ANH THAI

*** ******** **** **** *********, CA ***28 760-***-**** acuzb4@r.postjobfree.com

OBJECTIVE

Looking for a respectable organization which will utilize my background in:

Quality Assurance

Writing and revising SOP, Work Instruction followed FDA and internal auditing

Initializing CAPA, Non Conformance Report, and Engineer Change Order

Documenting of DHR

Maintaining quality records to ensure compliance

Quality Control

Antibodies in immunology lab

Reagents and chemicals in formulation lab

Validation of instrument and reagents

Inventory and batch records with SAP and Axapta systems

SKILLS

Lean Manufacturing, Compliance with cGDP, cGMP and Standard Operation Procedure

Internal and FDA auditing

ELISA, PCR, tissue culture, specimen collection of: cells, tissue, peripheral, and bone marrow, complete cell count, blood count; lymphocyte, stem cell segregating with Flow Cytometry

Training new team members

EXPERIENCE

QA Associate III

SenDx Medical Inc., Carlsbad, CA 2011 - 2015

Prepare and maintain QA work instructions, Finished Device Inspections, and Standard Operation Procedures

Continuously update standard operating procedures for compliance, accuracy, and simplicity

Utilize Axapta and Master Control for daily recording and updating documentations

Establish quality standards; implement QC system to enhance quality of products

Initiate and follow up ECO, and maintain DHR

Identify deviations areas of non-conformance, initiate an NCR or CAPA and undertake relevant modification

Ensure GMP and regulatory compliance during the manufacturing, testing, packaging, and distribution by conducting audits, documentation reviews and continuous follow ups

Quality control testing and verifying of Blood Gas Analysis devices and its consumable materials

Training new team members

Sr. Quality Control 2009 - 2011

Syntron Bioresearch Inc., Carlsbad, CA

Implemented quality improvement programs including spot audits, root-cause analysis, and implementation of remedial actions

Produced short-term and long-term production scheduling, forecasting, monthly analysis, and cost forecasting

Performed quality control inspection on Incoming Raw Materials and communicated with vendors regarding quality and delivery issues

Executed functional inspection and testing of retained samples to support customer services

Performed validation testing of medical devices for allergy, cancer, drugs of abuse, fertility, infectious diseases, and thyroid detection

Issued Certificates of Assurance and Certificates of Compliance for validated medical devices

Research Associate I, Stem Cell Lab 2007 - 2009

Brain Therapeutics Medical Clinic, San Clemente, CA

Performed in vitro stem cell culturing with supplements

Performed CD34 count for stem cells stimulation on peripheral blood and bone marrow using Flow Cytometry Instruments

Performed RT-PCR for DNA, RNA purification

Installed and troubleshot laboratory software application

EDUCATION

Bachelor of Science, Biochemistry

University of California, San Diego, La Jolla, CA

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