Grace Charles Mazinga

Quality focused medical laboratory scientists with over three years of experience in clinical diagnostics, laboratory operations, quality assurance and regulatory compliance with GCLP regulated clinical research environments. Experienced in quality control monitoring, method verification, equipment qualification, safety management, audit preparation and continuous improvement initiatives. Proven ability to maintain accurate documentation, investigate quality issues, optimize workflows and collaborate across multidisciplinary teams to ensure laboratory compliance and operational excellence.

Seeking to expand expertise in quality management system [QMS], GMP and regulated product quality environments.

Laboratory Technologist in Core Lab – Tidziwe Centre - UNC Project-Malawi (DAIDS Clinical Research Site Safety Laboratory) - Malawi

(2021-08 - 2023-12)

• Performed routine and non-routine testing across hematology, clinical chemistry, microbiology, serology, molecular diagnostics, and immunoassay platforms within a GCLP-regulated clinical research laboratory.
• Independently performed hematology and clinical chemistry testing and reviewed analytical performance using Levey–Jennings charts, Westgard rules, calibration verification, quality trending, and investigation of out-of-control events to ensure accurate and reliable results.
• Operated, calibrated, maintained, and troubleshot laboratory instrumentation including BD DxH Hematology Analyzers, Cobas c311 Clinical Chemistry Analyzers, GeneXpert, Abbott m2000, and BD BACTEC systems.
• Supported method verification, method comparison, analyzer implementation, and performance evaluation studies for hematology and clinical chemistry platforms.
• Maintained complete, accurate, and audit-ready documentation in compliance with GCLP, SOPs, and regulatory requirements.
• Participated in proficiency testing, quality investigations, root cause analysis, corrective actions, and continuous improvement initiatives to strengthen laboratory quality systems.
• Collaborated with laboratory management and multidisciplinary teams to optimize workflows, ensure compliance, and maintain operational excellence.

Acting Laboratory Operations Officer - UNC Project-Malawi (DAIDS Clinical Research Site Safety Laboratory) - Malawi

(2021-08 - 2023-12)

• Managed laboratory operations during a six-month maternity leave assignment, ensuring uninterrupted testing services and regulatory compliance.
• Generated laboratory utilization reports by study, platform, and testing volume to support budgeting, forecasting, and operational planning.
• Forecasted reagent and supply requirements using historical utilization trends and study enrollment projections.
• Calculated laboratory testing costs, processed investigator billing, and monitored outstanding accounts.
• Coordinated procurement activities and inventory management for laboratory consumables, reagents, and safety supplies.

Acting Safety Officer - UNC Project-Malawi (DAIDS Clinical Research Site Safety Laboratory) - Malawi

(2021-08 - 2023-12)

• Served as Acting Safety Officer for one year while maintaining technical laboratory responsibilities.
• Conducted laboratory inspections, risk assessments, incident reviews, and corrective action follow-up activities.
• Delivered annual safety training programs covering chemical safety, biosafety, biosecurity, and infection prevention.
• Led compliance efforts aligned with ISO 15190 and OSHA 29 CFR 1910.1450 requirements

Research Assistant in Ma Lab (HSF III) IGS - University of Maryland, Baltimore - Baltimore, USA

(2025-07 - 2026-05)

Neonate Intestinal Permeability and Gut Microbiome Study

• Maintained accurate and traceable research records within HIPAA-compliant systems using EPIC and REDCap.
• Managed specimen inventory and chain-of-custody processes through SQL-based tracking databases and inventory controls.
• Performed quality review of clinical and laboratory data prior to database entry and analysis.
• Supported protocol compliance, documentation management, and study workflow standardization.
• Collaborated with clinical and research teams to ensure specimen integrity and data quality throughout study operations.

Laboratory Assistant in the Biological Science Teaching Laboratory - University of Eastern Africa, Baraton - Kenya

(2018-09 - 2021-04)

Entomology, Ecology, Genetics, Microbiology

• Collaborated with faculty and peers to collect and analyze microbial and parasitic samples, ensuring accurate results and adherence to standard operating procedures
• Maintained and calibrated critical laboratory equipment—including incubators, autoclaves, microscopes, centrifuges and biosafety cabinets—and prepared reagents, media, and broths to support multiple experimental groups.
• Tutored students in laboratory techniques and managed detailed GLP compliant records and housekeeping standards, improving operational efficiency and fostering a safe, organized learning environment.

Master of Science - Medical and Research Technology - University of Maryland, Baltimore (2024-08 - 2026-05)

Bachelor of Science - Biological and Biomedical Science - University of Eastern Africa, Baraton (2017-09 - 2021-08)