RACHEL WON
Elkridge,USA
Summary
Medical Laboratory Scientist with expertise in regulatory compliance and quality assurance at University of Maryland Medical Center. Demonstrated success in optimizing workflows and improving specimen management processes. Skilled in cross-functional collaboration and problem-solving, delivering timely and accurate results while upholding integrity and safety standards.
Overview
12
12
years of professional experience
1
1
Certification
Work History
Medical Laboratory Scientist
University of Maryland Medical Center
Baltimore, MD
05.2025 - Current
- Coordinate send-out testing processes, ensuring timely sample handling, accurate preparation, and effective shipping.
- Serve as liaison between internal departments and external reference laboratories to track test status and resolve discrepancies.
- Monitor specimen integrity and labeling accuracy to prevent processing delays; followed up on rejected samples.
- Validate send-out results for data accuracy and ensured timely communication with clinical teams and physicians.
- Ensure compliance with CAP, CLIA, HIPAA, and internal QA/QC standards in send-out lab activities.
- Participate in continuous improvement of workflows by identifying inefficiencies and implementing corrective actions.
- Manage laboratory supplies inventory to guarantee availability for all tests.
- Respond to clinical and customer concerns, resolving issues confidentially with integrity.
Quality Assurance Manager
Psomagen Inc
Rockville, Maryland
08.2023 - 05.2025
- Conducted quality reviews of laboratory functions for environmental response and biological testing, ensuring compliance with regulatory guidelines and quality management systems.
- Managed continuous compliance and renewal processes for laboratory licensure and accreditation, including submitting applications and method submissions.
- Acted as primary liaison between laboratory and accrediting agencies, facilitating communication on regulatory requirements and compliance matters.
- Optimized clinical sequencing workflow by developing Standard Operating Procedures to improve quality, safety, and reliability.
- Monitored data integrity, sample traceability, and quality control procedures, reporting directly to technical supervisor and laboratory director.
- Created and managed documentation related to Quality Control (QC), Quality Management (QM), and Quality Assurance (QA).
- Directed Corrective and Preventive Action (CAPA) process by tracking non-conformances to ensure adherence to quality standards.
- Oversaw clinical laboratory staff, conducting competency assessments, proficiency testing, and organizing continuing education initiatives.
Project Manager
Psomagen Inc
Rockville, Maryland
08.2020 - 08.2023
- Led and managed clinical and research sequencing projects utilizing Next-Generation Sequencing (NGS) for key clients.
- Ensured strict adherence to deadlines through effective problem-solving and collaboration with cross-functional teams.
- Provided extensive administrative support and coordinated logistics with Sales Representatives.
- Maintained regular communication with stakeholders, delivering project updates and addressing laboratory issues.
- Executed pre-analytical functions, including sample receipt and registration, to streamline laboratory operations.
QA&QC Specialist
Psomagen Inc
Rockville, Maryland
04.2017 - 08.2020
- Managed laboratory workflow to ensure seamless operations and compliance with GCLP, GLP, ISO 9001:2015, CAP, CLIA, and customer requirements.
- Evaluated incoming samples for adherence to established specifications prior to sequencing.
- Conducted quality control assessments of samples by evaluating DNA quality and quantity.
- Verified sequencing results for identity, strength, quality, and purity before releasing final results to clients.
- Analyzed raw sequencing data, identified quality issues, recommended solutions, and executed troubleshooting for improved data integrity.
- Developed regulatory standards and enhanced Standard Operating Procedures (SOP) within the laboratory.
- Led investigations of non-conforming materials using NCR and CAPA processes, organizing troubleshooting meetings for root cause analysis.
- Mentored QA staff to foster professional development and promote process improvements.
Laboratory Scientist
Macrogen Corp.
Rockville, Maryland
03.2015 - 04.2017
- Logged samples and tracked data using Laboratory Information Management System (LIMS) for accurate documentation.
- Conducted high-complexity testing, including bacteria cell cultures, DNA isolation, and capillary electrophoresis.
- Addressed customer inquiries regarding services and analysis results to ensure effective communication.
- Prepared solutions, reagents, and stains according to standard laboratory protocols.
- Monitored equipment performance and adhered to maintenance schedules.
- Executed routine repairs and replaced parts for ABI 3730 XL DNA Analyzer.
- Managed lab inventory and ordered supplies in compliance with established policies.
Assistant Director
C2 Education
Ellicott City, Maryland
05.2014 - 03.2015
- Managed phone inquiries and daily business data to streamline administrative operations.
- Confirmed schedules with students and teachers to ensure organized activities.
- Represented center at school and community events to promote services and engage stakeholders.
- Tracked and analyzed student progress, providing feedback to enhance learning experiences.
Administrative Assistant
The Enterprise Dental Lab
Rockville, Maryland
05.2013 - 12.2013
- Provided comprehensive administrative support for dental laboratory operations, including filing, scanning, and data entry.
- Managed intake and tracking of dental case orders, ensuring timely processing and precise documentation.
- Maintained lab equipment and sterilization records in compliance with OSHA standards.
- Coordinated communication between dental offices and lab technicians to clarify prescriptions and specifications.
Pharmacy Assistant
The University Health Center Pharmacy
College Park, Maryland
05.2013 - 12.2013
- Welcomed customers and received prescription orders efficiently, ensuring professional service.
- Collected personal and medical information with discretion and adherence to confidentiality standards.
- Directed patients with prescription inquiries to pharmacists, facilitating seamless communication.
- Supported daily pharmacy operations through clear communication and attentive service.
Education
Bachelor of Science - Chemistry
University of Maryland
College Park, MarylandSkills
- Regulatory compliance: GCLP, CAP, CLIA
- Quality assurance and control
- Internal audits and CAPA management
- Deviation investigations and root cause analysis
- SOP development and document control
- Process improvement and risk assessment
- Specimen management
- Problem solving
- Cross-functional collaboration
- Specimen handling
- Laboratory management
Certification
- ISO 9001:2015 Certification of the QMS, BSI Korea
- 2024 ESET Cybersecurity Awareness Training, CSET
- 2024 SteriCycle OSHA and HIPAA Certificates
Languages
Korean: Native/ Bilingual
Timeline
Medical Laboratory Scientist
University of Maryland Medical Center
05.2025 - Current
Quality Assurance Manager
Psomagen Inc
08.2023 - 05.2025
Project Manager
Psomagen Inc
08.2020 - 08.2023
QA&QC Specialist
Psomagen Inc
04.2017 - 08.2020
Laboratory Scientist
Macrogen Corp.
03.2015 - 04.2017
Assistant Director
C2 Education
05.2014 - 03.2015
Administrative Assistant
The Enterprise Dental Lab
05.2013 - 12.2013
Pharmacy Assistant
The University Health Center Pharmacy
05.2013 - 12.2013
Bachelor of Science - Chemistry
University of Maryland
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