Sheila Chou Email & Phone Number

Alameda, California, Us

Alameda, California, Us

South San Francisco, California, Us

Provide Quality oversight to internal and external customers.Solve a wide range of difficult Quality issues impacting multiple functions following cGMP standards.Monitor QA activities to evaluate trends, report anomalies, observations and present findings to Quality Review Board and senior management.Support creation, maintenance and review of Risk Management documents.Facilitate engrained Quality in customer groups through collaboration, coaching, and co-creation.Positively impact goal achievement through informed decision making and continuous improvement.Develop strategies and provide technical assessments consistent with Genentech policies, goals and visions.

South San Francisco, California, Us

Liase with commercial, contract, and clinical teams to ensure strong QMS design of Patient Support Programs provide robust collection of quality safety data and medically relevant information.Assess risks, analyze data trends, and understand business priorities in order to influence Vendor strategies.Act as Pharmacovigilance Subject Matter Expert for Service Provider processes. Conduct robust Root Cause Analyses to inform effective CAPAs.Foster strong cross-functional and external relationships through conducting routine meetings, quarterly metrics reviews, and annual on-site Vendor visits.Product launch and Service Provider stand up with successful implementation.

South San Francisco, California, Us

Provide Quality oversight to multiple support groups, including QC laboratories, Raw Materials, Environmental Monitoring and Lot Release.Lead and participate in design and implementation of department and cross-functional initiatives for continuous improvement/team governance.Serve as Quality Oversight and consult for customer groups, across departments/sitesAssist in investigationsEnsure detection, appropriate classification, compliant assessment and robust resolution of deviations.Solve a wide range of difficult issues impacting multiple functions through adherence to cGMP regulations through application of scientific theory, technical principals and expert judgementImplement collaborative, scalable, long-lasting solutions through CAPA/corrective actions

South San Francisco, California, Us

Timely scientific analyses of stability, bulk and release to market samplesPrimary discrepancy assessment for 20 analysts; excellent technical writing and problem solving skillsProficient at multiple systems including Trackwise, LIMS, SAP, MS Project, Visio and MS Office SuiteProject management across multiple sites; remote and global collaborationSkilled presenter for both internal and external audiencesNominated Finalist for OE Person of the Year 2009Innovated usage forecasting currently used across sitesDeveloped forecast which leads the network in performance, accuracySchedule test and review activities for 6 individual contributors 5S representative; responsible for 10 point increase in 5S score over 6 monthsToastmasters Vice President of Membership, Genorators Club, Vacaville

South San Francisco, California, Us

Performance of in-process assays supporting the manufacture of multiple release to market products At ease in a fast paced, dynamic environmentFamiliarity with specifications, COA, trend assessmentAuthored critical reagent qualification reports for internal and external groupsPioneered inventory tracking system which was later implemented across multiple groupsNegotiate and write service level agreements with internal customers governing departmental relations

Conducted in-process, stability, clinical and final container testing for various productsFamiliarity with coulometer, osmometer, wet chemistry techniquesAuthored re-evaluation and cross validation reports to maintain testing resourcesScheduled lab testing activities and lab maintenanceRevised test procedures to reflect best practicesCollaborated with various manufacturing, stability and clinical groups to coordinate testing activities

Responsible for the primary fermentation and recovery of marketed productsOperation of 1500L fermentor, clarification centrifuges, and various process vesselsSkilled in aseptic technique, use of LAF and biosafety hoodsActively participated in Manufacturing Safety Committee: Observation Team committed to preventing safety hazards in the workplacePromoted to Associate II

Bachelor Of Science, Biological Sciences; Molecular And Cellular Biology

Education record