Control Analyst Research Associate

Ada Li - (***)***/**** - California/Washington Greater Area

Education: B.S. Biochemistry and Molecular Biology, U.C. Davis 7 years of cGMP experience in technology transfer, quality control, quality assurance, development and manufacturing roles pertaining to operations, techniques and equipment used in standard manufacturing and biologics platforms from API to bulking, filling, lyophilization and packaging/labeling.

● Participated in tracking process parameters for upstream processing and prepared data analysis for audits using Excel

● Technical writing for deviations, CAPAs, SOPs using word and Trackwise

● Experience with several enterprise document and quality management systems

● Performed batch record review using IQS and executed steps using MES (work orders, routing documents)

● Data analysis using several software systems such as mySQL

● NGS manual feasibility for onboarding onto automation

Automation with Hamiltion, Tecan, QPix, Echo, Mantis for high throughput miniprep, transformation, qPCR/PCR, competent cell preparation

Gilead (Actalent), Foster City CA July 2021 – May 2022 /QAAssociate, Commercial API

● Verify, route and review documents to support annual site qualification for contract manufacturing organizations using VeevaVault.

● Initiate and perform draft write up for contract manufacturing organization deviation events using Trackwise.

● Batch record review for contract manufacturing organizations. Roche Sequencing Solutions (Contract Position), San Jose CA December 2020 – March 2021/Scientist II

● Development of Next Generation Sequencing (NGS) based workflows including library preparation, target enrichment, oligo quantification (Qubit, Tapestation, Spectramax) and sequencing through manual and automation studies. Biomarin Pharmaceutical Inc, Novato CA May 2019 - October 2020/ Senior QC Associate, QC Viral Vector

● Routine testing including pH, osmolality, cell culturing and training on HPLC. Zymergen (Contract Position), Emeryville CA September 2018 – March 2019 Research Associate

● Applying a broad range of analytical methods including PCR/qPCR, DNA gel electrophoresis, cloning/assembly, spectrophotometry, and other plate-based assays to QC and test engineered strains using various liquid handling automation techniques such as the Hamilton, Tecan, qPix, Mantis, Beckman, Echo platforms. Bayer Healthcare LLC, Berkeley CA

August 2016 – September 2018 Quality Control Analyst II, Potency

● Support global quality control site for reagent qualification and market release testing for recombinant factor VIII process steps from API to FPM (final product manufacturing).

● Identify protocol deviations/discrepancies and perform immediate investigations to determine root cause. File lab investigation reports and file change applications to prove equipment integrity after maintenance. Bayer Healthcare LLC, Berkeley CA

September 2015 – June 2016 Aseptic Processing Technician, Sterile Fill/Finish ● Perform routine COP of bulk tanks, pre and post filter integrity test, filler CIP and SIP, parts wash and autoclave of equipment in class A-F cleanroom environments using aseptic techniques.

● Make suggestions to the deviations team for CAPAs and root cause analysis to close deviations. Bayer Healthcare LLC, Berkeley CA

February 2015 – July 2015 Associate Scientist, Capacity Expansion Biologics: API Technology Transfer ● Perform reviews for manufacturing process documents and work with stakeholders for the alignment of standard operating procedures between sending and receiving Bayer sites.

Bayer Healthcare LLC, Berkeley CA

August 2014 – February 2015 Data Collection Associate, FDA Observation 1 Team ● Perform data queries and functions in MES, LIMS, SAP, SCORE in order to review, verify, validate past manufacturing, packaging, QC and QA documentation records such as BPRs (batch production records) and EBRs (electronic execute batch records). Critical process parameter deviations are communicated to QA for correction or investigation.

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