Hi, I’m
Aušrinė Šimkienė
Quality Assurance Specialist
Vilnius,Vilniaus Apskritis
Summary
Detail-oriented team player with strong organizational and communication skills. Ability to handle multiple projects simultaneously with a high degree of accuracy. Excellent problem solving skills. Able to demonstrated a good knowledge of medical terminology GCP and GMP requirements. Strong background in collecting and analyzing quality measures and making recommendations for process and quality improvements. Overall hardworking and passionate about clinical research and improving quality of life for patients.
Overview
17
years of professional experience
9
years of post-secondary education
5
Certifications
3
Languages
Work History
Thermofisher Scientific
Quality Assurance Specialist
2021.06 - Current (5 education.years_Label)
Job overview
- Optimized workflow efficiency by introducing automation tools into QA process where appropriate.
- Reduced costs associated with rework by applying PPI methods: GEMBA walks, Kaizen projects, 5S and etc.
- Utilized root cause analysis techniques (TrackWise) to identify underlying issues contributing to product defects or customer complaints.
- Ensured product compliance with ISO 9000, ISO 13485, Eudralex Volume 4, ICQ Q7, FDA regulations by staying up-to-date on standards and guidelines, implementing necessary changes to maintain conformance.
- Improved product quality by implementing rigorous testing procedures and identifying areas for improvement.
- Mentored junior QA specialists, fostering culture of continuous learning and professional growth.
- Document management (Master Control); Development, revision and implementation of Standard Operating Procedures;
- Participation in audits, risk assessment management, change control and validation processes;
- Promoted culture of continuous improvement within organization by leading GMP training sessions on various aspects of quality assurance
- Streamlined documentation process, ensuring adherence to industry standards and regulatory requirements
- Reduced costs associated with rework by improving inspection processes throughout entire production line
- Collaborated with cross-functional teams to develop robust quality assurance strategies for new products
- Fixed identified issues to increase productivity and boost workflows
- Educated employees on specific QA standards and confirmed maintenance of standards
King's College Hospital
Biomedical Scientist-Stem Cells Laboratory
2019.06 - 2021.05 (1 education.year_Label & 11 education.months_Label)
Job overview
- Handling of stem cell products (pluripotent stem cells, bone marrow and ATMP's) in laboratory safely and accurately
- Quality testing of stem cell samples to ensure safe and efficient treatment for patients.
- Processing Stem cell products according to GMP requirements.
- Working with lab management software including WinPath and Q-Pulse.
- Maintaining and running specialist lab equipment
- Executing accurate and timely record keeping and data management for each test undertaken
- Participation clinical trials: preparation of ATMP's products for transplantation process, supervising transplantation process in clinical premises ensuring patients safety and processes performance according to quality requirements.
- Responding to enquiries from clinicians regarding test results on phone and in person
- Training and supervising trainee and Band 5 Biomedical Scientists
- Collaborated with cross-functional teams to achieve best patient care.
West Hertfordshire NHS Trust
Specialist Biomedical Scientist (Band 6)
2014.06 - 2019.05 (4 education.years_Label & 11 education.months_Label)
Job overview
- Handling, processing and analyzing range of blood samples in laboratory safely and accurately
- Screening and testing samples to help in diagnosis and treatment of range of hematology malignancies including Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia, Hodgkin's lymphoma, multiple myeloma etc. and other blood abnormalities such as anemia, hemoglobinopathy, blood parasites like Malaria.
- Identifying abnormal blood cells by applying microscopy diagnostic method.
- Working with lab management software including WinPath and Q-Pulse.
- Maintaining and running specialist lab equipment
- Developing lab's quality management system and ensuring that ISO15189 requirements are met
- Executing accurate and timely record keeping and data management for each test undertaken
- Evaluate and authorize test results
- Responding to enquiries from clinicians regarding test results on phone and in person
- Training and supervising trainee and Band 5 Biomedical Scientists
- Balancing standard daily test booking alongside urgent requests from ICU or A&E
- Collaborated with cross-functional teams to achieve best patient care.
West Hertfordshire NHS Trust
Biomedical Scientis - Band 5 (Haematology )
2012.10 - 2014.06 (1 education.year_Label & 8 education.months_Label)
Job overview
- Presented final project study results at International Biomedical Science congress, fostering professional networks and promoting knowledge exchange.
- Conducting and processing over 500 tests on range of blood samples from patients per day
- Inputting samples and data into LIMS ensuring fast and accurate results delivery to clinicians
- Researching and developing new methods of investigation and diagnostic innovation
- Collaborated with interdisciplinary teams to improve patient outcomes and advance healthcare solutions.
- Prioritizing workload to manage routine and urgent testing request in same day
- Delivering results to clinicians in person, maintaining high standards of patient confidentiality
- Identifying abnormal or unexpected results and reporting to clinicians in prompt manner
- Reduced error rates in data analysis by maintaining daily quality and maintenance to ensure accuracy and reliability of results.
- Streamlined lab workflows by implementing Lean Six Sigma principles, reducing waste while maintaining high-quality outcomes.
- Identified areas for improvement in existing processes through regular audits, increasing overall lab productivity.
- Trained new employees on areas of technical expertise and compliance issues relevant to lab setting.
- Performed complex troubleshooting and assisted in leading initiatives to solve challenging scientific problems with assays or instrumentation.
- Followed strict safety protocols, while carrying out technical procedures and protocols.
- Consulted with clinicians to analyze problems, recommend technology-based solutions.
- Executed high-quality test analysis using equipment such as flow cytometers, HPLC analyzers and advanced microscopy systems like immunofluorescence.
- Mentored junior Biomedical scientists, providing guidance on test analysis, data analysis, and career development opportunities
West Hertfordshire NHS Trust
Biomedical Scientist Trainee-University Placement
2008.09 - 2012.09 (4 education.years_Label)
Job overview
- Conducting the supervised testing of blood samples in an accurate, timely and efficient manner
- Carring out supervised lab procedures in different areas of the laboratory (Haematology, Coagulation, Blood Transfusion, Immunology, Haemoglobinopathies)
- Supporting the Madical Lab Assistants in theri supply and inventory management procedures
- Managing safety checks and maintaining cleaning standards for laboratory equipmwnt
- Handling samples correctly and in line with laboratory health ans safety standards
- Maintained up-to-date knowledge of emerging trends in biomedical science, ensuring relevance in research design and methodology.
- Optimized laboratory protocols for increased accuracy, reproducibility, and overall effectiveness in experiments.
- Reduced error rates in data analysis by maintaining meticulous records and utilizing advanced software tools.
Buckinghamshire NHS Trust
Medical Laboratory Assistant - Microbiology
2007.06 - 2008.08 (1 education.year_Label & 2 education.months_Label)
Job overview
- Managed over 100 microbiology samples per day
- Supported Biomedical Scientists by preparing samples for testing
- Managed cleaning stock, performing regular and thorough sterilization procedures, operated autoclave
- Facilitated communication between medical staff and laboratory personnel for efficient result delivery and collaboration
- Managing and maintaining laboratory stock, by optimizing inventory management systems for necessary supplies, preventing shortages or delays in testing capabilities
- Increased lab productivity by effectively prioritizing tasks and completing them within designated timeframes
- Maintained clean, safe work environment by following strict laboratory protocols and guidelines
Education
Vytautas Magnus UniversityKaunas
Master of Science from Molecular Biology And Biotechnology
2020.09 - 2023.06 (2 education.years_Label & 9 education.months_Label)
University of WestminsterLondon
Bachelor of Science from Applied Biomedical Science
2008.10 - 2012.06 (3 education.years_Label & 8 education.months_Label)
Vilniaus Higher Education InstitutionVilnius
Associate of Science from Biomedical Laboratory Technician
2002.10 - 2005.06 (2 education.years_Label & 8 education.months_Label)
Skills
Quality Assurance
Communication Skills
Non-compliance Assessments
Knowledge of ISO, ICH, GMP, GCP regulations
Performance monitoring
Documentation And Reporting
Quality Assurance
Certification
HCPC Biomedical Science License, The Health and Care Professions Council
Availability
See my work availability
Not Available
Available
monday
tuesday
wednesday
thursday
friday
saturday
sunday
morning
afternoon
evening
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Timeline
Media Fill and Sterility, Global Quality Solutions
2022-09
Quality Assurance Specialist
Thermofisher Scientific
2021.06 - Current (5 education.years_Label)
Vytautas Magnus University
Master of Science from Molecular Biology And Biotechnology
2020.09 - 2023.06 (2 education.years_Label & 9 education.months_Label)
CAR-T cell, European society for Blood and Marrow Transplantation (EBMT)
2020-01
Good Manufacturing Practice (GMP), King’s Health Partners
2019-08
Biomedical Scientist-Stem Cells Laboratory
King's College Hospital
2019.06 - 2021.05 (1 education.year_Label & 11 education.months_Label)
Specialist Biomedical Scientist (Band 6)
West Hertfordshire NHS Trust
2014.06 - 2019.05 (4 education.years_Label & 11 education.months_Label)
Biomedical Scientis - Band 5 (Haematology )
West Hertfordshire NHS Trust
2012.10 - 2014.06 (1 education.year_Label & 8 education.months_Label)
HCPC Biomedical Science License, The Health and Care Professions Council
2012-06
IBMS Certificate of Competency in Biomedical Science, Institute of Biomedical Science (IBMS)
2012-06
University of Westminster
Bachelor of Science from Applied Biomedical Science
2008.10 - 2012.06 (3 education.years_Label & 8 education.months_Label)
Biomedical Scientist Trainee-University Placement
West Hertfordshire NHS Trust
2008.09 - 2012.09 (4 education.years_Label)
Medical Laboratory Assistant - Microbiology
Buckinghamshire NHS Trust
2007.06 - 2008.08 (1 education.year_Label & 2 education.months_Label)
Vilniaus Higher Education Institution
Associate of Science from Biomedical Laboratory Technician
2002.10 - 2005.06 (2 education.years_Label & 8 education.months_Label)