The Quality Assurance Operations co-op provides students with an overview of Gene Therapy Manufacturing - Quality Assurance responsibilities including general knowledge of Quality Review Process of GMP Production Batch Records and Change Controls. The co-op receive hands-on experience in developing the skills to lead and drive Continuous Improvement initiatives aimed at Error Reduction and Quality Review optimization.

Support drug safety and risk management activities across Orca Bio's clinical programs including signal detection, evaluation and management. Assist in the development of risk management strategy and activities for programs, including providing content for RMPs and preparing responses for regulatory authority safety requests. Support safety in clinical trials with review of protocols. Lead the planning, writing and review of periodic safety reports.