Quality Assurance Specialist

Jaymie Hu

** ****** ****** **. ******, CA, ****6, 909-***-**** ********@*******.***

EDUCATION:

University of California at Los Angeles

Major: Bachelor of Science in Biology 2007

Career Objective

To obtain an-entry level position in Regulatory Affair

Significant qualifications includes

Possess knowledge in field in clinical and lab data

Strong analytical, evaluation and interpretation skills

Excellent planning and decision making abilities

Ability to exercise control the executed tasks with the planned activities

Perform analysis of the given data and draw accurate inferences, in accord with the objectives of the analysis

Activity 2011-2011

Regulatory affair certification (from Regulatory Affairs Professionals Society) emphasis pharmaceutical completed in 2011, classes completed as the following:

Ethics, Regulation of US and EU Biologics, Pharmaceuticals: Compliance and Audit, Ethics Simulation, Pharmaceuticals: Global Regulatory Strategy Simulation, Good Manufacturing Practices, Role of the Regulatory Professional, Pharmaceuticals: Definition and Lifecycle, and Global Regulatory Strategy: Pharmaceuticals.

EMPLOYMENT:

Senior Quality Assurance/Regulatory Compliance Specialist January 2009- Present

Investigation and problem solving to ensure compliance with cGMP, SOPs, ISO 9001, regulatory compliance in dietary supplement and herbal extraction.

Phytochem International, Inc

Quality Assurance Department

Ontario CA

Establish and maintain regular status reporting on CAPAs and complaints.

Identify trends and indicators resulting from complaint process.

Facilitate root cause analyses activities associated with CAPAs and complaints.

Facilitate development of CAPA action plans and their implementation

Write investigation reports, CAPA content and complaint responses.

Responsible for preparation, release and approval of specification for COA

Final review vendor questionnaires to meet cGMP compliance

Manage products failure issue

Product label approval

Preparation of SOP’s and general Working Instructions

Preparation of vendor assessment program.

Familiar with FDA 21 CFR Part 210-211

Data Review (Protocols, Instrument calibration and usage Records, Daily and Monthly Backup Of Instrument)

Handling of Planned and Unplanned deviation.

Internal and Customer Audits to meet cGMP.

Clinical Research Analyst January 2007- November 2008

Monitor the clinical trial progress ensuring that it is recorded, conducted and reported in accordance with Standard Operating procedures (SOPs), protocol, Good Clinical Practice (GCP), and the relevant regulatory requirements. Provided study training and administer protocol to assigned site.

Amphastar Pharmaceutical Inc.

Clinical Research Department

Rancho Cucamonga, CA

Ensure the successful approval by FDA of newly developed pharmaceutical drugs

Plan and arrange site monitoring visits with clinical research coordinators to complete

clinical trial reports

Confirm accuracy and integrity of collected patient’s records

Analyze data records collected from clinical trial documentations

Draft, modify and customize informed consent forms for each clinical trial study

Complete quarterly reports and analyze study results to ensure compliance with

strict testing procedures

Prepare and review contracts and budgetary plans for each individual clinical trial study

Assist the medical director to grant a waiver for patients who cannot complete clinical trials

Detailed knowledge of GCP and ICH guidelines including basic understanding o regulatory requirements.

Comprehensive knowledge of S.O.P.'s for site monitoring.

Assist supervisor to review, finalize and submit medical documentation for FDA approval

Prepare clinical data, analyze, and consult with IT department to perform bio-statistic analysis

Prepare quarterly clinical report and submit to Clinical Department VP

OTHER SKILLS:

Professional in MS Excel, Word, Access, and Power Point, Visio, Oracle Database and, Database

Designed, Microsoft SQL Server 2008

Fluent in spoken and written Mandarin Chinese and English

Comptia A+, Network+, and Security+, Cisco Certified Network Associate, Cisco Certified

Understanding database needs and functions, creating data models,

Entity-relationship (E-R) and Unified Modeling Language (UML) diagrams

Using normalization rules and principles to create properly-designed databases,

Basic database administrator objectives and tasks,

Understanding the role of data warehousing and data mining

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