Mimi Su Email & Phone Number

Irvine, Ca, Us

Santa Monica, California, Us

Santa Monica, California, Us

•Quickly analyze specifications, method and sampling plans to convert to LIMS master data•Comprehension of master data details to translate from quality documents to LIMS system•Represent Clinical QC as the primary point of contact for LIMS establishment and development within Kite.•Establish processes and procedures for LIMS within the Clinical QC group in collaboration with corporate and commercial counterparts.•Coordinate with stakeholders for equipment validation and manage validation activities in alignment with established timelines•Responsibility for ensuring electronic data meets 21CFR Part 11 requirements in alignment with internal procedures•Assist with deviation, investigation, CAPA and change control activities as needed•Support inspection readiness activities •Participate in generating training module and instruction led training material

Foster City, Ca, Us

Helps maintain the health of the currently released LabWare LIMS system in the production environment, ensuring system performs its intended functions accurately and reliably.Provides end-to-end support for tickets requiring system change.Investigates user requests to determine if the problem lies in the LabWare system. For issues that become an approved LIMS change request,Provide troubleshoot/debug/error resolution with LIMSBasic and Crystal Reports.

Silver Spring, Md, Us

Provide daily support for STARLIMS migration, configuration, implemention to meet site requiremenAnalyze site user needs to determine functional requirementsFacilitate meetings, system configuration and development evaluations and site acceptance testing.Work with program and centralized team to evaluate site needs versus STARLIMS system capabilities and determine best approach within the system for configuration for enhancement requests or issue resolution.Work with program and centralized team to troubleshoot instrumentation issues and maintain instrument controllers.Configure the STARLIMS application in all aspects including Electronic Laboratory Notebook useProvides instrument specific knowledge regarding instruments, instrument controllers, and their integration with a LIMS. Performs installation, configuration and integration of instruments and instrument controllers.Provides coordination with equipment manufacturers to install, maintain, and troubleshoot instruments and instrument controllers. Also provides support for the operation of a LIMS.

Irvine, Ca, Us

Develop and executed IQ/OQ/PQ test scripts for LabWare ELNAdminister security changes to the LabWare LIMS, including creation of new user accounts, changing security levels as authorized, maintaining appropriate documentationGather user requirements and lead user acceptance testing activitiesPartner with the software quality department to support validation activities Provide first level diagnosis and troubleshooting of incidents to support business usersManage the LIMS change control process through timely resolution of incident tickets

City Of Industry, Ca, Us

Support implementation, configuration, and validation for LabWare LIMS projectCreate/update FRS, User Requirement, Instrument, Standard & Reagent, Analysis, Folder Manger, and ELN worksheet.Ensure all the implementation of LIMS requirement are define in the FRS.Wrote all the configuration documents, FRS, test scripts, and validation team in various tasks as needed.Support Labware developer on various tasks as needed.

Dublin, Coolock, Ie

Responsible for testing the functionality, configuration and deployment of LIMS at Pharmaceutical Analysis and Microbiology group in collaboration with Research Development Informatics Services.Collaborated with IS Departments to facilitate validation activation; executed IQ/OP/PQ Test scripts. Developed thorough test plans to validate accuracy and consistency of electronic data entered in, retrieved or routed through Labware LIMS develop and/or execute test scripts as needed.Support PAM Administrator to create/review/approve LIMS protocols for finish products, raw material and stability studiesResponsible for configuration drug products and raw material specifications from paper based system in Documentum to Labware system.Ensured all analysis associated with specifications are complete, accurate and configured per established proceduresResponsible for coordinating and processing Labware LIMS generated specification through the Change Control System Assisted Department Supervisor in various tasks as needed.

Dublin, Coolock, Ie

Responsible for testing the functionality, configuration and deployment of LIMS at Pharmaceutical Analysis and Microbiology group in collaboration with Research Development Informatics Services.Collaborated with IS Departments to facilitate validation activation; executed IQ/OP/PQ Test scripts. Developed thorough test plans to validate accuracy and consistency of electronic data entered in, retrieved or routed through Labware LIMS develop and/or execute test scripts as needed.Support PAM Administrator to create/review/approve LIMS protocols for finish products, raw material and stability studiesExecuted test scripts for the validation process with implementation of GMPExecuted User Acceptance Testing scriptsAssisted Department Supervisor in various tasks as needed.

Seal Beach , Ca, Us

Inspection of Apheresis, and Login the sample by using the Labware LIMSPerforms routine and non-routine analysis of environmental monitoring program, raw material, in-process and finished products during release or stability testingAssists in management of test samples, reagents and materials used in the laboratory per approved procedures such as Complete Blood Count (CBC), ELISA, Viability, Gram Stain and Kinetic LAL

Dublin, Coolock, Ie

Trained Quality Assurance (QA) personnel to configure Labware LIMSResponsible for transcribing drug products and raw material specifications from paper based system in Documentum to Labware system.Ensured all analysis associated with specifications are complete, accurate and configured per established proceduresResponsible for coordinating and processing Labware LIMS generated specification through the Change Control SystemWorked with Development team to implement and test accuracy and completeness of data migrationAssists Department Supervisor in various tasks as needed

Consistently provided the required level of guest service and ensured the attainment of required levels of quest satisfaction, while adhering to the reasonable constraints of sound management practices. Responsible for the operational profitability of the restaurant on an annual basis. Responsibilities included four categories: human resources, administration, sales and marketing, and restaurant maintenance. Supervision of a staff of 20 plus employees within restaurant, bar, and maintenance.Administered an effective program of recruitment, training, development and review. Established a training program to ensure the adequacy of all training materials, job descriptions, and department manuals.Established a professional and positive working environment with clearly defined expectations and a consistent program of employee recognition and accountability.Contributed to the definition of a realistic and attainable operating budget for the restaurant and worked diligently for the attainment of profit results.

Irvine, Ca, Us

Reviewed batch records, validation reports, protocols and amendments.Reviewed, executed manufacturing batch records for compliance of manufacturing processes/steps, ensuring that all applicable documents, records and forms are completed and attached.Conducted external/internal audits and analyzed QC laboratory data, including release, stability testing, validation, and technology transfer data for accuracy. Reviewed manufacturing procedure, Standard Operation Procedures, and analytical methods.Worked with regulation submissions and participates in FDA inspection.Promoted twice within four years for consistently outstanding work performance.

Irvine, Ca, Us

Established trusting relationships with customers and co-workers; developed customer service skills.Supervised five-member team and managed daily lab operation, including data trending, test scheduling, supply purchasing / sourcing, and customer relationships.Coordinated and performed variety of quality control (QC) assays (HPLC, IC, SDS-PAGE, Protein Concentration Determination, activity assay, and Karl Fischer) to support drug substance, drug product, in-process material, and stability testing in accordance with cGMP regulations.Monitored / verified QC operations to ensure compliance with written procedures and regulatory requirements.Ensured analyst training was properly documented and in compliance with QC procedures and cGMP.Demonstrated excellent troubleshooting skills with laboratory equipment and testing. Wrote validation reports, investigated Out-of-Specification (OOS) and generated reportsCommunicated effectively with other departments on assigned tasks.Addressed and managed deviations related to analytical procedure.Generated analytical test methods for raw material, bulk, release, stability, experimental, and validation studies.Assisted in maintaining the inventory of laboratory reagents and supplies. Prepared for FDA inspection.

Dublin 2, Ie