Manufacturing QA Consultant (Cell Culture/Therapy)
a Biopharmaceutical company located in Toronto, Canada
Toronto, ON, Canada.
Senior QA Manger, Cell Therapy (Contract)
• Provides Person-In-The-Plant QA oversight of Canadian CDMO operations in support of manufacture of clinical product.
• Reviews manufacturing and support records to confirm compliance with specifications and procedures
• Assists Quality Assurance Management with product disposition activities.
• Reviews and assesses deviations; includes performing risk assessments, participating in root cause analysis investigations, tracking, follow-up and reporting/trending
• Works closely with Manufacturing and Analytical to resolve open issues resulting from record reviews and deviation issues
• Work with all departments to ensure timely completion of manufacturing batch records, deviations, CAPAs, and change controls
• Input batch/lot information into electronic databases
• Review Manufacturing batch records and completes required documentation for batch disposition
• Create, revise and review Quality System documents, including Standard Operating Procedures, protocols, and reports
• Performs data audits, as needed
• Minimum 10 to 12 years’ experience in biopharmaceutical quality assurance
• Cell therapy (cellular therapy, cell transplantation, cytotherapy) products experience is REQUIRED
• Expert knowledge of cGMPs for US and Canada and able to apply cGMPs to complex manufacturing processes.
• Ability to prioritize daily activities in order to meet timelines in a fast-paced environment
• Ability to monitor and report on assigned tasks, goals and objectives
• Excellent written and verbal communication skills
• Experience with clinical product programs is required
• Bachelor’s degree in Life Sciences, or related field.