Wendy Levine

About Wendy Levine

In the quest for new professional opportunities, I am poised to capitalize on my proven track record in the domains of Training and Quality Assurance while simultaneously exploring avenues within the field of Psychedelics. I have garnered recognition in the field of Training for creating modular Training Curricula, thereby greatly reducing each employee’s Training burden, and have also developed Training programs and presentations that cultivate learning and foster growth and development. However, my professional journey doesn\'t end there. Alongside my proficiency in Training, I bring a wealth of experience in Quality Assurance, adding multiple layers of versatility to my skill set. This diverse background has equipped me with a keen eye for detail, a knack for problem solving and a dedication to ensuring Quality Management System excellence. Currently, my career aspirations extend beyond traditional realms. I am drawn to the rapidly expanding field of Psychedelics, captivated by the potential these substances hold in revolutionizing mental health treatment. My ambition is to contribute to this transformative space, supporting the development of innovative therapies that address unmet mental health needs and offer hope to those who have long sought relief. In summary, I am seeking a role that not only aligns with my current expertise in Training and Quality Assurance but also allows me to pursue my new interest in pioneering advancements in mental health through the realm of Psychedelics. I am excited about the prospect of finding a position where I can merge my skills, experience, and aspirations to make a meaningful impact in the world. PAST LIFE: My prior career was in the Genomics industry where I worked as Production Manager & Process Development Manager. I developed cutting edge technologies in high-throughput genome sequencing, gene synthesis and genotyping. SPECIALTIES: Medical Devices, In Vitro Diagnostics (IVD), Biotechnology, Life Sciences Training Development, Training Presentation, Training Management Quality Assurance, Quality Engineering, Manufacturing Quality System establishment and improvement. FDA regulations, 21 CFR 820, ISO 13485 Internal/Supplier Auditing, Lead Auditor, External Audits Corrective and Preventive Actions, Root Cause Analysis Document Control, SOPs, Procedures, Work Instructions Design Control, Risk Management Certified Quality Engineer Psychedelics

Experience

1. Principal Design Quality Specialist

   Roche Sequencing Usa

   Mar 2021 — Present · Santa Clara, CA, US

   Supported the development of Next Generation Sequencing In Vitro Diagnostic products and Laboratory Developed Tests as core team Design Quality Lead; provided collaborative, solution-oriented technical guidance and support.* Participated in Design Verification, Validation and Process Validation planning, protocol review and report writing.* Performed design change control activities including impact assessments, risk management and design transfer.* Led difficult discussions challenging legacy ways and identifying mutually beneficial compromises.

Education

• Indiana University Bloomington

  B.S., Biology

• The Ohio State University

  Doctor of Philosophy - PhD, Molecular, Cellular and Developmental Biology