Assistant Ii

3 months ago

Charlottetown, Canada Merck Sharp & Dohme Full time

The **_Assistant II - Quality Control Analyst_** is responsible for performing Work in Process (WIP) testing of all antigens, and batch release testing in accordance with approved Outlines of Production and Good Manufacturing Practices (GMP). In addition, the Quality Control technician is responsible for stability testing, environmental and utility testing, and qualification/validation activities as required.

**Functions, Duties, Tasks**:

- Performing all Work in progress (WIP) and Final Product batch release tests within the scope of the Outlines of Production, according to Good Manufacturing Practices principles.
- Methods include, but are not limited to microbiology, cell culture, and molecular biology techniques.
- Performing Environmental Monitoring (EM) tests and utilities testing for all departments.
- Performing Stability testing.
- Assisting in validation work as required.
- Equipment validations.
- Method validations.
- Update, maintain, create relevant Standard Operating Procedures, and forms.
- Recognize and report any Out of Specification (OOS) or deviations to Quality Control Manager.
- Initiate and complete investigations where applicable.
- Interactions with production departments to ensure results are communicated.
- Occasional after-hours work, and on-call schedule.
- Ability to work within all Quality systems.
- Cleaning duties.
- Maintaining inventory of reagents and expiry checks of materials.
- Other duties as required.

**Minimum Qualifications (education, experience and/or training, required certifications)**:

- Minimum Technical Diploma in Biotech or Lab technologist; Bachelor of Science is an asset.
- Minimum 2 years lab experience, Good Manufacturing Practices (GMP) training
- Must be available to work a schedule of 5 days/week. This includes one day in the weekend (i.e. from Tuesday to Saturday)

**Additional Preferences**:

- Advanced analytical and time management skills
- Excellent problem-solving skills.
- Communications and decision-making skills

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

**Secondary** Language(s) Job Description**:
**_ L' assistant II - Analyste en contrôle de la qualité_** est responsable de réaliser les tests en cours de traitement (WIP) de tous les antigènes, et les tests de libération par lot conformément aux Schémas de production approuvés et aux Bonnes pratiques de fabrication. De plus, le technicien en contrôle de la qualité est chargé des tests de stabilité, des tests environnementaux et utilitaires, ainsi que des activités de qualification/validation selon les besoins.

**Fonctions, tâches, missions**:

- Réaliser tous les tests en cours de traitement (WIP) et de libération des produits finis dans le cadre des Schémas de production, selon les principes des Bonnes pratiques de fabrication.
- Les méthodes comprennent, sans s'y limiter, des techniques de microbiologie, de culture cellulaire et de biologie moléculaire.
- Réaliser les tests de suivis environnementaux et les tests utilitaires pour tous les départements.
- Réaliser les tests de stabilité. Participer aux travaux de validation selon les besoins. Validations d'équipement.
- Validations de méthode.
- Mise à jour, maintenance, création de Procédures opératoires normalisées et formulaires pertinents.
- Reconnaître et signaler tout résultat hors spécifications (OOS) ou toute déviation au responsable Assurance Qualité.
- Initier et mener à bien les investigations si nécessaire. Interactions avec les départements de production pour assurer la communication des résultats.
- Travail occasionnel en dehors des heures de travail et horaires de permanence.
- Capacité à travailler dans tous les systèmes de qualité.
- Tâches de nettoyage. Maintien de l'inventaire des réactifs et vérification des dates de péremption des matériaux.
- Autres tâches selon les besoins.

**Qualifications mínimale (éducation, expérience et/ou formation, certifications requises)**:

- Diplôme technique minimum (biotechnologie ou technologue de laboratoire); baccalauréat en sciences est un atout.
- Minimum 2 ans d'expérience en laboratoire, formation en Bonnes pratiques de fabrication.
- Doit être disponible à travailler un horaire de 5 jours par semaine dont un jour le week-end (ex. du mardi au samedi)

**Préférences supplémentaires**:

- Compétences avancées en analyse et en gestion du temps Excellentes capacités de résolution de problèmes.
- Compétences en communication et prise de décision.

Nous sommes fiers d'être une entreprise qui embrasse la valeur de rassembler des

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