Quality Assurance Manager

• Feb 2022 - Present

Commercial API Quality Assurance Specialist

• Jan 2018 - Feb 2022

Commercial Analytical Operations - Associate

• Apr 2017 - Dec 2017

• Work with my team to review Certificates of Analysis (CoAs) received from Contract Manufacturing Organizations (CMOs) to assure proper lab testing was done on API, DP, or Clinical Product, and that results fall within Gilead and CMO specs• Input results into the Gilead Laboratory Inventory Management System (GLIMS) to allow Gilead to produce in-house CoAs• Review colleagues’ entries, to facilitate internal QA departments to process CoAs in a timely manner • Train newly hired colleagues with our day to day processes• Run trends in GLIMS to determine any discrepancies in our group’s workflow Show less

QA Associate

• May 2016 - Mar 2017

As a Quality Assurance Associate, my duties include aiding my colleagues in releasing lots as they approve batch records. I ensure that the lots are released according to the correct expiration, retest dates, and the correct status. I also reconcile temptale data for our raw materials and API, ensuring there are no excursions in our shipments or lost data. I also input data into our GLIMS lab system, which in turn generates Certificates of Analysis for our shipments. The documentation of Master Batch Record Changes, CofAs, and all wet signatures are also part of my duties. When deviations arise in any situation, I also have experience in going into our GTrack system to start the deviation. Show less

Quality Specialist/Technical Services/Operations

• Jan 2015 - Apr 2016

Insure the documentation of irradiation runs are complete and accurate. I also dose map new customer products, meaning the validating of these new products so they can be run in our electron beam sterilizer. When needed, I routinely receive and ship customers' orders as they come in and get returned. I am also currently trained in operating the electron beam system itself, meaning I am responsible for controlling the dose each of our customers' products receive as they are put through our beam with precision. Show less

Laboratory Technician

• Jan 2013 - Jul 2014

Worked with a team to collect and sterilize glassware for the various Genentech buildings. Operated industrial washers, ovens, and autoclaves. Also made sure labware was stocked with the products needed for each labs' experiments. Worked with a team to collect and sterilize glassware for the various Genentech buildings. Operated industrial washers, ovens, and autoclaves. Also made sure labware was stocked with the products needed for each labs' experiments.

Laboratory Technician

• Dec 2008 - May 2009

Assisted in making buffers and gels for electrophoresis and maintained a clean work environment. Cleaned glassware and stocked lab manager's lab with various lab products. Assisted in making buffers and gels for electrophoresis and maintained a clean work environment. Cleaned glassware and stocked lab manager's lab with various lab products.