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Ruchika N

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Actively Looking for Full Time Roles | University of Michigan Master's in Medical Product Development | Biomedical Engineering | New Product Development | Qu...
California, United States

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Jobs verified_user 0% verified
  • Regeneron
    QA Validation Specialist
    Regeneron
    Jun 2024 - Current (2 years 4 months)
    Manage Document Management System (DMS) workflows, review/approve post-execution procedures, and ensure compliance with site QMS and regulatory standards. Review, approve, and close calibration and maintenance work orders with Metrology/Instrumentation teams; ensure adherence to SOPs, site standards, and regulatory guidelines. Generate and assess Out of Tolerance (OOT) records, conduct impact analyses, document risk assessments, and ensure timely closure in compliance with quality metrics. Support internal and external audits by preparing calibration, maintenance, and OOT documentation; ensure readiness for ISO 13485, ISO 9001, and FDA inspections. Compile and monitor monthly workload assignments and service level agreements (SLAs), reporti
  • I
    Medical Data Analyst
    ImmiHealth
    Jul 2023 - Jul 2024 (1 year 1 month)
  • University of Michigan
    Product Developer- Cool Limb
    University of Michigan
    Aug 2021 - Apr 2022 (9 months)
    • Surveyed clinical needs and developed a working prototype of a cooling prosthetic liner as a team of 5.
    • Communicated and collaborated with teammates and used Solidworks to model and 3D printed molds.
    • Surveyed, researched, and developed a business plan for the brand to improve customer reach and make it accessible.
    • Performed various Verification and Validation tests to ensure the product met its design specifications and intended use.
  • S
    Engineer Intern
    Sphaera Pharma
    Jul 2019 - Oct 2019 (4 months)
    • Ensured appropriate regulations, such as 21 CFR Part 11, 210/211and cGxP regulatory compliance as addressed in validation.
    • Performed FDA-based customized systems validation for the intended use and environment of the system.
    • Developed and reviewed Validation documents and test scripts using Kneat.
    • Conducted feasibility studies to estimate product cost and analyze capital equipment, capacity, and capability requirements.
    • Create a validation document (GxP risk assessment, verification and validation plan, test scripts, and IQ/OQ/PQ protocols, etc.) for the Risk Evaluation & Mitigation Strategy (REMS) project.
    • Learned about aseptic manufacturing and GAMP 4 & 5 processes.
  • Amity University
    Research Assistant
    Amity University
    Jan 2018 - Jul 2018 (7 months)
    • Developed a Biosensor for the detection of Organophosphate chemical in pesticides.
    • This project was funded by IARI, the most prestigious and topmost agricultural research institute of India.
    • Developed wet laboratory skill set such as preparation of phosphate buffers, and cyclic voltammetery and prepared various concentrations for growing various samples of Solanum lycopersicum.
    • Presented a Poster also at an agricultural symposium at New Delhi and placed 2nd in the competition.
Education verified_user 0% verified
  • Amity University
    bachelor, Bachelor of Technology - BTech, Nanotechnology
    Amity University
  • U
    master, Master of Science - MS, ENGINEERING
    University of Michigan Biomedical Engineering
  • University of Michigan
    master, Master's degree
    University of Michigan
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