Ryan Burke, Quality Assurance Specialist

Nexcella

Mar 2025 – Present

Rancho Cordova, CA

Quality Assurance Specialist

Ensure compliance with cGMP, FDA, EMA, and other regulatory requirements for advanced therapy medicinal products (ATMPs), including gene and cell therapies. • Review and approve batch records, deviation investigations, CAPAs, and change controls related to clinical and commercial manufacturing activities. • Perform real-time quality oversight of manufacturing operations including aseptic processing, cleanroom behaviors, and critical process steps. • Participate in internal and external audits; support regulatory inspections and responses. • Review and approve controlled documents including SOPs, work instructions, and validation protocols. • Collaborate with cross-functional teams including Manufacturing, QC, MSAT, and Regulatory to drive continuous improvement. • Support training programs to ensure personnel are qualified and current with QA/GMP requirements. • Contribute to risk assessments, quality improvement projects, and facility startup/technology transfer activities. • Provide quality oversight of electronic systems used in manufacturing and laboratory environments (e.g., MES, LIMS, QMS, CDS), ensuring data integrity and 21 CFR Part 11 compliance. • Participate in Computer System Validation (CSV) activities, including review and approval of validation plans, test scripts, and system lifecycle documentation.

Westpac Group

Nov 2024 – Dec 2024

Sydney, Australia

Information Security Governance Intern

Maintained security operations and worked on tasks relating to strengthening overall security posture for the organization. • Analyzed problems and worked across multiple teams to develop solutions pertaining to vendor management and implementation of program applications. • Maintained quality assurance for ongoing projects, working closely with third party vendors to meet SLA's and guideline requirements. • • Maintained database systems to track and analyze operational data. Initiating regression, performance, automated and manual testing of security applications and data sets. • • Participated in workshops and presentations related to ongoing projects. Conducted research for various projects, leading to well-informed decisions and successful outcomes. • Developed test plans, strategies, business, and technical specifications for security related projects

Los Rios Community College District

Nov 2019 – Apr 2021

Folsom, CA

Campus Patrol Officer

Managed and assessed building access control systems as well as security control systems • Interacted with citizens and supported positive relationships between community leaders and officials • Established protocol procedures and guidelines for personnel in the event of emergencies • Patrolled and monitored campus and operations, took incoming service calls from dispatch and authorized personnel

Los Rios Community College District

Jun 2018 – Nov 2019

Folsom, CA

Campus Operations & Printing Services

Managed and coordinated scheduling for events and services using technology such as Ad Astra, Microsoft Excel, and Microsoft Word • Worked and managed control systems for fields, scheduled lighting and sprinkler systems while coordinating with groundskeeping • Managed facility maintenance and scheduling, overseeing repairs, renovations, and routine inspections to uphold campus standards • Managed daily operations of the campus printing services, ensuring timely and accurate print production for academic and administrative departments • Monitored inventory levels of printing supplies, coordinating timely orders to prevent shortages and meeting deadlines for campus events

Ryan Burke

Quality Assurance Specialist

Skills

Languages