Cecilia Maseponki Mokoena
Nelspruit
Summary
Quality Assurance Leader with 18+ years of experience in laboratory and research environments. Expertise in ISO 15189 and ISO 9001 QMS implementation, CAPA management, audit readiness, and risk-based quality management. Quality Assurance Leader with extensive experience in laboratory and research environments. Leads QMS implementation across multiple laboratories, ensuring compliance with ISO 15189 and ISO 9001 standards. Manages CAPA processes and audit readiness, driving continuous improvement and risk management.
Overview
19
19
years of professional experience
Work History
Quality Assurance Coordinator
NHLS
10.2020 - Current
- Lead implementation and oversight of Quality Management Systems across multiple laboratories in compliance with ISO 15189 and ISO 9001 principles
- Drive CAPA processes, including root cause analysis, corrective action implementation, effectiveness checks, and trend monitoring
- Coordinate audit readiness and support external audits (SANAS), ensuring timely closure of findings and sustained compliance
- Facilitate Management Review meetings and present quality metrics to support strategic and operational decision-making
- Implement risk-based approaches to identify, assess, mitigate, and monitor quality and operational risks
- Monitor key quality indicators (IQC, EQA, audit outcomes) and drive continuous improvement initiatives
- Develop and deliver QMS and compliance training programs to ensure staff competency
- Ensure effective document control and lifecycle management of SOPs and quality records
- Collaborate with stakeholders to ensure adherence to regulatory requirements and quality standards
Medical Technologist
Anglo American
05.2020 - 09.2020
- Supported laboratory setup including QMS implementation and SOP development
- Conducted assay verification and validation in line with regulatory and quality requirements
- Trained staff on laboratory procedures, GLP, and quality standards
- Managed laboratory resources and stock control to ensure operational continuity
Research Medical Technologist
Wits RHI
06.2017 - 03.2020
- Ensured compliance with GCP-aligned laboratory practices and supported audit and inspection readiness
- Coordinated quality oversight for clinical research studies, including EQA monitoring and protocol compliance
- Developed and maintained SOPs aligned with regulatory and research requirements
- Performed method validation and verification for clinical studies
- Prepared audit reports and supported CAPA implementation
- Identified and mitigated quality risks within research laboratory environments
Senior Medical Technologist
Ampath
10.2015 - 05.2017
- Monitored IQC and EQA performance, including trend analysis using Levy-Jennings charts
- Supported SANAS accreditation and audit processes
- Trained staff and assessed competency against quality standards
- Ensured compliance with equipment calibration, maintenance, and verification
Medical Technologist
Lancet
06.2007 - 04.2015
- Maintained laboratory QMS and accreditation compliance
- Reviewed QC data and implemented corrective actions
- Ensured adherence to SOPs and quality standards
- Trained laboratory personnel on quality and operational procedures
Education
Coaching & Mentoring Certificate -
01-2025
Postgraduate Diploma in Management -
01-2024
Project Management Certificate -
01-2023
BTech Biomedical Technology -
01-2016
National Diploma Biomedical Technology -
01-2006
Skills
- Quality Management Systems (ISO 15189, ISO 9001 principles)
- CAPA Management & Continuous Improvement
- Risk & Opportunity Management
- Audit & Inspection Readiness (SANAS and PPD exposure)
- Medical Compliance & Quality Governance
- QMS Implementation & Document Lifecycle Management
- Strong governance, compliance, and regulatory focus
- Strategic and operational quality leadership
- High attention to detail and analytical thinking
- Excellent report writing and communication skills
- Regulatory Compliance & Quality Monitoring
- Performance Metrics, Data Analysis & Trend Monitoring
- SOP Development, Review & Control
- Training, Coaching & Competency Management
- Stakeholder Engagement & Cross-functional Collaboration
Websites, Portfolios and Profiles
linkedin.com/in/cecilia-mokoena-3321b8b7
Accomplishments
- Led multi-site QMS implementation and audit readiness initiatives
- Managed non-conformances and CAPA processes to drive continuous improvement
- Facilitated Management Reviews and quality performance reporting
- Supported accreditation and regulatory compliance (SANAS, ISO 15189)
- Implemented risk-based quality improvement strategies
- Trained and mentored staff on QMS, audits, and compliance practices
- Achieved accreditation in 80% of laboratories in my current role
Technical and Regulatory Exposure
- ISO 15189 Quality Management Systems
- ISO 9001 Quality Management Systems
- Risk Management Principles
- Good Laboratory Practice (GLP)
- Good Clinical Practice (GCP) – Research environment exposure
- External Quality Assessment (EQA) Programs
- Internal & External Audits (SANAS readiness)
Timeline
Quality Assurance Coordinator
NHLS
10.2020 - Current
Medical Technologist
Anglo American
05.2020 - 09.2020
Research Medical Technologist
Wits RHI
06.2017 - 03.2020
Senior Medical Technologist
Ampath
10.2015 - 05.2017
Medical Technologist
Lancet
06.2007 - 04.2015