Operational Management: Directs daily lab workflow, ensuring turnaround time goals are met.
Quality Assurance & Compliance: Monitors quality control (QC) and assurance (QA) documentation, ensuring compliance with state, federal, and accreditation standards.
Personnel Management: Supervises, trains, and mentors staff, addresses performance gaps, and handles scheduling.
Performs accurate clinical/diagnostic testing, routine, specialized, and esoteric testing, according to standard operating procedures (SOPs) on human biological samples within the scope of one’s education and training.
Analyzes, interprets, and reports laboratory results according to protocols and regulatory requirements.
Performs molecular techniques such as real-time PCR, DNA methylation analysis, and next-generation sequencing.
Prepares Corrective and Preventive Action (CAPA) documents for nonconformance events observed during pre-analytical, analytical, and post-analytical clinical laboratory testing.
Senior Quality Assurance Specialist
Health Wright Products
Portland, OR
01.2021 - 10.2021
Document, review, and release for use all raw materials, packaging, and labeling supplies used within the manufacturing process for dietary supplements.
Responsible for documenting any internal non-conformances and out-of-specification conditions, investigating the root cause, recommending corrective actions, and making appropriate decisions for resolving such non-conformances and out-of-specification conditions.
Support the QC Manager during the investigations into any non-conformances.
Facilitate the development of methods and procedures for the quality control/quality assurance group.
Lab Scientist
National Reference Lab-Sudan
Khartoum
01.2014 - 04.2019
Organize and perform pre-study activities (e.g., planning, protocol development, animal, and reagent ordering)
Perform study procedures (formulations, cell culture, dosing, treatments, sample collections, and tissue collections).
Perform sample processing and analysis (e.g., qPCR, immunoblot, and ELISA analysis)
Design of in vivo pharmacology, safety, and PK/PD studies.
Performs laboratory procedures following protocols including deoxyribonucleic acid (DNA) sequencing, cloning, extraction, ribonucleic acid (RNA) purification, or gel electrophoresis.
Utilizes a Flow Cytometer for optimum data acquisition, analysis, manipulation, validation, and quality control purposes.
Processes, analyzes and sorts specimen samples from bone marrow, blood, and various other tissues.
Analyzes and prepares preliminary data.
Provides instruction and guidance to researchers and core trained users, including scheduling, analysis and sorting of samples, and basic equipment questions and problems.
Education
Bachelor of Science - Pharmaceutical Sciences - Clinical Pharmacology
Clinical Laboratory Supervisor at Advent Health Wesley Chapel and Central Pasco ERClinical Laboratory Supervisor at Advent Health Wesley Chapel and Central Pasco ER