Assistant II - Quality Control Analyst

at  Merck Canada inc

Job Description
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.

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.

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)