Semhal Negussie
Silver Spring,MD
Summary
Biomanufacturing associate with QA documentation and audit experience seeking a QA specialist role.
Overview
4
4
years of professional experience
Work History
Biomanufacturing Associate
Charles River Laboratories
Rockville
07.2025 - Current
- Prepared and filtered buffers and media following GMP and aseptic techniques, ensuring correct pH and conductivity.
- Executed tangential flow filtration for concentration and diafiltration steps.
- Operated AKTA for purification workflows, including column packing.
- Performed accurate pipetting and aseptic handling inside a BSC to maintain sterility and prevent contamination.
- Operated PendoTech pressure monitoring systems to track filtration during purification steps.
- Utilized MasterFlex peristaltic pumps for the controlled transfer of buffers.
- Conducted in-process checks, monitored pressure and flow readings, and recorded data for batch production for records for QC and QA review.
Inpatient Lab Assistant
Quest Diagnostics
Silver Spring
08.2023 - Current
- Performed venipuncture and capillary blood draws for inpatient units, including ER, ICU, pediatrics, and oncology.
- Collected STAT, timed, a routine specimen while prioritizing critical and emergency draws.
- Utilized PPE and followed CLIA and HIPAA standards.
- Received, accessioned, and processed incoming specimens for chemistry, hematology, microbiology, urinalysis, and send-outs.
Operations Specialist
ThermoFisher Scientific
Rockville
02.2022 - 08.2023
- Conducted internal audits to ensure compliance with cGMP, SOPs, and client-specific quality requirements.
- Identified gaps, deviations, and documentation issues.
- Served as a point of contact for clients, providing updates on sample status, project timelines, and compliance requirements.
- Received and logged biological specimens following strict chain of custody, biosafety, and documentation procedures.
Education
Medical Technology
George Washington University
Washington, DC05-2027
Medical Technology
Northern Virginia College
Arlington, VA11.2025
Washington Adventist University
Takoma Park, MD05-2021
High School -
Bethesda Chevy Chase HS
Bethesda, MD05-2020
Skills
- Biomanufacturing processes
- Aseptic techniques
- GMP compliance
- Attention to detail precision
- Leadership qualities
- Organizational skills
- Efficient communication
Timeline
Biomanufacturing Associate
Charles River Laboratories
07.2025 - Current
Inpatient Lab Assistant
Quest Diagnostics
08.2023 - Current
Operations Specialist
ThermoFisher Scientific
02.2022 - 08.2023
Medical Technology
George Washington University
Medical Technology
Northern Virginia College
Washington Adventist University
High School -
Bethesda Chevy Chase HS