Job Summary (Primary function)
During the construction and QC laboratory startup phase, the QC technician will participate to equipment setting up and order the material and reagent needed for the Lab.
The QC technician will be the author of the analytical procedures and also the general QC procedures, like standard management, equipment usage, and/or sampling.
This role will be responsible to sample and perform the analyses linked to production area qualification, utilities qualification and raw material testing.
During manufacturing operation, the QC technician will perform the QC analysis to support production and release of drug substance. The team will be multi-purpose and the QC technician will need to perform a large panel of analyses.
Essential Functions of the Job (Key responsibilities)
During the construction phase, you will mainly:
• Author and maintain comprehensive work instructions
• Actively participate in regular calls, status updates with process equipment manufacturers in order to ensure that the delivery will be on the agreed timeline
• Initiate deviations including any corrective actions arising during verifications
• Propose and initiate Change requests when needed
• Prepare and deliver training to new members of the team
• Order the material and reagents that are needed for QC activities
• Participate in the test method tech transfer
During the operational phase, you will mainly:
• Perform the QC analysis to support production and release of drug substance and perform a large panel of analyses
• Author, review and maintain (lifecycle etc.) of all required Standard Operating Procedures, Work Instructions, and other quality documents related to areas of responsibility, as well as support other areas as required
• Act as a mentor to more junior team members and lead by example to ensure timely analyses with the appropriate quality level
• Proactively propose problem resolutions
• Raise, investigate and close events, deviations and non-conformances
• Raise and define action for the Change Controls
• Contribute positively to a strong culture of business integrity and ethics
• Act within compliance and legal requirements as well as within company guidelines
Qualifications (Minimal acceptable level of education, work experience, and competency)
• CFC or BTS with at least 5 years’ experience in the biotech, pharmaceutical or chemical environment
• Hands-on experience in a GMP environnement
• Follow the security rules required to work in a laboratory
• Ability to work in a fast paced – high regulated environment
• French with a good level in English
• Team work oriented mindset
• Shift work is expected
Disclaimer: The above statements are intended to describe the general nature and level of work performed by employees assigned to this job. They are not intended to be an exhaustive list of all duties, responsibilities, and qualifications. Management reserves the right to change or modify such duties as required.