Quality Assurance Customer Service

Jaymie Hu

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

EDUCATION:

University of California at Los Angeles December 2006

Major: Bachelor of Science in Biochemistry

Career Objective

To obtain a Quality Assurance/ Bio-Tech or Pharmaceutical Company

Career Profile

QUALIFIED CLINICAL RESEARCH ANALYST /Quality Assurance BIO-TECH

Professional offering a strong educational background in biology, Two years experience in assisting clinical study protocol, clinical study report and study agreement. Monitoring study process such as patient recruitment and safety compliance and collecting study data listing. Follow details study guidelines and ensure medical input is within normal range. Interpret data and possible consequences for bias medical results. Recommend choice of study placement and participate in negotiation. Two and a half years experience in quality assurance and regulatory compliances for food dietary supplement/pharmaceutical raw material. Familiar with cGMP and FDA standards. Approve Certification of Analysis and SOP for internal audit. Choose qualified raw material vendor according to company’s program. Strong analytical skills to interpret lab and clinical data

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

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 STP’s SCP’s and general Working Instructions

Preparation of vendor assessment program.

Vendor approval

Ensuring the documentation as per ISO and FDA requirement.

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

Entry Network Technician, ITIL V3

Regulatory affair certification emphasis pharmaceutical completed in 2011

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

PERSONAL EXPERIENCE AND INTEREST:

Volunteer in Emergency Room and Patient Relations April 2006 - March 2007

University of California at Los Angeles Medical Plaza Handle and resolve patient complaints to improve hospital public image

Maintain and enter patient complaint data for future analysis to improve

customer service and relations

Member of Biology Club Sept. 2004 - March 2007

University of California at Los Angeles

Arrange and plan monthly meetings for community service activities

Participate in local community service activities that focus on environmental issues,

such as global warming and canbon emission

Contact this candidate