Thalia Bennett
Milton,MA
Summary
Quality control professional with expertise in analytical testing and regulatory compliance within biotechnology. Skilled in flow cytometry and qPCR, with a strong focus on root cause analysis to enhance quality standards. Proven track record of driving continuous improvement initiatives.
Overview
2
2
Languages
4
4
years of professional experience
Work History
Senior Quality Control Specialist
Vertex Pharmaceuticals
03.2025 - 03.2026
- Supported quality and regulatory compliance activities for a stem cell-based Type 1 Diabetes program in a cGMP/cGDP environment.
- Performed release, in-process, validation, and stability testing using flow cytometry, qPCR, ELISA, sterility, endotoxin, Gram stain, and cell count methodologies.
- Conducted technical review of analytical data and laboratory documentation to ensure accuracy, completeness, and compliance with internal quality standards.
- Led CAPA investigations, Quality Events, and root cause analyses to drive continuous quality improvement.
- Revised SOPs and on-the-job training documentation to ensure compliance and standardize laboratory procedures.
- Collaborated with Analytical and Process Development teams to enhance assay optimization and facilitate laboratory investigations.
- Maintained accurate laboratory records and documentation in accordance with FDA, cGMP, and cGDP requirements.
Reagent Quality Control Associate II
Vizgen
05.2023 - 09.2024
- Conducted analytical and functional quality testing of reagent products to support efficient manufacturing operations.
- Aided in validation of new testing procedures, ensuring adherence to GMP documentation requirements.
- Investigated failed runs and supported root cause analysis and corrective actions.
- Maintained QC databases and batch records to support product quality and regulatory compliance.
- Coordinated with Manufacturing to facilitate timely product release and maintain accurate quality documentation.
Medical Laboratory Scientist I
Brigham & Women's Hospital
03.2022 - 04.2023
- Performed complex molecular diagnostic testing using PCR, RT-PCR, NGS, Sanger sequencing, Luminex, and Mass Spectrometry platforms.
- Interpreted quality control results and ensured accurate documentation of testing activities.
- Ensured compliance with regulatory and institutional standards by maintaining QA/QC documentation and laboratory records.
- Contributed to development of SOPs, protocol revisions, assay validation, and laboratory process improvements.
- Facilitated troubleshooting and validation of laboratory equipment and molecular assays to enhance operational reliability.
- Trained new laboratory personnel on laboratory procedures and documentation requirements.
Education
Bachelor of Science - Medical Molecular Biology
MCPHS University
Boston, MA05-2021
Skills
- Regulatory compliance
- CGMP/CGDP standards
- Quality documentation
- SOP development
- Validation documentation
- QA/QC documentation
- Data integrity
- Flow cytometry analysis
- qPCR / RT-qPCR methods
- ELISA testing
- Endotoxin (LAL) testing
- Sterility testing procedures
- Gram staining techniques
- Cell counting methodologies
- Corrective action
- Root cause analysis (5 Whys)
- Quality events management
- Change control
Languages
Spanish
Native/ Bilingual
English
Native/ Bilingual
Timeline
Senior Quality Control Specialist
Vertex Pharmaceuticals
03.2025 - 03.2026
Reagent Quality Control Associate II
Vizgen
05.2023 - 09.2024
Medical Laboratory Scientist I
Brigham & Women's Hospital
03.2022 - 04.2023
Bachelor of Science - Medical Molecular Biology
MCPHS University