Microbix Biosystems is a fast growing biotechnology company based in Mississauga.
Founded in 1988 as a producer of infectious disease antigens, primarily for the diagnostics market, Microbix invests in the virology business to build capacity and develop new products to address emerging market opportunities, while enhancing manufacturing and laboratory capabilities and technologies.
Our emerging products take aim at large market opportunities. With Microbix' core competencies in the Diagnostics business, including cell culture, molecular biology, and GMP quality system, these new products build on Microbix' strength.
We are currently hiring for the following positions:
Microbix is seeking an experienced QA professional who is committed to ensuring completeness and accuracy in Quality Management System (QMS) processes and documentation. Reporting to the Director of QA and Compliance, a QA Associate will work in QA department to support various activities related to the upkeep of our ISO 9001 and 13485 QMS processes. Ideally, a detail oriented and analytical worker with a strong ability to use good judgment with multiple priorities, the successful candidate should have experience at establishing and enhancing SOP’s, coordinating input from multiple departments, and influencing internal departments on compliance issues.
• Ensure the accuracy and completeness of all quality records, including nonconformance records, complaint resolutions, change requests, CAPA’s, etc.
• Maintain a complete filing system for all documentation
• Maintain an up-to-date list of approved standard operating procedures, production documents and protocols. Distribute approved procedures for use. Keep register of all distributed procedures to ensure retrieval of revised or obsolete documents.
• Assemble batch production records. Review batch production records for completion and accuracy. Execution of final product release prior to shipment. This involves ensuring that all documentation is correct and proper labeling has occurred.
• Create and maintain certificate templates, create certificates as needed for batch release and send to appropriate parties, as required.
• Review SOP’s for compliance with current practices, regulatory and customer requirements. Recognize the need for revisions to existing and/or development of new procedures. Keep track of draft documents and ensure their timely completion.
• Monitor timely processing of change requests. Ensure that all change requests are processed according to the approved procedures.
• Assist in creation, review and/or formatting of procedures. Ensure that all procedures meet the company approved standard operating procedure format.
• Undergraduate Degree with additional experience in a related field will be considered
• Quality Assurance/ISO training in current regulations and requirements
• Preference for experience in a Biology/Life Sciences or medical devices company
• Good technical writing skills including attention to detail when writing SOP’s
• Strong problem solving and analytic skills
• Computer skills:
o MS Office
• Strong Excel skills
o ACCESS experience an asset
To apply for this opportunity, please send your resume and a cover letter to: