Data Analytics
Resume:
MICHELE
VAN
CONTACT INFO
LAKE FOREST, CA 92630
C: 562-***-****
E: ***********@*****.***
About
Achieve business objectives by driving
organizational strategies, aligning messaging,
developing teams, and engaging stakeholders.
• Decisive in managing inquiries and
cementing vital professional
relationships with internal and external
partners.
• Highly organized leader with an in-depth
understanding of iron triangle attributes
and its effective management.
• Strong familiarity with risk-based
approaches (RBM) for Site/Clinical
Operations, Facility/Lab Management, and
Process Improvement.
• Proven demonstration of excellent
services in multiple disciplines.
Specialties with IQ/OQ/PQ, DOE/PV/VMP,
FAT/SAT/CQV/CSV, CCR/PR, CAPA/NC, Product
Complaints Handling/Post Market Surveillance,
Compliance, Risk Assessments, Internal
Audits/External MOH, and QMS/QC.
Skilled in Accounting Auditing, Financial Analysis, Tax Reporting, Quantitative/Data Analysis, and
Six Sigma/Control Charts and Variations trending.
Education
Continuing Education – Six Sigma Green Belt
University of Southern California
Jun 2024
• Awarded credentials (ID 107580291, Expiration
Date: 06/30/27) to practice lean six sigma body of knowledge in the industry.
• Received an A on the exam with IISE Administration. Master of Science – Finance
California State University of Long Beach
Jul 2021
• Graduated with cum laude distinction after passing a comprehensive exam.
• Accepted by AACSB Accredited Program for fast-
track curriculum (1-Year).
• Certified Python programmer.
• Certified Bloomberg for Education (BME) analyst
Bachelor of Science – Biomedical Engineering
University of California – Irvine
Jul 2011
• Minor in Materials Science and specialization in Biophotonics.
• Awarded Undergraduate Research Opportunity
Program (UROP) grant for research.
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Skill
Analytics: power bi, rstudio, tableau, power
automate, python, power app, bloomberg, business
databases, & smartsheet
Statistics: regression, spcs, minitab, & t-tests
QMS: trackwise, crystal access / sql, lims, etq, & veeva Controls: deltav, bmram/cmms, bas, rees, &
cytiva(unicorn)
Microsoft suite: word, excel, ppt, visio, project, list, pivottable, vlookup, & vba
Investigative: dmaiic, pareto, root causes, ishikawa, 5whys, fmea rpn, & muda
Validation: ellab valsuite, kaye validator, & metrology calibration
Other: comsol, solidworks, sap erp, & jd edwards
Experience
DIRECTOR – BUSINESS OPERATIONS • AUG 2023 TO FEB 2025 JLL • Lake Forest, California
Designed and implemented a new KPI program based on a statistical framework in Excel to track performance goals.
• Communicated progress/challenges of deliverables to aid stakeholders in decision-making and planning.
• Implemented a new Change Control Management program and Visio process flow map to guide data management activities.
• Developed and approved Functional Test Plans (FTPs) to test KPI module configuration changes.
• Monitored KPI scorecard for Lease Admin, Project Management, Workplace, Transactions, and Portfolio Strategy.
• Supported Interim Account Director with Account Management activities with clients.
• Prepared annual reporting and administrative review of year's end covenants. Created visually compelling dashboards/analytics in Power Bl (cost effective alternative) for:
• Onboarding process - which reports headcount, hierarchical reporting structure, and logistic information.
• Financial data, which reports data insights based on metrics (EBIT, EBITDA, and P/B).
• Innovative proposal tracker, statistical distribution of data, and key influencer charts.
• Experienced in managing projects, ensuring timely delivery and adherence to budget/cost. Conducted QBRs, Account Business Planning, and Strategic Meetings for RTX-JLL Partnership and attended meetings and conferences to build collaboration and team camaraderie with our customers.
• Employed innovative strategies and concepts to overcome unique client challenges. 3
• Maintained VOC process with Clients, emphasizing strong focus on keeping current level of satisfaction through tuning/feedback loops over semi-annual sampling cycles.
• Increased Response Rate from 30% to 50% and achieved highest ever NPS.
• Conducted a 3-period review and graphed data along with insights.
• Managed documents and trace matrix with Paralegal and Sr. Counsel. Worked on legal review and contract score assessment for CRB renewals.
• Procured successfully new RFP/RFS for Klang, Malaysia property. Helped with attainment of other POs/RFPs. Also, drafted legal stipulations for Client and showed areas/sources of conflicts and remedies.
• Provided legal documents expertise and managed contracts/case inquiries from COEs/Clients.
• Oversaw group design project of Org Chart in Power Bl, starting from proof of concept to prototypes and MVP.
Monitored and managed productivity of staff and team to achieve targeted goals and other financial, compliance, and operational goals (mostly mandates from Momentum and GAME).
• Developed compliance protocols to keep in line with established standards.
• Conducted audits to evaluate internal controls with respect to Cost Savings, GAAP measures, and Contribution Income.
• Collaborated with account operations teams to understand key processes (client drivers, account strategies, growth plans, and risk mitigation). Also, re-trained or remedied gaps in knowledge and skills.
• Completed backlog items in Mv4 and propelled a team of ADs and support members to new baseline/normal, from avg errors of 5.0 per account (15 total) to 2.0 per account over 3 months. Minimally met threshold rate of 90% rate of data completeness after 1 month.
• Was accountable for global performances (AMER, LATAM, EMEA, and APAC) in Mv5 and consistently achieved 95%.
• Produced informative newsletters to report organizational team on compliance-related activities, system changes, and legislative initiatives. Leveraged business knowledge and leadership skills to motivate/lead improvements across internal and external groups.
• Motivated and coached mentee in support of Workday Empowering You (Leadership Development Program).
• Completed Account Director curriculum as part of LERN (Latino Empowerment Resource Network).
• Managed direct report(s) in support of the National Intern Program to develop future Data Analysts. Also created training materials/artifacts for Data Analysis Internship Curriculum. MANAGER OF OPERATIONS • JUN 2022 to JAN 2023
IPS • Irvine, California
Directed project work to support QMS remediation while collaborating with cross-functional teams.
• Determined interdependencies and project critical paths during strategies and scopes planning with Directors from MSAT, QC Lab, and IT Eng.
• Evaluated 3 years of data for clinical lots from Veeva based on risk profile and event characteristics.
• Built a dashboard in Excel to aid with tracking, monitoring, and measuring performances.
• Delegated tasks, duties, and responsibilities to each team member and kept close connection and communication with project personnel to quickly name problems/obstacles. Successfully reduced # backlogs (256 total) by 50% at the end of 3 months. 4
• Scheduled War Room meetings to provide guidance/solutions to support Owners/Investigations.
• Generated lessons learned map for Calibration OOTs, which provided strategies to reduce lead time or cycle time for better process efficiencies.
• Summarized metrics through weekly reports and presented project status/results to Stakeholders.
• Developed an alternative method for manual measurement of RAD lrradiators due to limitations with instruments. Alternative method presented and accepted by Upper Leadership and CEO for implementation.
• Mapped 3D radiation profile of lrradiator's performance. Created an algorithm via programming/coding that automated the monitoring of clinical and commercial lots due to constraints with Veeva to support MSAT with daily operations.
• Implemented VBA as a solution to support Operations with trending for critical/impacted lots.
• Used VLOOKUP to combine different sheets and consolidate data into a Master Aging QE Tracker for monitoring/trending. Led validation efforts for new Myford South GMP Facility.
• Reviewed tech documents such as URS/FDS, IQ/OQ/PQ/CSV, Vendor protocols, and SOPs.
• Ensured staff's adherence to consistent applications of GxP for compliance and regulatory reporting requirements.
• Prepared agendas for external workgroups and internal project teams, organizing meeting materials for distribution.
• Trained employees and subcontractors on validation processes and lab protocols. Equipment involved: Akta Gradients, pH, and Conductivity Meters, Biowelders, AHUs, HEPAs, Palletanks, Chillers/Cooling System, Facility Validation, and Environmental Monitoring PQ. PRINCIPAL QUALITY ENGINEER • JUN 2021 TO APR 2022
BAXTER • Irvine, California
Managed a team of QEs, MEs, and QAs to meet commitments for Audits, NCRs, and Validation Gaps.
• Determined interdependencies and project critical paths during strategies and scopes planning with MSAT Director.
• Provided expertise in the areas of Quality Assurance, Regulatory Compliance, Production Controls, Nonconformance Management, Risk Management, Statistical Techniques, and Sampling Plans.
• Reviewed and optimized validation protocols, addendums, and SOPs.
• Tracked and reported on Quality Inspections and GEMBA Walkthroughs.
• Developed risk assessments for airflow tester settings to improve scrap rates and researched feasibility, design or performance of components or systems.
• Resolved validation gaps associated with equipment. Conducted verification/calibration for scientific/technical equipment if considered needed as a remedy.
• Analyzed complex data sets and applied strong problem-solving skills to resolve issues. Restructured facility validation program and incorporated novel changes.
• Obsoleted revalidation maintenance/metrology process and replaced with continued process verification (CPV). Original process had redundancies and did not truly trend process or operating parameters after validation.
• Became a Quality Champion based on NCR investigations (e.g., Power Outage, Failed Pull Test - MQC Check, and Failed AQL Inspection for Packaging Orientation).
• Conducted OOT investigations, reviewed various MQC procedure results within POMS (MES) to allow continuous operations, and checked QM release criteria such as MOCs or raw material integrity results.
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• Audited HEPAs, AHUs, Generators, and UV/RO. Provided continuous process improvement and CA/PA to facilitate operational efficiency.
Participated in Internal Audits and supported MOH Global Region Audits (External), completed regulatory assessments (e.g., electronic complaints or clinical outcomes) concerning patient safety and hazardous situations, and presented Tier 3 Management slides and quarterly meeting reviews.
• Successfully reduced monthly CIPM by 5% for the year 2022. Reduced costs from post- market surveillance of complaints/defective products and through continuous improvements of our products.
• Daily reporting of CIPMs, projected forecasts/estimates, and supported client/customer interactions with regions globally.
• Implemented a new forecast method for CIPM based on the finance concept of moving averages, which provided early predictors.
• Interpreted and translated regulatory requirements (e.g., ICH, ISO, and USP) into actionable processes.
• Compiled data on complaint issues and vulnerabilities and reported findings with suggestions for improvement. Communicated with coworkers and QE Senior Manager about analysis results.
• Rebuilt data structure for easier tracking/trending/recategorization of CIPM based on geographies and failure codes.
• Designed engineering experiments to evaluate failure codes (backflow at fillport and glass PMs) to optimize products. Also, addressed/reviewed evaluations of risk triggers due to alerts for hazardous situations and assessed trends using post-marketing listening systems.
• Resolved aging evaluation records through risk assessments.
• Drove change to trigger formula to allow for recalculations as a system improvement. SR. OPS ENGINEER • JAN 2020 TO MAR 2021
ImmunityBio • El Segundo, California
Collaborated with cross-functional departments (Quality, Manufacturing, and Engineering Managers) to define change controls requirements for the GMP Pilot Plant Startup project and drive schedules to meet deadlines.
• Interacted with Vendors and defined project scopes and project orders.
• Streamlined and managed processes for documenting, filling, and communicating decisions.
• Planned, assigned, and tracked the WBS components/Change Control activities.
• Conducted retrospective sessions to gather feedback from the project team's review of tasks/process improvements for the next iteration (2 weeks).
• Worked on bid documents for facility work such as Sensor Calibration or HEPA Filters Certification.
• Used a hybrid project management approach. Negotiated with TSS and Camfil for better quotes/pricing rates.
• Developed a new Asset Maintenance Management program and created a new schema for equipment criticality classification and various engineering processes. Oversaw FAT of Vanrx Filler, 83 Duley HVAC, and Eng PQ for Rooms TPs/DPs as a Buyer's representative.
• Specified system components or direct product modifications to verify conformance with engineering design or performance.
• Executed quality reviews of relevant documentation such as FAT and commissioning/validation to ensure accuracy and completeness. 6
• Verified exit-cal and decommissioning documents for outdated instruments for new upgrades.
Served as the Cross Functional Team Lead/Project Manager for lmmunityBio participation in Op. Warp Speed for Covid Vaccine.
• Recommended strategies for improving bottom line with better personnel, resource, and schedule management.
• Worked with management and front-line employees to develop production and design standards.
• Outlined best methods for fabricating and assembling individual parts and final products. VALIDATION ENGINEER IV • MAY 2018 TO DEC 2019
PSC Biotech • Pomona, California
Maintained consistent, high-quality validation process to bring Douglas Facility to GMP state, license received in June 2019 by California DPH (0 observations).
• Formulated procedures and criteria. Closed Validation documents to confirm installation and functional aspects of equipment/systems/processes.
• Designed a new temperature mapping plan for equipment and mapped CBS LN2 chambers.
• Investigated equipment failures, identified causes, and initiated methods to resolve such issues such as inspection, calibration, and instrument testing.
• Presented complex technical data in easily understood terms to individuals without engineering backgrounds.
• Developed an alternative method for manual measurement of RAD lrradiators due to limitations with instruments. Alternative method presented and accepted by Upper Leadership and CEO for implementation. Mapped 3D radiation profile of lrradiator's performance.
• Created a statistical plan to prove accuracy/ reproducibility and sampling size to qualify equipment's performance.
• Invented a new data interpretive method to limit abnormal results due to Instrument/Operator's errors.
Equipment qualified: NuAire LHF, Climet Particle Counters, EMTEK Microbial Air Samplers, CBS LN2 Freezers, lrradiators, Douglas AHU/HVAC, Container Bag Printing, and Schubert Packaging. CONSULTANT • SEP 2011 to MAY 2018
BIOSPEQ/AZZUR • Irvine, California
Drove validation efforts and provided continuous feedback to various departments. Supported Sr. Project Manager/PMO in planning, defining project deliverables, and scoping out project activities.
• Initiated Change Control records for shutdown/startup and actively drove progress on tasks to ensure completion within due dates and budget constraints.
• Reviewed RTM criteria against work completed during closure and generated Annual Reports for submission to Regulatory Agencies.
• Released equipment for use with Norepinephrine products in 2018 for Teva, which was a major item as products were on hold since 2007.
• Created a checklist manifesto to condense 50 pages SOP into 1 page for ease with execution.
• Successfully created in-house particulates spiking procedure for Norepinephrine due to constraints vendor did not accept oncolytic products.
• Increased sales quotas as a Project Lead by finding new Validation projects in Van Nuys for Temperature Mapping.
• Mentored associate consultants to encourage enthusiasm toward tasks and execution. 7
• Conducted technical training on the uses of equipment, protocols, and procedures for temperature mapping/validation of -20C Freezer, +5 Cold Room, and Ambient Room in Warehouse.
• Programmed temp/RH sensors and executed calibration procedures for pre-run and post-run verifications. Addressed out of tolerance (OOT) incidents with Metrology.
• Cultivated trust with clients and built support with Van Nuys' decision makers throughout the entire project lifecycle to ease execution, procure materials and inventories, and maintain Stakeholders' engagement.
• Reviewed completion of activities against a Definition of Done (DoD) checklist to ensure the acceptance of criteria via Stakeholders' satisfaction. Tracked project hours and time/material costs for the team (3 engineers and 2 operators/technicians) and reviewed timesheets and checked overall budget and expenses.
• Implemented a predictive project management approach.
• Produced positive results and contributed to the success of clients such as Baxter LA, Van Nuys, and Teva.
• Leveraged industry expertise to create robust long-term business strategies to support projects and validation activities.
• Decommissioned old Buminate capper and commissioned/validated new ISO 5 capping system. Completed RPN assessment for new capper design.
• Ran experiments from DOE protocols with Lead Engineer to evaluate capping head pressure loads, jog controls, and photoelectric sensors.
• Evaluated user requirements and risks to determine scope, potential problems, and actionable solutions.
• Performed analytical method validations, reviewed LIRs/MIRs, and supported EM, including VHP protocols, and mfg. rooms and zones. Managed data trending from Crystal Reports (SQL) and LIMS.
Equipment validated: Eisai Visual Inspection System, NuAire BSCs, HIAC Liquid Particle Counters, Libra Vial Washer, Cozzoli Capper, Domino Packing Printers, +5C Cold Box, - 20C Freezer Warehouse, and Ambient Warehouse. Served as a Consultant Project Manager supporting the Refrigeration Systems A and B Validation for Baxter Van Nuys.
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