North York, Ontario

Quality Assurance Associate II – mBPR

Quality Assurance Associate II
Full-time, North York
 
Reason: Data Integrity remediation project for regulatory compliance.
Duties:
Optimize and standardize mBPRs (seek opportunities to improve our recording of manufacturing data and apply these improvements to new mBPRs or during the maintenance/updating of existing ones, create and maintain the database of standard objects)
Support continuous improvement initiatives within manufacturing (support new initiatives and/or manufacturing facilities by providing guidance in data recording requirements, drive standardization of manufacturing methods across similar processes, coordinate and facilitate discussions in the development of mBPRs with all stake holders)
Implements Corrective and Preventative Actions in response to Deviations.
Initiate and manage change control requests.
Collaborate with assessors for evaluation of changes.
Ensure timely closure of change controls.      
Prepare and update GMP documents such as SOPs, SWIs, protocols, reports.
Efficiently use company tools such as SAP, TrackWise, QeDoc, etc. and the ability to adapt to new tools
 
Education:
A minimum of a B.Sc degree in Life Science-related field (e.g. Biology, Biochemistry, Biotechnology, Pharmacology, Chemical Engineering and Health Science).
4 – 6 year experience and understanding of manufacturing/testing environments in the pharmaceutical Biotech Industry, and computerized systems.