About the Company - Cellistic is growing, and we’re looking for passionate team members who believe in the power of engineered cells as medicines, challenge the status quo, and thrive on bringing novel ideas to life.
About the Role - We are seeking a detail-oriented and reliable Quality Assurance (QA) Specialist to support our growing biotech operations. The focus of this role will be to play a key role in maintaining and improving the Quality assurance system to support GMP operations related to iPSC manufacturing. The QA Specialist will report directly to the QA Manager and collaborate closely with other departments to ensure that materials, equipment, and products meet the required quality standards. This position will support, material qualification, equipment qualification, quality documents review and approval, and day-to-day QA operations.
Ensure the appropriate good manufacturing practices (GMP) guidelines are implemented in Cellistic quality management system
Participate in the equipment qualification/validation as QA review and approval
Participate in the design, implementation, and continuous improvement of Quality Management Systems (QMS)
Monitor and edit the quality management system of Cellistic with KPI
Draft, Review and approve comprehensive documentation, including standard operating procedures (SOPs), protocols, reports and quality items (change control, Event, CAPA)
Participate in the development and delivery of GMP training programs to staff
Act as Quality SME for quality items (e.g. deviation, CAPA)
Provide support to the quality operations activities
Provide support to risk analysis and coordinate when needed risk management
Promote Quality Mindset
Qualifications - Master degree in Pharmaceutical Sciences, Biology, Chemistry, Biomedical Sciences, Biotechnology Engineer or equivalent through experience
At least 3-5 years' experience in quality assurance function within pharmaceutical or biotechnology industry
Expertise in GMP and pharmaceutical industry standards, GMP for ATMP is an asset
Self-motivated, enthusiastic personality, team player
Languages: Fluent in English and French – Minimum Level B2
Proficient knowledge of Office 365 applications (Word/Excel/Access/PPT)
Application Process: