph, character, and page styles

  • Exceptional organizational skills and strong attention to detail

  • Demonstrated prioritization skills and ability to multi-task to meet tight deadlines

  • Proven analytical and problem-solving skills

  • Able to work cross-functionally with business partners

  • Proven ability to lead strong teams and mentor staff

  • Experience applying FDA Electronic Records; Electronic Signatures (21 CFR Part 11) and FDA Guidance for Industry: Part 11, Electronic Records; Electronic Signatures – Scope and Application to computerized system validation.

  • Knowledge of ISPE GAMP 5 is an asset

  • Excellent communication skills in both English and French with English written and spoken fluency.

Analyste médical

Les rôles et responsabilités

L’analyste médical est responsable du traitement des spécimens biologiques pour fins de diagnostic dans le laboratoire d’hématologie. Il s’assure de l’intégrité des échantillons en suivant les normes et procédures établies :

 

  • Effectuer les analyses des échantillons biologiques;

  • Vérifier l’intégrité des spécimens afin d’en assurer une bonne gestion;

  • Assurer la qualité des résultats en appliquant les différentes procédures normatives en vigueur;

  • Toute autre tâche connexe requise par les fonctions du poste.

Lieu et horaire de travail

  • Immuni T est localisée dans le sympathique Quartier des spectacles avec un accès direct au Métro Place des arts, au complexe Desjardins et aux boutiques de la rue Sainte-Catherine.

  • Siège social :

    Immuni T

5ème étage, bureau SB-5180 141 Avenue Président-Kennedy Montréal QC, H2X 1Y4 514 545 3097 UQAM campus et Quartier des spectacles. (Métro place des Arts)

  • Horaire de travail

    Lundi au vendredi : 8h30 à 17h00 

Le profil recherché

  • Diplôme d’études collégiales en technologie d’analyses biomédicales ou technique de laboratoire médical;

  • Être membre de OPTMQ

  • Expérience pertinente en Immunologie et hématologie, un atout important;

  • Maîtrise des logiciels de la suite Microsoft Office;

  • Détenir un haut niveau d’autonomie;

  • Être orienté vers le service à la clientèle.

  • Contrôle de qualité

  • Assure l'entretien préventif des appareils et la désinfection des surfaces de travail selon les procédures établies.

  • Applique les procédures de contrôle de qualité des équipements et avise le coordonnateur du laboratoire en cas d’anomalies.

  • Conserve les échantillons et les requêtes selon les procédures établies.

  • Procède à l’élimination des échantillons, des requêtes et des déchets biomédicaux selon les procédures.

  • Transmet les résultats d’analyses selon les procédures, en respectant les normes de confidentialité.

Qualités personnelles et professionnelles
• Esprit d’équipe et collaboration;
• Communications interpersonnelles et organisationnelles;
• Autonomie et rigueur;
• Analyse et résolution de problème;
• Crédibilité;
• Sens de l’organisation;
• Habiletés à gérer la charge du travail.

 

Type d'emploi : Temps complet

Langue:

  • Française (Requis)

  • Anglaise (Souhaité)

Analyst


Main Responsibilities


The role of an Analyst at Immuni T is to develop and implement classical and novel approaches for cell-based and non-cell
based assays using flow cytometry, ELISpot. ELISA, MSD orLUMINEX platforms for example. He/she, has responsibility
to serve as a technical resource and bench analyst in the lab. The Analyst will work to establish Standard Operating
Procedures (SOPs) under Good Laboratory Practices (GLP). She/He is expected to understand and have hands-on expertise
in standardization, validation and samples analysis for pre-clinical and clinical studies. Other responsibilities are, but not
limited to:
1. To carry out cell culture of primary immune cells, or cell lines, for the purpose of conducting cellular phenotyping
and functional assays;
2. To be able to use technology transferred assays (method transfers) sent by client sites and thus support cross-site
standardization of analytical methods;
3. Maintain proper documentation of all research activities in compliance with the relevant Standard Operating
Procedures (SOPs), policies, and applicable regulations;
4. To demonstrate continuous integrity and credibility;
5. To develop new assays using various platforms including novel cell culture systems, ELISA, ELISpot, Luminex,
MSD, Flow cytometry;
6. To be able to document procedures execution, deviations, troubleshooting activities if needed;
7. To perform in-depth data analysis for each experiment and prepare data analysis packages, including text, tables and
figures;
8. To present data and work procedures internally to the team, and externally to the clients;
9. To be able to team work and communicate effectively with other team members and responsible managers;


Qualifications:


1. Dec or B. Sc. in immunology, cell biology, molecular biology, or a related discipline;
2. A minimum 5 years experience in a biotech/pharma or CRO companies;
3. Hands-on experience in designing multicolor flow cytometry panels (up to few dozen color panels), cell
purification and enrichment schemes (magnetic beads enrichment for example), qPCR, ELISA, multiplexed
Luminex assays, multiplex in vitro cytotoxicity assays and other applicable techniques;
4.Knowledge of non-flow cell-based assays to monitor innate and adaptative molecular and cellular response
patterns;
5.Excellent time management and good organizational skills and the ability to work effectively in a high paced, fast
changing environment, on multiple projects through their ability to manage multiple and varied tasks with
enthusiasm and prioritize workload with attention to detail;
6. Strong troubleshooting skills;
7. Able to work effectively independently as well as in a team;
8. Knowledge and understanding of GLP, GCLP, regulations and other regulatory guidelines;
9. Must be willing to perform duties in Bio Safety Level 2 (BSL-2) facilities;
10. Excellent written and oral communications skills (English and French).

Scientist

Main Responsibilities


The role of a Scientist at Immuni T is to develop, validate and implement novel approaches for cell-based and non-cell
based assays in Immunology using flow cytometry, ELISpot. ELISA, MSD or LUMINEX platforms. He/she, has
responsibility to serve as a scientific and technical resource to the study directors and the bench analysts. The Scientist will
work to establish and maintain, with the team, Standard Operating Procedures (SOPs) under Good Laboratory Practices
(GLP). She/He is expected to understand and have hands-on expertise in standardization, development, validation and
samples analysis for discovery, development, pre-clinical and clinical studies. Other responsibilities include but are not
limited to:
1. Set up and execute cell-based and in-vitro assays to assess the potential efficacy and safety of lead product
candidates.
2. Carry out cell culture of primary immune cells or cell lines for the purpose of conducting cellular phenotyping and
functional assays;
3. Lead technology transfer of assays to or from client sites and support cross-site standardization of analytical
methods;
4. Support efforts to establish and maintain policies and procedures related to lab operations and biosafety.
5. Maintain electronic laboratory notebooks for proper documentation of all research activities in compliance with the
relevant Standard Operating Procedures (SOPs), policies, and applicable regulations;
6. Ensure all projects assigned to him/her are performed on a timely basis, in a compliant manner and delivered with
maximum impact, within specified budgets;
7. Deliver reports, summaries, and presentations supporting experimental results;
8. Demonstrate continuous integrity, credibility, positivity and motivational behaviour;
9. Develop new assays using various platforms including ELISA, ELISpot, Luminex, MSD and Flow cytometry;
10. Communicate with team members, upper managements and clients proactively;
11. Design, execute and document troubleshooting activities;
12. Interpret data in a scientific and professional manner and present it internally to the team, and externally to the
clients.


Qualifications:


1. M. Sc. or Ph.D. in immunology or equivalent experience in immunology using cell biology and molecular biology
as tools;
2.A minimum 5 years experience in a biotech/pharma or CRO companies with experience developing, qualifying and
validating assays for therapeutic programs;
3.Knowledge and understanding of GLP, GCLP regulations and other relevant regulatory guidelines;4.
Hands-on experience in designing multicolor flow cytometry panels (up to few dozen color panels), cell culture,
cell purification and enrichment schemes (magnetic beads enrichment for example), qPCR, ELISA, ELISpot ,
multiplexed Luminex assays for multiplexed in vitro cytotoxicity techniques;
5.Knowledge of non-flow cell-based assays to monitor innate and adaptative molecular and cellular response
patterns;
6. Able to keep confidentiality of projects and possess high level of integrity;
7. Excellent time management and good organizational skills and the ability to work effectively in a high paced, fast
changing environment, on multiple projects through their ability to manage multiple and varied tasks with
enthusiasm and prioritize workload with attention to detail;
8. Able to manage multiple and varied tasks with enthusiasm and prioritize workload with attention to detail.
9. Strong troubleshooting skills;
10. Able to work independently and in a team;
11. Must be willing to perform duties or supervise activities in Bio Safety Level 2 (BSL-2) facilities;
12. Communicates clearly and confidently and has excellent interpersonal and teaching skills;
13. Excellent written and oral communications skills (English and French)

We are constantly seeking researchers, laboratory staff and programmers or bioinformaticians who reach well beyond standards. Please send your CV to  emplois@immunit.com

Visit regularly our website and our Linkedin page for open positions.