Tyler Romano
Media
Summary
Quality assurance professional specializing in GMP-regulated environments for cell and gene therapy. Expertise in document control, lot release, deviation investigations, CAPA, and change control. Ensures regulatory compliance and maintains quality systems while collaborating across teams to enhance manufacturing operations within FDA and CFR 21 standards.
Overview
5
5
years of professional experience
Work History
Quality Assurance Specialist
US WorldMEDS
09.2025 - 03.2026
- Perform material and lot release activities to ensure compliance with regulatory requirements and internal quality standards.
- Conduct manufacturing inspections and line clearances to verify production readiness and adherence to cGMP standards.
- Lead and support deviation investigations, ensuring thorough root cause analysis and timely resolution.
- Initiated and managed Corrective and Preventive Actions (CAPA), enhancing quality improvement efforts through systematic resolution of issues.
- Reviewed and implemented change control documentation, ensuring regulatory compliance while facilitating controlled process modifications.
- Managed document control processes, ensuring accuracy in issuance, review, approval, maintenance, and archival of controlled GMP documentation.
Quality Assurance Specialist
Adaptimmune
01.2025 - 09.2025
- Executed material and lot release approvals, aligning with internal quality systems and regulatory standards to support product integrity.
- Oversaw GMP document control and quality documentation review, ensuring regulatory compliance and accuracy.
- Conducted manufacturing floor inspections and line clearances to verify adherence to cGMP procedures and batch record requirements.
- Collaborated with manufacturing and quality teams, reinforcing consistent quality oversight during production operations.
Manufacturing Cell Therapy Specialist
Adaptimmune
05.2023 - 01.2025
- Manufactured clinical and commercial cell and gene therapy products in compliance with cGMP regulations (CFR 21) and internal SOPs.
- Executed aseptic processing techniques while maintaining strict adherence to GMP documentation and batch record requirements.
- Performed cell cryopreservation, expansion, and harvest operations supporting commercial production of TECELRA cell therapy products.
- Investigated process deviations and non-conformances, initiating CAPAs and managing action items to mitigate risks and prevent recurrence effectively.
- Authored and revised Standard Operating Procedures (SOPs) and controlled documentation, enhancing operational efficiency and ensuring compliance.
- Led Equipment Team, coordinating with vendors and internal facilities teams to ensure timely calibration, maintenance, and operational readiness of equipment.
- Conducted equipment investigations and troubleshooting to minimize manufacturing downtime and maintain compliance.
- Acted as a Qualified Trainer, delivering training on SOPs, equipment operation, and manufacturing procedures to new and existing staff.
Manufacturing Associate I
Wuxi AppTec
08.2022 - 05.2023
- Supported production of clinical and commercial cell and gene therapy products within a regulated cGMP manufacturing environment.
- Executed aseptic processing procedures while ensuring accurate completion of batch records and manufacturing documentation.
- Authored and revised complex SOPs, batch records, and product specification documents to support process improvements and regulatory compliance.
- Participated in technology transfer activities, authoring SOPs and batch records while conducting client process gap assessments.
- Documented and investigated non-conforming events (NCEs) and deviations, implementing safety and process improvements across manufacturing operations.
- Provided training and mentorship to team members on SOP compliance, equipment use, and manufacturing best practices.
- Processed tumor tissue, expanded cells, and harvested for TIL (Tumor Infiltrating Lymphocyte) immunotherapy manufacturing, contributing to successful product development.
PT Technician
Strive Physical Therapy
Moorestown
06.2021 - 07.2022
- Assisted physical therapists in implementing patient treatment plans, contributing to adherence to clinical protocols and safety standards.
- Supported patient mobility and therapy exercises, ensuring safe equipment operation and proper technique for optimal patient outcomes.
- Prepared treatment areas and equipment, facilitating efficient patient care and smooth appointment flow.
- Maintained strict compliance with HIPAA privacy regulations and patient confidentiality requirements.
- Developed strong communication and patient support skills in a fast-paced clinical environment.
Education
Bachelor of Science - Biology
Widener University
Chester, PA12-2020
Skills
- cGMP compliance (21 CFR)
- Quality Management Systems
- SOP development
- Deviation Investigations
- CAPA management
- Change Control Management
- Risk Assessment & RCA
- Document Control
- Batch Record Review (GMP)
- Material & Lot Release
- Manufacturing Line Clearance
- Aseptic Processing
- Gene therapy manufacturing
- Continuous Process Improvement
Leadership Experience
Biology Mentoring Program – Chester, PA
Sep 2019 – Dec 2019
• Mentored first-year biology students, providing academic support and guidance within the university science program.
• Led group study sessions to reinforce foundational biology concepts and improve student comprehension.
• Guided students in developing effective study strategies and problem-solving approaches for science coursework.
• Communicated complex scientific concepts in a clear and accessible way to support student success.
Timeline
Quality Assurance Specialist
US WorldMEDS
09.2025 - 03.2026
Quality Assurance Specialist
Adaptimmune
01.2025 - 09.2025
Manufacturing Cell Therapy Specialist
Adaptimmune
05.2023 - 01.2025
Manufacturing Associate I
Wuxi AppTec
08.2022 - 05.2023
PT Technician
Strive Physical Therapy
06.2021 - 07.2022
Bachelor of Science - Biology
Widener University