BRANDON ASTOR
Rockville Centre
Summary
Dynamic life sciences professional with over three years of experience in biopharmaceutical manufacturing, quality systems, and QC laboratory operations. Expertise includes deviation and nonconformance investigations, contamination analysis, QC data review, and technical writing within regulated environments. Proven track record in cross-functional collaboration, risk assessment, and driving CAPA implementation to enhance compliance and operational efficiency. Committed to advancing quality standards and fostering a culture of continuous improvement in all aspects of operations.
Overview
4
4
years of professional experience
Work History
Theranostics Quality Assurance Specialist
PharmaLogic
03.2026 - Current
- Review and approve GMP documentation including batch records, analytical data, and release documentation
- Lead deviation and nonconformance investigations, ensuring timely closure and effective root cause analysis
- Partner with QC, manufacturing, and regulatory teams to implement CAPAs and mitigate process risks
- Interface with sponsors and clinical sites for batch disposition, audits, and Quality Event Management (QEM)
- Support audit readiness, training initiatives, and continuous improvement efforts
Quality Assurance Specialist
Lantheus (Evergreen Theragnostics)
02.2025 - 02.2026
- Supported batch release, deviation investigations, and CAPA execution within radiopharmaceutical manufacturing
- Coordinated cross-functional workflows across QA, QC, and manufacturing to meet production timelines
- Maintained audit trackers and documentation to support inspection readiness
- Supported documentation readiness for equipment qualification and PQ execution
- Authored Risk Assessments to support highly time-sensitive GMP operations evaluating potential product and patient impact
Senior Associate, Quality Control
Lantheus (Evergreen Theragnostics)
08.2024 - 02.2025
- Conducted stability testing and analytical validation within QC laboratory operations
- Performed root cause analysis for laboratory deviations and supported corrective actions
- Managed laboratory inventory and ensured continuity of testing operations
Associate Scientist
Pfizer
08.2022 - 02.2024
- Led contamination and process variability investigations within upstream development environments
- Reviewed QC data, including mycoplasma testing results, ensuring alignment with internal standards
- Supported flow cytometry assays for product characterization and release readiness
- Authored deviation and investigation reports in compliance with Good Documentation Practices (GDP)
- Collaborated with QC teams to support investigation completion and risk assessments
- Developed data tracking tools improving process visibility and reducing turnaround time by 30%
Education
B.S. - Biomedical Engineering
University of Miami
Training Program - ORAQ Regulatory Affairs
Duke University (Online)
Skills
- Deviation & Nonconformance Investigations
- QC Data Review
- Technical Writing (Investigations, Deviations)
- Contamination Control & Risk Assessment
- GMP & GDP Compliance
- CAPA Implementation
- Flow Cytometry
- Mycoplasma Testing Review
- Cross-Functional Collaboration
- Quality Event Management (QEM)
- Audit Readiness
- Data Analysis (Excel)
- LIMS (Qualio)
- Excel
- R
- SPSS
- FDA / GMP / GDP
- Risk Analysis
- Process Mapping
- Detail-oriented
- Analytical thinking
- Quality assurance
Websites
Timeline
Theranostics Quality Assurance Specialist
PharmaLogic
03.2026 - Current
Quality Assurance Specialist
Lantheus (Evergreen Theragnostics)
02.2025 - 02.2026
Senior Associate, Quality Control
Lantheus (Evergreen Theragnostics)
08.2024 - 02.2025
Associate Scientist
Pfizer
08.2022 - 02.2024
Training Program - ORAQ Regulatory Affairs
Duke University (Online)
B.S. - Biomedical Engineering
University of Miami