San Francisco Bay Area
As a Quality Management Specialist at Paragon Genomics, I ensure the quality and compliance of our innovative products and services for next-generation sequencing. I have over 5 years of experience in the biotechnology industry, with a strong background in biochemistry and molecular biology. My core competencies include validation, cGMP practices, standard operating procedures, document control, training and compliance, internal auditing, process improvements, customer complaint investigations and trending, CAPA management, and ISO 9001:2015. I am passionate about delivering excellence and continuous improvement to our customers and stakeholders, and I strive to uphold the highest standards of quality and integrity in my work.
Managed QMS on FCDI satalite site in Novato, CA by performing mfg/QC batch reviews and dispositions, process and procedure audits, and maintaining site training and compliance program and equipment maintenance records.
FDA regulated facility that provides molecular and serological quality controls and standards to aid laboratories and blood centers in training and monitoring of commercial or in-house assays. - Quality tested infectious disease controls using qualitative and quantitative assays - Reviewed and released product lot batch records
• Used the Pharmacy Information Management System (PIMS) to access and process new or filled patient prescriptions for sale • Tracked dropped off patient prescriptions to ensure timely sale of medication