Experience

Megazyme

• Ireland
• Biotechnology Research
• 1 - 100 Employee

• Quality Manager

  • Jan 2022 - Present

  Responsible for implementing and maintaining site quality management system to maintain compliance and drive improvement within the business. Quality activities include:-Quality documentation-Document control -CAPA Management -Supplier review -Asset management -Internal audits-Training and competency -Management reviews and trending -Change control and change management -maintain certification and manage external audits-manage complaint investigations and draft customer communications when required-Trend data monthly and report company performance, KPIs and analysis data for trends Show less

• Quality Assurance Specialist/Team Lead

  • Jul 2021 - Jan 2022

  1. Reporting to the Head of Quality & Compliance (Neogen Europe), be responsible for ensuring quality activities meet with organisational requirements. 2. Monitor, measure and report on quality issues, opportunities and risks within agreed formats and timescales.3. Create and implement electronic quality management system in the Bray site Q-Pulse where CAPAs, documents, training, suppliers, audits and assets are managed. 4. Issue, review and approval of QMS documentation, including protocols, specifications, workbooks, SOPs, validation protocols, and all other QMS documentation.5. Perform and maintain effective control of core site activities of the QMS including Non-conformance reporting, Investigations, Complaints and Internal audit/inspections.6. Champion a continuous improvement culture and direct the change control process.7. Control and maintenance of QPulse quality management system. Maintain KPIs from QPulse activities on a monthly basis.8. Analyse data to identify areas for improvement in the quality system.9. Perform Quality and QPulse training and support.10. Implementing and maintaining a Quality Risk Management system to ensure that risks are adequately controlled. 11. Ensuring that the supplier and subcontractor audits are performed and reported as scheduled.12. Control the preparation and facilitation of client/regulatory audits.13. Manage and maintain certification to ISO9001:201514. Controlling archiving of Quality & Technical records.15. Perform weekly meetings with operations managers to ensure conformity to the QMS16. Perform monthly and annual management reviews and present to top management. Show less

• QC Specialist/Team Leader

  • Dec 2019 - Jul 2021

  -Responsible for day to day running of lab-Training new laboratory staff across the business-Performance reviews-Delegation of lab activities-Review analysis results weekly for release to stock-Create product documentation -COA/data sheets-Record and report lab metrics on a weekly basis-Provide technical support to customers

• Senior Quality Control Analyst

  • Feb 2018 - Dec 2019

  • Responsible for staff training within the lab• Delegation of laboratory tasks• Weekly reporting of lab performance to senior management• Size exclusion chromatography• Review and streamline laboratory processes• Review, update and write laboratory SOP's• Answering customer queries regarding products, assay performance, complaints and troubleshooting• Perform laboratory troubleshooting assays • Weekly review of staff QC reports and approve for product release to stock• Responsible for contract analytical services for external companies-pricing, invoice request, analysis, reporting and submission of results• Laboratory analysis - biochemical assays, enzyme activity assays, product purification and carbohydrate determination assays• Act as support for laboratory manager and laboratory staff• Internal auditor - ISO:9001 2015• Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs)• Maintenance of laboratory equipment and chemicals• Trending of lab data and results Show less

• Quality Control/Biochemical Analyst

  • Feb 2016 - Feb 2018

  I am a biochemical/quality control analyst at Megazyme International. Megazyme is a global leader in the development of analytical kits and enzymes for the food, wine and agricultural feed industry. My duties include:• QC on existing and new products• Assay Validation• Assistance with research and optimisation of new products• Stability scheduling and testing• Answering of customer queries regarding assays, experiment design and troubleshooting• Perform analysis as part of the contract laboratory service• Protein Concentration• pH, Osmolality, Viscosity, and Appearance• Size exclusion chromatography• Assist manager and team in the design and set-up of the QC laboratory and selection/ implementation and calibration of laboratory instruments.• Gas chromatography• Spectrophotometry• Write new and update current SOPs as needed• Provide training to other analysts in the QC group• Analytical data reporting • Enzymatic activity analysis• Ensure that all work carried out is in compliance with the required regulatory standards, conforms to company policies and standard operating procedures (SOPs)• Maintenance of laboratory equipment and chemicals Show less



Randox Testing Services

• United Kingdom
• Hospitals and Health Care
• 1 - 100 Employee

• Research Scientist

  • Feb 2015 - Feb 2016

  • Performing immunoassays on a daily basis using the Randox Biochip Array Technology and ELISAs • Preparation of analytical plans for new research studies • Performing assay validation • Use of the Sysmex Haematology Analyser and Roche Urisys to analyse patient samples • Writing SOP’s for lab processes using Q-Pulse • Keeping up to date with current SOP’s and creating new SOP’s for new laboratory processes • Use of Clinical Chemistry Analysers such as the RX Imola and RX Daytona + for clinical diagnostic testing • The preparation and handling of samples and diagnostic reagents • The accurate maintenance of analytical records • Troubleshooting any assay/QC/analyser issues • Strict adherence to chain of custody procedures throughout the analytical process • The routine maintenance and calibration of analytical instrumentation • The adherence to Company Health & Safety procedures and the maintenance of a safe working environment • Performing daily calibrations and quality control checks and interpreting, analysing and trending the results • Routine use of the Randox Testing Services Laboratory Information Management System (LIMs) • The interpretation and reporting of analytical data Show less