6+ years of experience in biotech and medical device manufacturing industry with Software Development Life Cycle, Software Implementation Life Cycle, Change Control Management and business Application Implementation Methodology (AIM).As a Senior Quality Specialist at Sera Prognostics, I am highly knowledgeable in all phases of software and computer system validation according to 21 CFR Part 11 and GxP FDA Regulations. I have adept knowledge of GLP, GCP GAMP V, cGMP, ICH, ISPE guidelines, especially in the areas of computer/software systems. Excellent attention to detail and experience in Good Documentation Practices by authoring and reviewing documentation such as: validation plan, risk assessment, specifications (FRS, URS), validation protocols IQ/OQ/PQ/DMQ/DRQ, validation summary report, SOPs, protocol deviation report (CAPAs), periodic reviews and internal audits.Experienced in validating Cots, SaaS and custom based applications such as MediaLab (Quality Management System), Cloudbyz, SalesForce and others.I have a bachelor's degree in Clinical Laboratory Science/Medical Technology/Technologist, and an associate's degree in Biomedical Sciences. I am certified as a Medical Laboratory Scientist by the American Society for Clinical Pathology, and as a Quality Improvement Associate by the ASQ. I am passionate about quality and software validation excellence, and I strive to continuously improve processes and systems through collaboration and innovation.