Gordon Chen

About Gordon Chen

SummaryBiotech professional with over 18 years of experience in Quality Assurance, Research and Development, and Manufacturing.SkillsProfessional- Highly motivated and detail oriented- Strong individual and group skills- Takes initiative. Creative problem solver- Communicates honestly with managementQuality Assurance- Technical writing for SOPs, protocols, master batch records, forms, and master logbooks- Review of executed records, such as batch records, forms, logbooks, and change requests- Electronic quality systems: BMRAM (Blue Mountain Regulatory Asset Manager), TrackWise- Oversee proper implementation of Change ControlsManufacturing- Environments: GLP/GMP, clinical lab, R&D- Adheres to SOPs and performs tasks as instructed- Adheres to Good Documentation Practices when completing paperwork - Gowning in ISO 8, ISO 7 cleanrooms.Laboratory- DNA: MiniPrep/MaxiPrep, PCR, subcloning, restriction digest, mutagenesis, transfection, gel electrophoresis- RNA: Extraction, in vitro transcription, RNA Cleanup, transfection - Cell culture: mammalian, bacterial, aseptic technique, cell based assays- Machine operation: Illumina MiSeq, Applied Biosystems 7900 & ViiA7, Roche LightCycler 480- DNA sequence analysis: Sequencher, Vector NTIComputer- Windows and macOS- MS Office: Word (power user), Excel (power user), PowerPoint, Outlook, SharePoint- Excel: data analysis, graphs, vlookup, nesting formulas- Adobe Acrobat Pro and FoxIt PDF skills: forms/fields, headers/footers/watermarks, programming JavaScript- Admin for Box, Smartsheet, Wordpress- Creativity tools: Pixelmator, iMovie, GarageBand- Programming languages: JavaScript, C#, Unity Engine- Typing speed of 100+ WPM at >95% accuracy- SAP- LabWare7 LIMSMiscellaneous - Organize, lead, and closed many work projects- Comfortable in public speaking. Used to regularly participate in Toastmasters, a speech club- Teach Brazilian Jiu Jitsu, both in-person and remotely over ZoomCertificates- Six Sigma Green Belt- Coursera: Beginning Game Programming with C#

Experience

1. Qa Operations Associate Iii

   Pfizer

   Nov 2023 — Present · Bothell, WA, US

   Performs GMP duties within the Manufacturing Quality Assurance department- QA reviewer and approver for controlled documents such as master batch records and SOPs. Reviews for technical writing, overall formatting, and confirms process parameters are correct per Process Transfer Documents- Reviews and approves executed batch records, including solution, Cleaning-In-Place, upstream, downstream, and antibody conjugation batch records. Confirms Good Documentation Practices, calculations, asset and their calibration expiry, and reagent information expiry- Batch record reviews are performed either in office space or inside GMP suites (\"on the floor\").\"On the floor\" review ensures timely correction of documentation errors, timely guidance to manufacturing personnel, and quicker batch record review cycle time- QA reviewer for process deviations. Reviews for completeness, product impact, technical writing, and compliance before closing them- Dispositions direct raw materials, direct consumables, and direct parts: reviews warehouse paperwork, vendor certificate, and QC data, then releases material in Oracle Enterprise Resource Planning (ERP) database- Performs walkthroughs for Product Changeover (PCO) to ensure manufacturing suite only includes materials intended to produce desired product and free of materials intended for unrelated products.Projects- Gathers metrics for upper management - Quarterly metrics for Quality Review Management: Executed batch record Right First Time and Turnaround time- Monthly metric for deviation approvals within 5 business days - Use Excel to make helper tools to make compiling metrics easier- Updated department\'s SharePoint page- Created flowchart for troubleshooting leaks during manufacturing- Participated in testing test cases for Veeva quality systems transition

Education

• University of California, Berkeley

  BA, Molecular and Cell Biology

  2001 — 2005

• University of California, Berkeley

  Bachelor's degree, Cell/Cellular and Molecular Biology

  2001 — 2005

Skills

• User Requirements
• Cell
• Optical Alignment
• Data Analysis
• Imovie
• Gmp
• Cell Based Assays
• Xcode
• Adobe Creative Suite
• Research
• Transfection
• Unity3d
• Dna Extraction
• System Administration
• Rt-Pcr
• Tissue Culture
• Pharmaceuticals
• Pharmaceutical Industry
• Sop
• Box for Business
• Molecular Biology
• Smartsheets
• Game Design
• Site-Directed Mutagenesis
• Polymerase Chain Reaction (Pcr)
• Real-Time Polymerase Chain Reaction (Qpcr)
• Molecular Cloning
• Biochemistry
• Mobile Games
• Sharepoint
• Qpcr
• Javascript
• Ios Development
• Virology
• Pcr
• Biotechnology
• Protein Purification
• Game Development
• Purification
• Gel Electrophoresis