Loubaron Zolina
Quality Associate Ii @Bionano
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WORK HISTORY
Quality Associate Ii @Bionano
Participates in the implementation, development, management and integration of the Bionano Genomics QMS. • Run Document Control activities including creation and/or revision of documents, processing, routing and review, and holding Change Control Board meetings as needed. • Participate in the design, release and implementation of documentation for process control, process improvement, inspection and test. • Participate in internal and external quality audits. • Manage and maintain quality records. • Review of batch production records and analytical records for completeness and release to ensure compliance with cGMPs and Bionano policies and procedures. • Be well versed in the requirements of ISO 9001, ISO 13485, 21 CFR 820 and other applicable regulations. • Work with various departments to set up appropriate documentation to improve efficiency and accuracy. • Ensuring products tested adhere to established specifications and customer requirements for product release. • Recommending product disposition and updating records associated with products and incoming goods. • Labeling products and incoming goods with an appropriate status label after product disposition (e.g. Approved, Rejected, etc). • May be called upon to draft or revise documentation associated with the Incoming QC process, Document Control, or Batch Record Review. • Scanning, filing, and other document control related tasks. • Assist with internal Quality audits of internal departments, as necessary. • Assisting Quality Management with various projects, including but not limited to the trending of Quality Objective data and CAPA maintenance. • May be called upon to assist with the Supplier Qualification program for maintaining supplier documentation. • Provide guidance and train others on Quality System and Quality Assurance procedures. • Perform additional tasks, as assigned.
EDUCATION
University of San Francisco
Bachelor of Science (B.S.), Kinesiology and Exercise Science
SKILLS
ABOUT LOUBARON ZOLINA
With a passion and drive for the healthcare field since a young age and dedication to…
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