Rafheda Passley
Boston,MA
Summary
Experienced QC professional with a proven track record in leading reagent and cell bank qualification studies, managing method and equipment validations, and ensuring compliance with FDA, EMA, and ICH standards. Adept at technical transfer oversight, deviation investigation, change control and CAPA management. A strong communicator and mentor with a passion for driving continuous improvement across cross-functional teams and regulated environments.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Quality Control Analyst II
2seventybio
Cambridge, MA
10.2023 - Current
- Directed critical reagent qualification studies, serving as study director and leading cross-functional collaborations with QA and manufacturing.
- Managed HOS cell bank qualification and authored technical protocols and final reports.
- Designed and executed pDNA/gDNA testing strategies in support of gene therapy product development.
- Executed equipment validation protocols, including IQ/OQ/PQ.
- Wrote, managed, and drove change controls and CAPAs through to timely closure.
- Utilized JMP for data trending and visualization in support of method performance and investigations.
- Contributed qPCR operational knowledge to FDA audit by preparing supporting documentation and serving as the laboratory SME during inspection sessions
- Designated as Laboratory SME for qPCR operations and performance, troubleshooting assay variability, and supporting continuous improvement.
- Served as a primary point of contact for lab operations, ensuring optimal equipment functionality, reagent readiness, and method performance tracking.
Quality Control Analyst
2seventybio
Cambridge, MA
02.2022 - 03.2023
- Trained new junior analysts on key job performance tasks and responsibilities.
- Author Work Instructions and On the Job training forms.
- Supported commercial GMP labs for release and stability testing.
- Performed cGMP analytical testing (bioassay, pH, osmolality, appearance, ELISA, flow cytometry, qPCR).
Manufacturing Associate 3
Thermofisher
Cambridge, MA
03.2021 - 02.2022
- Performed cell culture operations and media preparation in a cGMP environment, ensuring sterility and product quality.
- Monitored key parameters (pH, temperature, cell viability/density) to maintain process control and consistency.
- Executed manufacturing tasks per SOPs and work instructions with strict compliance to cGMP standards.
- Maintained accurate batch records and documentation to support traceability and regulatory compliance.
Lab Support Team Lead
Beth Israel Medical Center
Boston, MA
07.2020 - 03.2021
- Collected, labeled and stored lab samples according to laboratory specifications.
- Supervise the oversight of laboratory operation
- Manage database(s), and/or spreadsheets and create SOPs
- Execute RT-qPCR tests and results.
- Developed both flow cytometry and ELISA assay skills by performing data analysis utilizing mass spectrometry to distinguish strains of bacteria and viral species.
Lab Technician 2
Siemens Healthcare Diagnostics
Walpole, MA
05.2020 - 02.2021
- implemented and qualified several testing instruments within a new lab space
- Certified in building basepools for Folate BA, HBCT, HBSAG using proteins, preservatives, stocks and diluents.
- Maintained, calibrated, and troubleshoot pH probes, EC meters, balances, automatic pipettes, and diluters.
- Measured and analyzed sample pH levels, moisture saturation and electrical conductivity using pH meters, EC meters.
Student Research Lab Assistant
Bridgewater State University
Bridgewater, MA
10.2017 - 05.2019
- Performed wide range of simultaneous job tasks to support professor's academic, research and operational needs.
- Conducted field studies and formulated research questions and hypotheses.
- Managed departmental inventory and supply ordering.
- Worked successfully with diverse group of coworkers to accomplish goals and address issues related to our products and services.
- Prepared tables, graphs, fact sheets and written reports summarizing research results.
Education
Bachelor of Science - Biology
Bridgewater State University
Bridgewater, MA05.2020
Skills
- Study Director Responsibilities
- Critical Reagent Qualification
- HOS Cell Bank Qualification
- Change Control & CAPA Management
- OOS Investigations & Reporting
- FDA/EMA/ICH Regulatory Compliance
- Technical Transfers & Method Lifecycle
- JMP Statistical Software
- pDNA/gDNA Testing
- Flow Cytometry, Titer, ELISA
- Compendial Testing
- Instrument & Equipment Validation
Certification
Technical Writing Principles
References
Provided upon request
Timeline
Quality Control Analyst II
2seventybio
10.2023 - Current
Quality Control Analyst
2seventybio
02.2022 - 03.2023
Manufacturing Associate 3
Thermofisher
03.2021 - 02.2022
Lab Support Team Lead
Beth Israel Medical Center
07.2020 - 03.2021
Lab Technician 2
Siemens Healthcare Diagnostics
05.2020 - 02.2021
Student Research Lab Assistant
Bridgewater State University
10.2017 - 05.2019
Bachelor of Science - Biology
Bridgewater State University
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