Xuanye Ma

Xuanye Ma-- PERSONAL PROFILE A meticulous and detail-oriented Quality Assurance Specialist with extensive experience in quality event management and compliance monitoring. Proven expertise in conducting thorough audits, overseeing quality control measures, and ensuring adherence to both company and regulatory standards. Demonstrated ability in addressing quality issues effectively, implementing corrective actions and preventive measures, particularly in customer-focused incidents. Worked in Fortune Global medical device for a year as a quality engineer familiar with drafting SOP, and basic understanding of ISO13485, GMP. Committed to maintaining the highest standards of quality assurance through a proactive and responsive approach, with a keen eye for identifying and fostering areas for development and enhancement. KEY ACHIEVEMENTS • • • • Organized deviation investigator qualification and enables over 40 people getting qualifications Established a rapid dual paper sensor diagnosing SARS-CoV-2 efficiently up to 20 copies/µL and IgG level in the acceptable range Co-author of Review of paper-based microfluidic analytical devices for in-field testing of pathogens published in Analytica Chimica Acta, doi.org/10.1016/j.aca- Hosted an exchange fair sharing my previous experience studying abroad and helped more than 20 freshmen adapt their life abroad EDUCATION Master by research in Biotechnology: Cranfield University, UK (Sep. 2021-Dec.2023) Individual project: a dual platform detecting SARS-Cov-2 virus and antibody in saliva samples on a paper-based device • Designed PCR and LAMP primers and probes using NCBI database, Primer 5.0 targeting ORF1a fragment of SARS-CoV-2 to establish the foundation of the experiment • Confirmed the sensitivity by utilizing RT-LAMP& RT-qPCR to ensure the limit of detection of saliva sample • Established immunoassay-like indirect ELISA protocol to detect antibodies against SARS-CoV-2 spike protein RBD • Studies paper capillary action, designed and wax-printed paper-based detection tool and optimized the microfluid flow process to interpret the outcome • Equipped experience with drafting Risk assessment and COSHH • Wrote a proposal about designing dCas-9 gene Circuit Modules: Introduction to python, Discovery of quality information, Research data management BSc (Honors) in Biological Sciences: Xi’an Jiaotong Liverpool University & University of Liverpool (Sep. 2016-June 2020) Modules: Biology of disease, Gene expression, and Genome analysis, Introduction to Statistics, Biotechnology, Protein Structure and Function, Cell Signaling, Methods for Analysing Public health, Organic Chemistry for Biologists, Biochemical Methods and Analysis, Calculus, Linear Algebra Individual Project: Fish Oil (FO) treatment for Prostate Cancer • Identified whether PDHA1 was a potential target if prostate cancer cells were treated with FO • The cultured PC3 cell line with different media and addition of FO, precited mammalian cell culture, manipulation, and maintenance • Downclocked the gene PDHA1 gene expression with siRNA transfection and used wester-blot to confirm its protein expression • Conducted MTT assay to measure cytoactive after FO treatment Membership: The head of External Communication of the Student Career Development Association (SCDA) Exchange program with the University of Leeds, UK (Sep. 2018-June 2019) Modules: Parasitology, Power of Bacterial Genomics, Medical Bacteriology, Genetic Engineering, Human Populations, Bio Membrane & Cell Signalling, Intermediate Skills for BioSci CAREER HISTORY & PROGRAM WuXi Vaccines (Suzhou Site) ---- QA Function Lead (May.2023-Present) • Regular quality data and quality events tracking and management with TrackWise • QA for QC review including data intergity, lab operation and monitoring OOS • Organized and participated deviation investigation training and acquired relevant qualification • Assist regular supplier, distributor qualification and management • Assist QMS with Master control system to be released • Liaise each department heads to generate Gap Analysis based on EU GMP Beckman Coulter Laboratory Systems Suzhou Co Ltd, Suzhou, CHINA –-- Quality Engineer (Aug. 2020June 2021) • Managed trending quality cases for IQ200 and iChemvelocity instruments to maintain the acceptable safety level of biological machines following ISO13485 • Assisted complaint handling unit (CHU) by troubleshooting the machine using root cause analysis and QMS standards to eliminate the occurrence of repetitive cases • Proposed an open communication channel to line managers by presenting a benefit/loss analysis (SWOT) to increase employee engagement and team bonding. • Participated in valve CAPA investigation Institute Pasteur of Shanghai Chinese Academy of Sciences: Shanghai, CHINA---- Lab Assistant (Jun. 2019-Aug. 2019) • Gained experience working in a BSL-3 aseptic environment • Facilitated the lead researcher by organizing a sheet of 80 types of cancers and viral cells with ATTC standards to improve the search efficiency in the group • Performed PCR and electrophoresis, gel extraction, and sequencing to confirm a fragment of the virus • Practiced LLC-MK2 cell culture • Completed an entire process of transfection experiment by transfecting LLC-MK2 cell with VR 167 to demonstrate virus features. ACTIVITIES Common scientific book writing: Food system in CHINA ----- Associate Writer (20th March -December， 2022) • Being responsible for the writing on Amazon rain forest soil implementation impacts on Greenhouse Gas emission (GHGS) and ultra-food production process. Managed to link the global issue to CHINA status • Hold the weekly meeting allowing participants to share ideas and promote the wiring process 4Th EbNET Environmental Biotechnology Conference, Nottingham, UK----Presenter (12nd Sept.-14th Sept 2022) • Presented by current work in an academic poster format and made people aware of the potential use of saliva • Exchanged internal dynamics in biotechnology fields and built a robust social network with other researchers SKILLS Professional: DNA cloning, site-directed mutagenesis, qPCR, RT-LAMP, ELISA, ELISpot, primer and probe design, DNA& RNA extraction and purification, cell culturing, SDS-PAGE, Western blot, gel electrophoresis, gene interfering, protein expression quantification, clinical sample treatment, antibiotic resistance assay, technical troubleshooting and data analysis Language: Mandarin (Native speaker), English (Advanced) IT skills: Confident IT user with Office Software, Pubmed, Latex (Basic), Python (basic), Image J, CorelDRAW, GraphPad Prism9, Obsidian Communication: Excellent ability in presentation and cross-function communication