Jayashree Shankavaram

About Jayashree Shankavaram

I am an accomplished results-driven Senior Software Quality Assurance professional with +15 years of experience in quality assurance, testing, compliance and verification & validation in FDA/CLIA regulated Medical Device and biotech companies. My specialty as principal SQA is to ensure that quality systems are implemented and maintained in a validated state ensuring that the GxP systems meet intended uses and comply with QMS, standards, applicable regulations, GDP and current industry practices.I do this by working collaboratively with cross-functional and technical teams to achieve productivity by partnering and promoting simplification, lean, problem-solving, change management, coaching & training and adoption, given my deep understanding and experience with Quality System Regulation, audits, risk, CAPA and change control.I have been successful because of my energetic, positive and open attitude, willingness to help and collaborate with teams. What’s unique about me and my approach is I practice what I preach. I constantly look for ways to improve and promote quality, apply feedback to improve performance; be influential and persuasive, an evangelist for patient safety, product quality and data integrity.SKILLSRegulations: ISO 13485, ISO 14971, IEC 62304, IEC 62366, 21 CFR Part 11 ER ES, 21 CFR Part 820, GAMP5, CSV, CSA Audits: ISO, FDA, CLIASuppliers: Supplier Assessments and re-evaluations, Supplier Corrective Actions (SCAR)Tools: ARIS BPM, Greenlight Guru eQMS, Testrail, Valgenesis VLMS, Jira, Confluence, CircleCi, HPQCApplications: Labbit LIMS, Salesforce, Siebel, SaaS, ERP j••••••••@gmail.com

Experience

1. Senior Software Quality Assurance Manager

   Linusbio

   Nov 2023 — Present

   Responsible for ensuring software quality for product and non product (commercial) from planning through development, verification and validation activities, release and maintenance.• Developed strategy, SOP and validation package for non-product commercial software (LIMS, ERP, SaaS) ensuring compliance with regulations with verifiable requirements, test plans, test reports and traceability.• Led validation efforts for LIMS and Salesforce releases. Ensured design is verified by testing and tracing.• Expert in managing multiple validation projects and vendor resources• Enabled commercialization of LDT IVD SaMD product having breakthrough device designation by FDA• Supported team to achieve CLIA certification in 49 states and to pass ISO 13485 certification• QA lead overseeing ordering portal integration with internal systems across 10 touchpoints • Conducted design review meetings and produced multiple artifacts (requirements, test plans, test reports, verification and validation) by directly collaborating with lab, engineering, data science, and service providers.• Mitigated product risk by implementing risk management process.• Improved quality and reliability by implementing a testcase management system• Utilize Agile practices to streamline processes and drive project success in dynamic, fast-paced settings LinusBio is a patient-centric, precision exposome medicine company headquartered in NewYork, NY. Originating from the world’s leading exposome laboratory at Mount Sinai HealthSystem, LinusBio has developed a technology platform that builds on breakthroughs inexposome sequencing.

Education

• The National Degree College Jayanagar

  Bachelor of Science - BS, Mathematics, Physics, Chemistry