Quality Assurance Control

Mimi Su

Irvine, CA

******@*****.*** - 949-***-****

WORK EXPERIENCE

LabWare LIMS Consulate

ALLERGAN PHARMACEUTICAL - Irvine, CA - March 2013 to Present

Responsible writing validation test script for functionality, configuration and deployment of LIMS at Research

Development Informatics Services.

Collaborated with IS Departments to facilitate validation activation; executed IQ/OP/PQ Test scripts.

Support the LabWare LIMS development team on write validation test scripts for validation and change

control.

Execute the validation test script for Empower 2 and LIMS interface.

LabWare LIMS Analyst Consultant

ALLERGAN PHARMACEUTICAL - Irvine, CA - September 2011 to December 2012

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 LaWware LIMS develop and/or execute test scripts as needed.

Executed test scripts for the validation process.

Executed User Acceptance Testing scripts

Assisted Department Supervisor in various tasks as needed.

Quality Control Associate

DENDREON CORPORATION - Seal Beach, CA - May 2011 to August 2011

Assists in management of test samples, reagents and materials used in the laboratory per approved

procedures (Complete Blood Count, ELISA, VIiability, Gram Stain and Kinetic LAL), and inspection of

Apheresis.

Quality Assurance LIMS Specialist (Temp.)

ALLERGAN PHARMACEUTICAL - Irvine, CA - September 2008 to January 2011

Trained Quality Assurance (QA) personnel to configure Labware LIMS.

Responsible for transcribing drug products and raw material specifications from paper based Documentum

system to Labware LIMS system.

Responsible for coordinating and processing Labware LIMS specification through the Change Control

System.

Ensured all analysis associated with specifications are complete, accurate and configured per established

procedures

Worked with Development team to implement and test accuracy and completeness of data migration

Assists Department Supervisor in various tasks as needed

Quality Assurance Specialist

ISTA PHARMACEUTICALS INC - Irvine, CA - August 2002 to September 2007

Reviewed, executed manufacturing batch records for compliance of manufacturing processes/steps,

ensuring that all applicable documents, records and forms are completed and attached.

Performed external audits of API vendors, contract laboratories, contract manufacturers, component

vendors.

Reviewed and approved QC laboratory data, including release, stability testing, validation, and technology

transfer data for accuracy. Reviewed manufacturing procedure, Standard Operation Procedures, and

analytical methods.

Promoted twice within four years for consistently outstanding work performance.

Quality Control Analyst III

HPLC, IC, SDS-PAGE, Protein Concentration Determination - 2002 to 2006

Developed proficiency in MS Office and excellent record-keeping skills in a cGMP release and stability

quality control laboratory.

Entered and reviewed assay calculation for the QA audit; conducted OOS investigations.

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..

Assisted in maintaining the inventory of laboratory reagents and supplies. Prepared for FDA inspection.

Chemist

HPLC, IC, SDS-PAGE, Protein Concentration Determination - Irvine, CA - January 2002 to May 2002

Performed United States Pharmacopeia (USP) dissolution, hardness, loss on drying, Karl Fisher, and

disintegration testing.

Calibrated and maintained the HPLC Physic-Spectra P1050 and UV Scan PC2100.

Quality Assurance Analyst

A PLUS INTERNATIONAL INC - Chino, CA - April 2001 to January 2002

Provided and planned validation study (IQ, OQ, PQ) for the Form-Fill-Seal machine Tiromat VA 560 / 430

and Paper to Paper package machine P120; evaluated data and wrote reports.

Provided document review, with strong attention to detail and good organizational skills.

Supplied a training program for company employees.

Research Associate

ELAN PHARMACEUTICALS - San Diego, CA - April 2000 to March 2001

Performed development testing of several Spiros® Dry Powder formulations, including Emitted Dose,

Andersen Cascade Impactor, Content Uniformity, Potency, Purity, Loss on Drying, Karl Fisher moisture testing,

Morphology, and Foreign Particulate.

Determined insulin concentrations and provided QC analysis using the HPLC 1100 / 1050 Series and Chem

Station Software.

EDUCATION

Bachelor of Science in Biochemistry

UNIVERSITY OF CALIFORNIA - San Diego, CA

2000

SKILLS

LabWare System Administration,

ADDITIONAL INFORMATION

Six years of LabWare LIMS experience in implementations, configuration, writing validation test script and end-

user testing. Solid analytical chemistry experience in cGMP compliance and documentation. Efficient, accurate

problem-solver with a positive attitude, good work ethic skills.

Contact this candidate