Chloe Mc Aleer
South Yarra
Summary
Methodical Quality Control Analyst skilled in developing protocols to positively impact manufacturing quality. Practiced at completing exhaustive tests of incoming materials, components and finished products. Proven experience within Medical Device industry performing direct hands-on work in QA and QC functions with strong familiarity of general practices,ISO 13485 and MDSAP requirements.
Overview
11
11
years of professional experience
Work History
Quality Assurance Associate
4DMedical
07.2024 - 03.2025
- Responsible for the administration, preparation, execution, maintenance, submission and tracking of quality assurance documents and files
- Raising, coordinating and processing change controls and non-conformances
- Supplier management which included assessing, auditing, and approving new suppliers
- Primary document controller for the business
- Supported continuous improvement efforts by actively participating in process reviews and suggesting data-driven recommendations for enhancement.
- Communicated effectively with suppliers to address any discrepancies found during incoming material inspections, fostering strong working relationships and better supply chain management.
- Collaborated with managers to write procedures for Software, Regulatory, Product and Customer Solutions departments.
- Educated employees on specific QA standards and confirmed maintenance of standards.
- Documented and executed detailed test plans and test cases and summarized and logged audit findings for reporting purposes.
- Assisted with independent internal and external audits.
- Supported audit preparation through research, analysis and presentation development.
- Assisted in the development of training materials, boosting employee understanding of quality standards and expectations.
- Developed and implemented procedures to meet product quality standards.
- Reviewed production processes and identified potential quality issues.
- Drafted technical documents such as testing protocol and trend analyses.
Production Technician
4DMedical
04.2023 - 07.2024
- Mechanical Assembly of 2 X-Ray Scanners for clinical trial
- Set up of the manufacturing facility to include manufacturing areas, segregated R&D areas for D&D work, incoming goods inspection bay and inventory management.
- CSV and implementation of an ERP system
- Trained new team members on equipment operation, safety protocols, and company policies, fostering a skilled workforce.
- Assisted in quality control measures by performing routine inspections of products against established standards.
- Performed regular calibration checks on instruments ensuring precision measurements throughout the production process.
- Promptly documented and reported all defective equipment and hazardous conditions.
- Monitored inventory levels, ensuring adequate stock of raw materials and consumables for uninterrupted production operations.
- Improved product quality by implementing rigorous quality control checks at various production stages.
- Implementation of daily manufacturing meetings to track manufacturing progress and to ensure NC tasks were closed out in a timely manner
- Responsible for all incoming goods tasks including inspection and any related non-conformance tasks
Production Scientist Team Lead
Beckmann Coulter
08.2022 - 01.2023
- Formulation of Analyte solutions in large batch scale following a BOM
- Operation of impregnation machines required for the manufacture of Slit Rolls for urinary analysis test strips according to agreed schedule
- BHR generation, reviewing and booking
- Raw material and WIP management to improve cost reductions using Oracle
- Delegate shift tasks daily and for department supervisor when required
- Conducted routine maintenance on laboratory equipment to ensure optimal performance.
- Collaborated with cross-functional teams to troubleshoot issues and improve overall productivity.
- Enhanced product yield by implementing innovative production techniques and strategies.
- Communicated effectively with team members, fostering a positive working environment conducive to collaboration and problem solving.
- Trained new team members on lab procedures, ensuring consistency and accuracy in their work.
- Maintained detailed records of all experiments performed, results obtained, and conclusions drawn, ensuring accurate documentation and easy reference for future projects.
- Managed inventory of raw materials, ensuring availability for uninterrupted production activities.
- Participated in regular meetings with management to discuss progress, challenges, and plans for future projects.
LIMS Technician and QA/QC Technician
Johnson & Johnson Vision Care
10.2019 - 07.2022
- Weekly rundown of the LIMS issue tracker and presentation of results on a graph
- Assist LIMS engineers in completing UAT/PQ testing when required
- Audit Trails for base business and combinations plant
- Product inspection and testing following laboratory procedures and standards
- Collation and entry of results into LIMS
- Recording of results as per good documentation practices
- Performed troubleshooting and diagnosis on malfunctioning equipment.
- Document review
- Trained new technicians on standard operating procedures, ensuring consistency across the team.
- Fostered culture of continuous improvement, encouraging innovation and efficiency in technical processes.
- Streamlined communication, introducing centralized platform for logging and tracking technical issues including the LIMS tracker for logging issues with batches.
- Enhanced team productivity with thorough training on new technologies and procedures.
- Tested systems, noting issues and completing preventive maintenance.
- Inspected, evaluated and calibrated electrical and mechanical systems and components.
- Liaised with internal departments to optimize productivity and efficiency.
Quality Administrator
Reagecon Diagnostics
03.2019 - 10.2019
- Implementation of accredited test methods, production of high-quality standards in accordance with SOP’s, ordering of materials for internal and external customers
- Gap Analysis of current and superseded ISO 17025 to update their accreditation status
- Managed the calibration and maintenance of critical equipment to ensure accurate measurements throughout the manufacturing process.
- Assisted in achieving ISO certification by developing comprehensive documentation outlining company-wide quality management systems.
- Managed and archived quality documentation and participated in internal and external quality audits.
Machine Operator
Molex Ireland
07.2014 - 12.2018
- General maintenance and running of assembly machine
- Inspection of raw materials and final production
- Use of SAP to maintain current levels of inventory
- Followed detailed instructions to operate machines with accuracy and produce quality products.
- Set up and adjusted equipment and properly configured machines for daily operation.
- Complied with company and OSHA safety rules and regulations.
- Loaded raw materials into machines and unloaded finished products to keep manufacturing process running smoothly.
- Set up and ran machinery to produce exceptional products for industrial needs.
- Streamlined workflow by maintaining a clean and organized workstation, adhering to safety protocols.
- Calibrated, tested, and adjusted machine settings or controls in preparation for production operations.
Education
Post Graduate Diploma - Advanced Biopharmaceutical Science
Atlantic Technical University
Galway, Ireland05.2022
Bachelor of Science - Applied Biology and Biopharmaceutical Science
Galway-Mayo Institute of Technology
Galway, Ireland05.2019
Skills
- Extensive Experience with Microsoft Office
- Thorough Data Documentation
- Systematic Documentation Techniques
- Supporting Staff Development
- GMP Compliance Expertise
- Proficient Technical Writer
- Regulatory Compliance Expertise
- Licensed Forklift Driver
- ISO Compliance Knowledge
- User acceptance testing
- Validation techniques
- Six sigma methodologies
- Batch production records
Timeline
Quality Assurance Associate
4DMedical
07.2024 - 03.2025
Production Technician
4DMedical
04.2023 - 07.2024
Production Scientist Team Lead
Beckmann Coulter
08.2022 - 01.2023
LIMS Technician and QA/QC Technician
Johnson & Johnson Vision Care
10.2019 - 07.2022
Quality Administrator
Reagecon Diagnostics
03.2019 - 10.2019
Machine Operator
Molex Ireland
07.2014 - 12.2018
Post Graduate Diploma - Advanced Biopharmaceutical Science
Atlantic Technical University
Bachelor of Science - Applied Biology and Biopharmaceutical Science
Galway-Mayo Institute of Technology
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