• Assist QA Leadership with development and execution of planned QA audit schedules supporting GMP activities • Partner with Technical Operations with selection and ultimate oversight of drug substance / drug product contract development manufacturing organizations (CDMOs) in support of Phase 3 and process performance qualification (PPQ) activities • Independently performs assigned GMP audits • Partner effectively with Technical Operations and provide quality guidance in GMP data and documentation generated • Verify manufacturing and testing activities adhere to GMP regulations and guidelines and ensure a culture of continuous improvement • Timely management of batch record review and release to ensure continuous supply for clinical trials, and to guarantee the consistent production of high-quality products • Ensure manufacturing processes, facilities, and systems adhere to current GMP regulations, guidelines, and industry standards • Provide QA support of device development activities (pre-filled syringes, autoinjectors, etc.) • Maintain robust GMP quality systems, including documentation, change control, deviations, CAPA, and quality events • Maintain knowledge of current regulatory changes and industry trends and translate new requirements back to the company’s policies and procedures • Implement risk-based approaches to quality management, identifying and mitigating quality risks across the organization • Assist in establishing and reporting key quality metrics to monitor performance and drive improvements in GMP compliance and product quality • Drive a culture of continuous improvement, identifying areas for enhancement in quality systems and processes to enhance efficiency and effectiveness • Ensure employees are adequately trained in GMP requirements and quality procedures • Maintain comprehensive and accurate records and reports related to quality assurance activities • Foster a culture of quality within the organization, emphasizing the importance of compliance, data integrity, and patient safety • Assist in GMP inspection readiness activities to support regulatory authority inspections

• Perform network-based penetration testing for our clients to identify, assess, and report on vulnerabilities in their public facing infrastructure. • Perform penetration testing on web applications and APIs (internal and external) to identify, assess, and report on vulnerabilities in their applications. • Perform red team exercises to determine where weaknesses in the client’s infrastructure and how it should be remediated. • Write clear, concise, effective deliverable reports for clients to help them understand their risk posture and how they can reduce it. • Advise clients on security best practices including application design, infrastructure architecture design, and other considerations. • Collaborate with other Crosslake practitioners to socialize penetration testing best practices.

• Execute functional, exploratory, and regression testing across complex enterprise workflows • Validate data integrity using SQL; trace defects with precision across multi-system environments • Manage and maintain test cases in TestRail; track work items in Azure DevOps • Collaborate closely with engineering teams — communicate findings clearly and act as a quality advocate • Build toward automation ownership using Playwright or similar frameworks as the role matures

• Help ensure the quality, accuracy, and reliability of web portals, BI dashboards, surveys, and data pipelines • Test web portal functionality built with Blazor, Bootstrap, and SSO authentication • Validate login/logout flows, session timeouts, token refresh, role-based access, and access restriction scenarios • Review UI/UX consistency across desktop and tablet views, including forms, modals, validations, and error messages • Test request forms, multi-step workflows, conditional fields, file uploads, backend submissions, and confirmation messages • Validate dashboard widgets, KPI cards, data grids, filters, date pickers, and CSV/PDF export functionality • Test BI dashboards to ensure charts, tables, filters, drill-downs, tooltips, and exports display accurate data • Verify dashboard performance, especially when working with large datasets or complex visualizations • Test survey flows, question types, validation rules, submission logic, confirmation pages, and email invitation links • Write and execute SQL queries to validate row counts, aggregates, joins, data freshness, and data integrity • Compare data across sources such as SQL databases, Excel files, CSV exports, and dashboard outputs • Validate ETL and data pipeline processes to ensure information is correctly extracted, transformed, and loaded • Perform cross-system testing to confirm that portal actions, survey submissions, dashboards, and access permissions work together correctly • Work closely with the Engineering Manager, PM, and development team to identify, document, and follow up on defects