• Create virtual test environments • Work on the creation, population, and maintenance of third-party repositories to keep them up-to-date • Maintain repositories using a combination of manual and automated workflows • Perform product testing • Support existing and developing new automation scripts • Create and document bug reports in the bug tracker • Collaborate with the development team • Participate in the preparation and support of releases

• Support the implementation, revision, and maintenance of QA programs, policies, and procedures to ensure compliance with cGMP, FDA, and ICH requirements. • Assist in updating SOPs to mitigate compliance gaps and support commercial QA readiness. • Support QA activities related to drug substance tech transfer, process performance qualification (PPQ), and preparation for process validation activities. • Ensure QA compliance of validation protocols, reports, and associated GMP documentation during execution. • Perform QA review of batch production records, validation data, deviation investigations, and analytical documentation associated with drug substance manufacturing to ensure accuracy, completeness, and compliance with GMP standards. • Support timely disposition activities once all required data is available. • Serve as a QA point of contact for assigned contract manufacturers and partners by supporting QA oversight activities. • Support and participate in GMP audits for vendor qualification or requalification (minimum of two), including preparation, execution support, and documentation of findings. • Perform QA review of manufacturing, validation, and analytical documents related to API/drug substance release testing, stability programs, raw materials, intermediates, and analytical method qualification/validation to ensure compliance with regulatory expectations. • Support the review and resolution of quality system events, including deviations, CAPAs, change controls, and out-of-specification investigations.

• Help validate end-to-end workflows • Support delivery quality

• Test new features and bug fixes across Employee, Client, and Admin portals before release • Perform full regression testing before deployments • Create detailed bug reports in Asana, including reproduction steps, severity, environment details, and supporting evidence • Validate bug fixes before closing tickets • Proactively test edge cases across devices, user roles, and environments • Conduct daily check-ins with the development team to track progress and resolve blockers • Maintain a log of known issues and provide weekly status updates to the CEO • Review user stories and acceptance criteria to ensure proper testing coverage • Own the end-to-end QA process and ensure platform quality before release