QC Technician
Fermé
Position Description: The Quality Control Technician is responsible for performing Work in Process (WIP) testing of all antigens, and batch release testing in accordance with approved Outlines of Production and GMP. In addition, the QC technician is responsible for stability testing, environmental and utility testing, and qualification / validation activities as required.
Functions, Duties, Task:
Testing:
Performing all WIP and Final Product batch release tests within the scope of the Outlines of Production, according to GMP principles.
Methods include, but are not limited to microbiology, cell culture, and molecular biology techniques
Performing 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 SOPs, SOs, MDFs and forms
QC Department Support:
Recognize and report any OOS or deviations to QC 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 (including Trackwise, Regulus, Sharepoint)
Cleaning duties
Maintaining inventory of reagents and expiry checks of materials
Additional duties as required.
Minimum Qualification (education, experience and/or training, required certifications):
Education:
Minimum B.Science or Technical Diploma (Biotech or Lab technologist)
Experience:
Minimum 2 years lab experience, GMP training
Additional Preferences:
Advanced analytical and time management skills
Excellent problem solving skills
Communications and decision making skills
