Lynda E.

Experience

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  College of Medicine, University of Lagos, Nigeria

  Jul 2017 - Jul 2018

  Research Assistant

  • Cultured, Isolated, and identified microorganisms from various clinical samples.• Conducted antibiotic susceptibility testing of isolates against antibiotics recommended by the CLSI and interpreted results and made recommendations for antibiotic therapy.• Assisted in preparing organisms for practical sessions for university undergraduates.

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  Emzor Pharmaceutical Industries Ltd

  Jul 2018 - Jan 2022

  Quality Assurance Specialist

  • Prepared protocols for Stability Studies, monitored and ensured products were withdrawn and sent to the Quality Control laboratories for analysis as per protocol and finalize closing reports on completion of shelf-life.• Review Batch Manufacturing and packaging labels records for completeness and accuracy to ensure compliance with set specification and ensure all non-conformances are documented with appropriate deviation and CAPA implemented.• Review and verify packaging labels and barcodes before approving batch release to the warehouse for shipment.• Managed calibration and validation schedule for all laboratory and process equipment in the facility.• Assigned numbers, tracked, and maintained a logbook of records of all Incidents, Change Control, Deviations, Product Complaints, CAPA, OOS, OOT ensuring all issued forms are closed out as per stipulated timeline. • Managed product retention room ensuring that all manufactured batches are retained as per shelf-life policy and de-shelved on expiry for destruction by regulatory agencies.• Performed batch release of products on Oracle ERP.• Systemized documentation and data control by implementing an archival and retrieval system, facilitating electronic archiving of completed BMRs on M-Files for easy access. • Initiated the preparation and review of QMS documents, Qualification/Validation Protocols, Batch Manufacturing Records, error-free Certificate of analysis of raw materials, intermediate and finished products in line with Good Documentation Practices and relevant SOPs by collaborating with the 6 departmental team leads.• Collaborated with the production, quality, and engineering teams in temperature mapping, process validation (PV), equipment installation (IQ), Operational and Performance qualification (OQ/PQ) from document preparation stage to finalization of validation reports. Show less

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  54gene

  Jan 2022 - Dec 2022

  Data Quality Control Specialist

  • Lead a team of 14 Medical Data Scientists on an ICF review project over a 4-month period to review and upload data for 85,000 informed consent forms saving the organization $10,000 costs in regulatory fines.• Oversaw the Quality Control 7-man team in the review and assessment of data uploads for 6 research study projects (with total estimated recruitment number of 80,000) at various stages on the EDC portal in line with the approved study protocols and acceptance criteria to approve or reject informed consent forms based on the completeness, accuracy, and consistency of the data.• Coordinated the compilation and preparation of SOPs, policies, and process flow charts for carrying out departmental procedures.• Implemented a hardcopy and electronic documentation and archiving system for consent forms.• Initiated and implemented the weekly meetings with 28 field data specialist (Site Quality Assurance) overseeing participant recruitment to review data uploads, and sample collection thereby reducing errors and data rejection by 25% saving over $1900 in recruitments costs on incomplete data.• Collaborated with HR and Director of Quality to optimize the interview/recruitment and onboarding/training process for new site teams improving the quality of personnel on site teams which directly translated to improved data quality by 20%.• Oversaw employee training and development for 14 new recruits over a 6-month period, offering continuous advice, guidance and mentorship on duties and best practices. Show less

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  Hyde Engineering + Consulting

  Jan 2023 - now

  Cleaning Validation Specialist