Eddah Nyabuto
Summary
Quality operations specialist in GMP-regulated medical device and diagnostics manufacturing. Expertise in immunoassay production, documentation control, CAPA support, and inspection readiness for FDA and ISO standards. Skilled in MES/LIMS, SAP BPCS, EPAS, and TrackWise, facilitating continuous improvement and timely delivery across value streams.
Overview
8
8
years of professional experience
1
1
Certification
Work History
Diagnostic Technologist
Abbott Diagnostics
Sligo
12.2023 - Current
- Execute immunoassay manufacturing operations in a GMP/GLP/EHS environment, consistently meeting shift-based output targets.
- Perform line clearances, in-process checks, and batch record verification; complete line closeouts to maintain audit-ready documentation.
- Ensured data integrity and end-to-end traceability with BPCS and EPAS; maintained compliant labels, logbooks, and electronic records per GDP standards.
- Investigated test deviations and non-conformances, documented findings, supported root cause analysis, and implemented/tracked CAPAs in TrackWise.
- Place/review product on Quality Hold and support timely disposition decisions with quality engineers.
- Conducted GMP process walks and housekeeping checks, reinforcing safety and adherence to procedures.
- Lead/participate in CI initiatives that reduced downtime and waste, improving OEE and first-pass yield.
Adjunct Lecturer & Laboratory Technician
Jaramogi Oginga Odinga University of Science & Technology
Kenya
06.2020 - 05.2022
- Delivered practical instruction in microbiology and molecular biology ensuring strict compliance with SOPs, safety, and documentation standards.
- Authored and reviewed SOPs and lesson plans while mentoring undergraduate research to uphold strong data integrity practices.
- Developed course materials to enhance student learning and engagement.
- Delivered lectures on various subjects to diverse student populations.
- Facilitated discussions to encourage critical thinking among students.
Biotechnologist
Kisii County
Kenya
01.2018 - 05.2020
- Executed cell culture, molecular, and analytical workflows in regulated labs, optimizing methods to enhance throughput and reproducibility.
- Oversaw documentation, inventory, and safety systems to ensure compliance and operational readiness of equipment.
- Conducted research on local agricultural biotechnology applications.
- Developed protocols for laboratory experiments and field trials.
- Analyzed soil and water samples for contamination levels.
Education
MSc - Bioprocessing Science
Atlantic Technological University
Sligo, IrelandMSc - Biotechnology
Maharshi Dayanand University
Rohtak, IndiaBSc - Biotechnology
Periyar University
Salem, IndiaSkills
- GMP compliance; QSR and ISO (eg, ISO 13485) knowledge
- FDA/ISO quality systems familiarity
- Non-Conformance management: NCRs, root cause analysis, CAPA, NR
- Quality inspections: product review, quality hold, disposition
- Documentation and record control; GDP; audit readiness
- KPI tracking and reporting for quality metrics
- Data analysis of manufacturing data; trend and pattern identification
- Continuous improvement and problem-solving (Lean/Six Sigma mindset)
Certification
- GMP/GDP, EHS site inductions (Abbott)
- Lean/Six Sigma awareness
- Data integrity (ALCOA+) training
Accomplishments
- Maintained zero critical deviations during inspections through complete, GDP-compliant batch documentation and readiness.
- Supported CI initiatives that reduced downtime and optimized workflow performance.
- Proactively identified testing deviations and drove effective CAPA actions with cross-functional teams.
Availability
4 weeks notice period
Right To Work
Eligible to work in Ireland
Tools And Systems
- LIMS
- MES
- SAP BPCS
- EPAS
- TrackWise
- MS Excel/Word/PowerPoint
Timeline
Diagnostic Technologist
Abbott Diagnostics
12.2023 - Current
Adjunct Lecturer & Laboratory Technician
Jaramogi Oginga Odinga University of Science & Technology
06.2020 - 05.2022
Biotechnologist
Kisii County
01.2018 - 05.2020
MSc - Bioprocessing Science
Atlantic Technological University
MSc - Biotechnology
Maharshi Dayanand University
BSc - Biotechnology
Periyar University