Yeman Wong

ad29ks@r.postjobfree.com **** Via Fresco, Camarillo, CA 93012 707-***-****

Summary

Highly accomplished Business Analyst, with a Master of Business Administration (MBA), successful track record of managing complex projects within budget and timeline; Developed business requirements and performs gap analysis between goals and procedures; Implement system improvements to increase productivity and reduce cost; Extensive experience in process improvement implementation to various departments and sites; Strong interpersonal skills, highly adept at diplomatically facilitating negotiations with clients, vendors and stakeholders; Additional areas of expertise include:

knowledge of the following

● Change Control Management ● Process analysis and redesign ● Management of cross functional teams

● Budget, planning, resource estimate ● Training ● Knowledge of Word, Excel, LIMS

● Document management ●Product testing, data analysis ●Regulations and inspection/audit readiness

Interacts with QC, Manufacturing and interacts with customers outside the Company

Professional Experience

GABE Inc at Amgen, Thousand Oaks, CA March 2023- June 2023

QA Specialist

Created drug substance manufacturing process and procedure within GMP guide lines

validate lab instruments

Write up validation of instruments

Reviews validation from other specialists

Work with lab analyst to complete the validation and to write up the protocol

Ensure documents is within GMP

KITE(contractor), Santa Monica, CA November 2022 – January2023

Quality System Administrator (Conduct QA review before handing off to QA)

Administrator of Benchling LIMS(Laboratory Information Management System) for Research

Work with the research/PD labs in Santa Monica

Assisted Lab in learning Benchling and getting the label printer set up

Coherus(contractor), Camarillo, CA August 2022 – September 2022

Qualiry System Administrator

Help in Lab to get instruments ready for Thermo LIMS

Administrator of Thermo LIMS

Administrator of Chameleon

Abzena, San Diego, CA November 2021 – August 2022

System Administrator looking at Quality with systems in the lab

LIMS (Biovia/Onelab) administrator for 3 Facilities in San Diego,

Works closely with Quality Assurance, Quality Control, Product Science and IT

Work closely with other System Administrators from other sites (Bristol, PA, Sanford, NC and Cambridge UK)

Attending meetings with Biovia to help and assist in setting up LIMS

Attending meetings to assist/learn stability and Environmental Monitoring modules.

Team to develop SOP for general LIMS use, EM, stability and change control in LIMS

Assisting in laboratories Computer set up with laboratory instruments

Federal Government, Port Hueneme, CA March 2021 – October 2021

Contract Specialist

Initiate contracts for military departments. Goal is to get the best price for the government.

oIn virtual classes to learn the following

Regulations and legal wording for initiating/completing a contract with vendors.

Money/banking side of a contract, how to word the contract so it favors the government and to ensure it does not favor the vendor. Insure there is funding from correct area for the contract

oLearning how to negotiate with vendors to complete a contract

oFollowed a co-worker while they go through the process on a contract.

oWill be involved in closing out a contract when completed

oWill have to work with legal, finance and department which requested the contract through the entire process

ATARA Biotherapeutics, Incorporated, Thousand Oaks, CA February 2019 – October 2020

SENIOR BUSINESS ANALYST (Quality Specialist ensure all paperwork was reviewed before handing it over to Quality)

Compiled requirements for Quality Control, Research and Process Development labs.

oDeveloped strategies to meet requirements

oWith the labs created User Requirement Specifications (URS)

oMatch URS with Functional Requirement Specifications(FRS) for Validation

Liaison with vendors and lab clients to troubleshoot issues with laboratory instruments

oCoordinated with Facilities when vendors are on site

Implemented Bartender application for Quality Assurance to print product labels for Clinical products. Bartender was only label software and did not interface with LIMS.

Worked closely with lab personnel and assisted with laboratory instrument applications

Provided user access for instruments in the labs once proper paperwork was filled out and signed off.

Worked with validation to validate instrument for GMP use

oAssisted validation to creating protocols for testing

Set up meetings with Research department to search for electronic laboratory notebook (ELN) for research lab

Was supporting Labware for LIMS as an admin

KITE Pharmaceuticals, Santa Monica, CA January 2017 – February 2019

SENIOR LIMS MANAGER – review all paperwork was reviewed before handing it over to Quality

Worked closely with manufacturing, Quality Assurance, Quality Control, Product Science and IT at multiple sites (Santa Monica and El Segundo)

oAssisted in gathering requirements for all departments and sites

Translating information to different departments and explaining to them what vendor is looking for

Liaison between LabVantage and KITE departments

oLearned the process for both clinical and commercial and non GMP areas

oTested LIMS and worked with Vendor to configure LIMS per KITE needs

oWork with IT to see how we can interface with other IT systems and instruments

Implemented LabVantage version 8.2 and have over 5 years of LabVantage experience working with different groups and sites

Configured Raw Materials in LabVantage

oWorked with Raw Material group and had them test the configuration.

oOnce they approved the configuration, it was moved to Production environment.

Worked with vendor to set up LIMS and resolve issues

Assisted vendor in training to all users.

oAttended all training given by LabVantage on site and if needed explain to users what the specific department had to do with KITE terms.

oAnswered questions from KITE users once LabVantage left.

Tested the interface between LIMS and Nucleo-Counter instrument.

Set up help desk for LIMS for user to report any LIMS issues

Set up change control for LIMS

Implemented Freezer works to track samples in various Freezers

oOver saw contractors to put in data in Freezer works

Notable accomplishments include:

Implemented Freezerworks to track samples in 3 months

oWas accomplished while KITE was looking for a LIMS

Involved in implementing ELN to product science

BAXTER/BAXALTA/SHIRE, Thousand Oaks, CA August 2014 –January 2017

BUSINESS ANALYST Ensure all paperwork was reviewed per quality standard

Support Laboratory Information Management System (LIMS) for Thousand Oaks and Hayward, CA

Worked with multiple departments in different sites to make LIMS use consistent within the company.

Perform Microbiology/Analytical Quality Control (AQC)/Manufacturing LIMS coding changes to match site and division procedures

Made suggestions and slowly implemented improvements to LIMS. Worked with users that have used the same version of LIMS that is 20+ years old.

oChallenge is to work with Clients that is use to the old way and don’t want change

Worked on cross instance between sites that uses different instances of LIMS, different instance for each site

Worked with division to get raw materials into LIMS

Support sites when there is an regulatory inspections

Train super users in laboratory and answer questions for them

Notable accomplishments include:

Slowing implemented changes to make LIMS easier to use for both clients and for the support team

Decreased time to make LIMS template configuration changes

Improved laboratory trending using data in LIMS from 1 week to 1.5 days

AMGEN INCORPORATED, Thousand Oaks, CA November 2001-August 2014

BUSINESS ANALYST, ensured the paperwork was reviewed per quality standards

Corporate level Business Analyst responsible for multiple systems, departments and sites

Lead for maintaining 24/7 application support

Communicate with clients/users on system down time for maintenance, software/hardware issues and enhancements

oTest system maintenance to ensure system is functional and send notifications when system is back up or is delayed and estimated duration

Work with clients to gather and translate requirements and work with Information System (IS)/vendor to assess feasibility and estimated duration of work to be completed

oCoordinate with clients to test enhancements in the test environment with appropriate documentation. Move enhancements to production upon approval from client

oMoved upgrade to production with proper paperwork in place

Perform and publish metrics to management on adherence to Service Level Agreements (SLA),

Successfully trained and transferred support to appropriate site group for steady state support

Created system Standard Operating Procedures and Qualification Documents

Manage contractors to ensure projects meet milestones and budget.

Research new systems for clients and coordinate vendor demonstrations

Work closely with labs to set up instruments to Laboratory Management Equipment System.

oSystem got rid of using paper/notebooks

Retired systems as they were replaced or not needed by clients

Transitioned LIMS support from Thousand Oaks to India.

Notable accomplishments include:

Team Lead in the implementation of LIMS (Laboratory Information Management System) to various company sites; Involved in client collaboration to streamline process and LIMS to increase efficiency by 40% in various departments

Used one instance of LIMS (Thermo) for 4 sites. Thousand Oaks, Colorado, Puerto Rico, Rhode Island. Site separate by Data Groups. Each site can only see their own data. Some user had access to all data groups.

On team that successfully moved from Perkin Elmer LIMS to Thermos LIMS.

Streamlined support by effectively negotiating SLA with clients to improve the process flow of LIMS-related work orders which in turn reduced open work orders from 120 to 16 within one month

Created queries and reports of LIMS template changes for client review and speedy closure of work orders; Increased frequency of queries by 30%

Project Manager for the implementation of new templates for commercial products in Puerto Rico. Resolved issues with clients and implemented various efficiencies to complete project 65% below budget; Coordinated with key IS support staff to draft SLA with clients; SLAs were signed off 2 weeks before target due date

Completed implementation of Eproofing Software 1 month before due date

QUALITY ASSURANCE ASSOCIATE June 1996-December 1998, Temp to Permanent

Performed audits of manufacturing facilities to ensure compliance with cGMPs, Code of Federal Regulations, and regulatory commitments and assisted in the resolution of quality issues. LIMS Client Group Liaison between manufacturing and information system departments. Project Lead for the development of the LIMS Standard Operating Procedure and Good Business Practice to ensure global consistency in the use of LIMS throughout the company

BIOMARIN PHARMACEUTICALS, Novato, CA October 2000-October 2001

QUALITY ASSURANCE COMPLIANCE SPECIALIST

QA Compliance Specialist responsible for resolving quality issues with Quality labs, manufacturing, facilities, and validation; Primary Quality representative for contract manufacturing to ensure compliance with current Good Manufacturing Practices (cGMPs) and company standards; Conducted Good Manufacturing Procedure documentation training for new employees

Notable accomplishments include:

Team member in identifying requirements for the selection of LIMS and Document Management System (DMS) to the company

oProvided key feedback and databases in workarounds before DMS could be implemented

Project Manager in the development of a deviation process

oDefined department responsibilities in the Deviations Standard Operating Procedure (SOP)

oProvided biweekly status reports to Senior Management

oConducted weekly follow-up meetings with supervisors and managers

oCreated and maintained the Deviations database

oProject lead to the closure of old deviations and after implementation, 90% of deviations were closed within 30 days

Project Manager for the creation and development of an internal audit SOP and program

oSuccessfully prepared company for FDA inspection

NADERI ENGINEERING, INC. at BAYER PHARMACEUTICALS, Berkeley, CA August 1999-October 2000

SYSTEMS ANALYST

Systems Analyst, served as a liaison between end-users and programmers; Interacted with the Quality department to attain requirements for the implementation of LIMS. Coordinated schedule for all validation and programming work; facilitated weekly meetings with key stakeholder on project updates and progress. Authored, performed, and reviewed validation protocols (Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ)); provided technical support and troubleshooting during LIMS implementation and monitored LIMS change control program

Notable accomplishments include:

Team lead for the development and implementation of a LIMS SOP and training program; Successfully trained 100% of all end users

Team lead for software error investigations and software enhancements; Presented findings and corrective actions to project manager and stakeholders; Successfully lead and implemented two system enhancements

BIO-RAD LABORATORIES, Richmond, CA January 1999-July 1999

QUALITY ASSURANCE/REGULATORY AFFAIRS SPECIALIST

Site contact for vendor audits and project coordinator for identifying corrective actions for audit responses; Compiled and analyzed department budgets and presented recommendations in cost savings to management; Initiated, reviewed, and approved SOPs and Manufacturing Procedures; Conducted batch record review and disposition of final product; Developed a guidance document on how to compile and analyze budget reports for management; Project lead in creating a Housekeeping and Hazardous Waste Storage SOP; QA/RA Database Administrator, created and maintained databases for Batch Record review and audit tracking

Notable accomplishments include:

Managed project that cut hazardous waste cost by 300K per year

Education & Credentials

Master of Business and Administration, Pepperdine University, August 2004

B.S. in Biotechnology with an emphasis in Business, California State Polytechnic University, Pomona, December 1996

Project Management Professional (PMP), September 2005 – Inactive

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