Roblie Vergara

Experience

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  University of California Berkeley Graduate School of Education

  Oct 2011 - Apr 2013

  Administrative Assistant III

  Hull Research Group- Supervised and delegated tasks to 5 work-study students- Updated and maintained 2 project websites: ecuc.info and hullresearchgroup.info- Assisted in completing federal reports and grant proposals- Commended by supervisor for assistance and resourcefulness in completing California Dept. of Education 21st Century grant proposal- Processed monthly federal program monitoring documents from 7 schools- Set up and coordinated interviews, notified candidates of hire and start dates, and coordinated orientation- Reconciled subaward invoices with GSE Business Services Office payments, uploaded and archived subcontractor reports- Recognized by GSE Business Services Office manager for correcting close-out subaward invoices- Completed PO/reimbursement requests and collect & review staff time sheets- Entered and verified data on youthservices.net, bSpace, and Google docs- Oversaw room reservations and took minutes during staff meetings- Sent out bi-weekly e-mail newsletters- Provided research assistance to graduate student researchers Show less

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  Life Technologies

  Apr 2013 - Apr 2014

  Associate Manufacturing Technician

  Contract position with Kelly Services- Worked in the oligonucleotide synthesis lab and learned about the chemistry behind solid-phase oligonucleotide synthesis

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  Thermo Fisher Scientific

  Jun 2014 - Jan 2018

  - Worked in a team based ISO13485 environment to manufacture high quality custom oligonucleotides/primers for use in the biotech industry- Contributed to the Ion AmpliSeq Exome project and Cancer Panel projects for New Product Introductions- Managed/trained 20+ operators in all stages of manufacturing, including: configuration, synthesis, QC, BRR, HPLC, PAGE, and final packaging- Received Bronze Level Award for displaying excellent leadership during a time when Manufacturing did not have a shift supervisor- Coded Crystal Reports and Business Intelligence Reports to investigate failures or to create visibility of orders or specific product lines in order to increase productivity- Regularly evaluated oligos throughout production, troubleshot issues, and made/pass fail decisions- Participated in Practical Process Improvement via Kaizen events, Root Cause Counter Measure meetings, PPI Meetings, CAPA assignments, and GEMBA walks.- Created/revised/obsoleted 30+ SOPs, WINs, and FRMs in Agile via DCOs- Reported out daily metrics and shift updates/pass-downs- Experienced with TrackWise System for generating/closing Problem Records (Complaints, Non-Conforming Material, Unplanned/Planned Deviations, CAPAs)- Analyzed QC results of oligos using Mass Spectrometry (LCMS) and Capillary Electrophoresis to verify identity/purity of oligonucleotides- Reviewed batch records to verify accuracy and ensure compliance with GDP- Collaborated with Engineering, R&D, QA, CS, and IT departments Technical SkillsAgile, SAP, E1, Trackwise, Microsoft Word, Excel, Powerpoint, Visio, JMP, C++, LIMs, KPIs, Crystal Reports, Business Intelligence, LCMS, CE, HPLC, PAGE, Tecan, Hamilton, Bravo, oligo synthesizers, microplate readers, pipettes, centrifuges, GDP, PPI, 5S, ISO 13485 Show less

  • Scientist I

    Aug 2017 - Jan 2018

  • Manufacturing Lead

    Mar 2016 - Aug 2017

  • Sr. Manufacturing Technician

    Jan 2015 - Mar 2016

  • Manufacturing Technician

    Jun 2014 - Dec 2014
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  Boehringer Ingelheim

  Jan 2018 - Jul 2021

  - Manage deviation investigations through timeline planning, scope determination, interviewing/consulting with affected parties and Subject Matter Experts, utilizing root cause analysis techniques, and summarizing findings in investigation reports- Present investigation findings for major deviations to Deviation/CAPA Review Board, client, and auditors- Closed 7 major deviations (including 5 client deviations) and 22 minor deviations within my first year- Generate metrics for manufacturing deviations/CAPAs and report data to manufacturing directors in bimonthly meetings- Support Continuous Improvement by identifying appropriate and effective CAPAs by utilizing lean manufacturing techniques- Utilize LIMS and DMS during investigations to review sample data and relevant procedures- Support management of manufacturing and engineering change controls - Awarded by Manufacturing Systems and Compliance Director and Plant Engineering Associate Director for initiating and getting approval for an urgent change control in record time: within one business day- Support junior level team members by providing guidance in decision-making and strategy- Identify and implement ideas to improve early closures of investigations- Support corporate, client, and FDA audits Show less - Led cross functional New Product Introduction (NPI) and operations teams to produce high quality GMP drug substance for human clinical trials in the single-use clinical manufacturing facility (Clinical Supply/Flextrain) - Planned and executed NPI and clinical manufacturing tasks, which include facility and personnel coordination, facility changeover and area release, receipt and release of CHO/murine cell banks, updating Bill of Materials (BOM), managing Process Orders (PO), batch record release/issuance and initiation of NPI change controls- Owned change controls and supported execution for the qualification of new equipment- Authored/Revised batch records, SOPs, User Requirement Specifications (URS), validation protocols/reports, test cases, technical memos, discrepancies, and Turnover Packages (TOP)- Executed study protocols for CAPAs or continuous improvement/process development- Identified process deviations and performed deviation investigations, implemented CAPAs and effectiveness checks and closed all deviations on time by utilizing open communication and collaboration with Plant QA- Supported Quality Systems with completing equipment Data Integrity (DI) Risk/Gap Assessments and actively supported the implementation of DI remediation projects- Supported Upstream seed train GMP operations from ampoule thaw and wave operations to the production stage bioreactor and harvest operations through verification of calculations for passaging/transfer of cells to the next stage, performing hands-on operations on the floor, assisting in MES operations - Contributed to operation’s lessons learned by implementing GDP errors tracker and presenting errors to the team- Ensured compliance within Clinical Supply through GMP walkthroughs, changeovers, monthly logbook review, quarterly meta data spot check review, tracking/confirming completion of training for operators, and creating training curriculum/items as needed Show less

  • Senior Specialist, Manufacturing Compliance

    Jun 2020 - Jul 2021

  • Process Scientist II, Clinical Supply

    Jan 2018 - Jun 2020
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  AbbVie

  Jul 2021 - Mar 2024

  Pharmaceutical Operations Specialist/Project Manager II

  • Lead CAPEX/continuous improvement projects and own change controls, such as: o Optimizing material warehouse: Re-organized material storage areas improving material flow and management of inventory levels to reduce spending and reduce stock of excess material. o New equipment commissioning/qualification/validation: temperature baths, SCADA DAC units, and floor centrifuges. • Project management activities included: o Change control ownership o Collaborating with cross-functional teams and external contractors o Managing documentation (revision, review, and/or approval o Reporting out project status, key milestones, and risks/roadblocks o Utilizing MS Project or site-specific visual dashboards/trackers to generate project timeline and track action items and deliverables.• Support audits (including FDA, CDC, corporate, and internal audits) as runner, scribe, or SME. Additionally, implemented CAPAs from audit findings. o Awarded by Assoc. Director of Facilities for completing CAPA for an audit observation (involved revision to multi-site procedures).• Facilitated meetings for process FMEAs (materials and operations) and risk assessments (equipment, data integrity, and safety).• Manufactured commercial Botox drug substance and clinical drug substances in a GMP facility regulated by CDC, FDA, and global regulators.• Support manufacturing of new products, which required occasional domestic travel. Additionally, supported PAI readiness and regulatory filing activities.• Participated in Quality Systems meetings, Material Review Board meetings, and Tier 1/Tier 2 meetings.• Experienced with Maximo CMMS for Service Requests, Work Orders, Cal/PM job plans, and tracking asset inventory• Managed Manufacturing consumable inventory through routine cycle counting to ensure proper stock levels and ordered materials via Purchase Orders created in SAP ERP. Show less

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  Gilead Sciences

  Jun 2024 - now

  Quality Systems Specialist III

  Investigation Core Team (ICT)