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Salary: CAD 73,863 - 92,329 / annual
Aspect Biosystems is seeking a Quality Assurance Specialist to develop and oversee quality assurance activities for clinical GMP bioprinted cell therapies. This role is central to building robust quality systems for a regenerative medicine company pioneering AI-powered bioprinting technology and therapeutic cell engineering.
Key responsibilities include: developing and implementing internal QA processes and the company's Quality Management System (QMS); maintaining document control and training programs; identifying process gaps and proposing solutions; providing QA expertise on change management; collaborating with R&D teams to embed quality standards into product designs from early development phases; supporting vendor qualification programs; serving as the QA documentation expert for protocol reviews, SOP creation, data completeness checks, root cause analysis, and corrective/preventive actions; reviewing batch records for GMP compliance; working with CMC and QC teams during processing and testing; developing raw material specifications; supporting equipment qualification; and conducting risk assessments.
Required qualifications: Bachelor's or Master's degree in Biology, Biotechnology, or related discipline, plus 5-7+ years of hands-on experience developing or administrating GMP quality programs in biotech, medical device, or pharmaceutical environments. Demonstrated knowledge of FDA, EMEA, and other regulatory authorities for biologics and pharmaceuticals (medical device experience is a plus). Must be detail-oriented, process-rigorous, results-driven, and thrive in fast-paced, interdisciplinary, entrepreneurial environments. Strong collaborative skills and ability to work across multiple teams required.
Aspect Biosystems is a venture-backed biotech company developing regenerative medicine therapies using proprietary bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. The company is advancing its pipeline across endocrine and metabolic diseases, including diabetes and rare endocrine disorders.
