Dawit Tegegn
Laboratory Quality Associate
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About
Works with Pharmaron QA and Laboratory Leadership in ensuring quality standards are followed, maintained, and documented.
Experience
Laboratory Quality Associate - Pharmaron CPC - Baltimore, Maryland 21201
(2023-01 - 2025-10)
Works with Pharmaron QA and Laboratory Leadership in ensuring quality standards are followed, maintained, and documented.
- Assist with specimen reconciliation, quality review of study documents, quality control of specimen labels, shipments, and study worksheets/manifests.
- Responsible for identifying quality problems and recommending solutions.
- Assists in the review and assessment of compliance within the laboratory sections with regulatory standards including CLIA, COLA, GLP
- Maintains and monitors study documentation and materials; review for completeness, responds to audit requests for document retrieval.
- Assist with specimen processing attributes as needed. This includes receives, process, centrifuge, aliquot, and store specimens in compliance with IRB approved protocol and protocol specific lab manual.
- Performs bench top waived tests (ex. Serum/urine hcg tests, HIV antibody/antigen qualitive test, UDS, Covid PCR test)
- Daily instrument calibration/QC of UA, Hematology analyzer, Coag. analyzer, chem/serology analyzer
- Trouble shooting lab information management systems
Lab Assistant/Specimen Processor - Pharmaron CPC, Inc. - Baltimore, MD
(2023-06 - 2023-02)
- Lab Assistant
- Verify complete sample requisitions for core lab tests.
- Generate specific labels to identify samples for the lab, clinical team and outpatient phlebotomy.
- Ordering tests in internal laboratory information system for chemistry, hematology and coagulation Analyzer Tests
- Running waived lab test (pregnancy test, urine drug screening, HIV Tests, GeneXpert COVID/Flu PCR testing)
- Daily maintenance and quality control of lab equipment/analyzers.
- Specimen Processing
- Received, centrifuge, aliquot, and stored laboratory specimen in compliance with the IRB.
- Approved protocol and the final version of the protocol-specific laboratory manual.
- Documented each stage of PK processing (i.e., in/out centrifuge, etc.).
- Affixed specimen labels to PK cryovial tubes prior to initiating the specimen processing.
- Organized PK Cryovials
Lab Operation Technician - Thermo Fisher - Frederick, MD
(2021-08 - 2022-06)
- Disease prevention repository technician
- Responsible for receipt, inventory, storage, withdrawal, and shipment of biological specimens for commercial and government clients.
- Enter bio-samples that are received at the depository into a database. Which allows tracking completion of objectives according to QC standards and work-related timelines.
- Stored various Bio-samples at temperatures ranging from ambient to below freezing in Nitrogen liquid tanks.
- Reese monitoring of Freezers and N2 tanks
Sales Associate/ Assistant Manager - Racquet and Jog Sports - Rockville, MD
(2015-08 - 2021-06)
Education
Bachelor of Science - Biochemistry and Molecular Biology - University of Maryland – Baltimore County (2020-12)
Associate of Science - General Studies - Montgomery College (2016-05)

