Quality Assurance Control

Summary

A warm, kind-hearted, and dependable worker seeking employment as Quality

Assurance Specialist.

Skills

. GLP, cGMP and SOP trained.

. Formatting letters, templates, spreadsheets and documents.

. Familiar with scientific terminology.

. Ability to perform quality control (QC) review of documents for

completeness, accuracy, legibility, etc.

. Familiarity with electronic document management systems

. Ability to interact effectively with all departments.

. EXPERIENCE WITH DOCUMENT CONTROL PROCESS (REVIEWED BATCH RECORD INDS AND

NDA) (regulatory agency forms).

. Good organizational, planning and time management skills.

. Good general administrative skills setting up and maintaining paper and

electronic filing systems.

. Knowledge of Regulatory Affairs forms (INDs, NDAs and ICH guidelines,

SAE (serious adverse event) reporting.

. Skilled in document handling, with proficiency with MS office

applications including MS Excel, Word and PowerPoint

. Knowledge of FDA safety reporting requirements

. Excellent communication and people skills.

. Detail oriented with the ability to multitask in a fast paced

environment.

. Knowledge of Photoshop CS3, some Adobe Acrobat, Web Design (Basic HTML)

. Trilingual (English, French, & Italian)

Work History

(Please note: Interruptions in employment are due to education and personal

obligations that are now fulfilled.)

Profil Institute of Clinical Research: Quality Assurance Assistant

11/08- 9/09

. Assisted the Director of QA in the administrative tasks of managing

the Quality Assurance Department.

. Provided general QA support including but not limited to: keeping

medical licenses, job descriptions and CV's up to date, updating the

archive database

. Supported with the writing and maintenance of Work Instructions,

SOP's and standardized forms

. Assisted with management and maintenance of medical equipment

. Assisted with maintenance and use of QA software applications

. Performed Intenal Audits

. Assisted with the maintenance of Profil quality certifications

. Assisted with staff training and maintenance of associated logs

. Assisted in creating and monitoring training plans

. In cooperation with and under the leadership of Quality Control

Specialist, developed an understanding of monitoring clinical trials

to the point of being able to monitor trials independently.

Biomedical IRB: RA Intern/ Clinical Research oversight trainee (PT)

5/2008- 7/2008

. Document Control process for regulatory files such as IND, NDA, SAE,

and MedWatch. (Receive, Scan, Load, Review, Approve and Fax)

regulatory forms to biotech, medical device and pharmaceuticals.

. Invoicing checks, filing.

Floor Proctor for California Western Law School & State Bar

7/2005 - 4/2008

. Responsible for monitoring students during their finals/State Bar

Stability Analyst (3-month temporary assignment) for Amylin Pharmaceutical

12/2005-2/2006

Documentation Specialist/QA-associate

. Assisted stability group with the backlog of stability programs

maintenance

. Participated in data archival, stability study terminations, invoice

processing, data tracking and distribution

. Gained knowledge of HARBOR and WAVE

. Trained in cGMP and SOPs

. Assisted group in maintaining and controlling master documents,

regulatory files, training documentation

. Initiated Nonconforming Report and coordinated the appropriate follow

up

. Reviewed completed documents for final QC approval

. Generated summary packets (data) of stability studies and general

quality systems

. Conducted clerical duties such as: copying, scanning batch related

documents, filing, organizing, and assembling manufacturing binders

Multiple Positions for San Diego State University 9/1998 -

7/2001, 10/2002 - 12/2002

Roles included:

. Student Assistant for SDSU Foundation, Joint Doctoral Program in

Clinical Psychology

. Lab technician for Chemistry Department SDSU

. Mentor for Summer Bridge Program (physics, chemistry, biology)

.

Education

San Diego State University, San Diego, CA

5/2003

. Bachelor of Science in Chemistry

Minors in Computer Science and Italian

. Environmental Hazwoper Certification (OSHA)

San Diego State University, San Diego, CA

2006- Present

. Advanced Regulatory Affairs Certification at SDSU

Internships

Enviro-Matrix Analytical, San Diego, CA

Chemistry Intern

1. Performed sample analysis using (TCLP, EC, TSS, VDS, STLC, pH

calibration

2. Assisted in the analysis of total alkalinity, nitrite, and nitrate tests

SDSU Chemistry Research, San Diego, CA

Research & Chemistry Assistant

Multiple Internships via SDSU. Responsibilities included:

. Analysis and Effects of Cotinine

o Used (LC/MS) to analyze the environmental effects of inhaling

cotinine on non-smokers

3. Prepared buffers and solutions for labs

4. Assisted professors in troubleshooting equipment problems and grading

lab experiments, tests, and exams

5. Conducted instrumental lab experiments for students to ensure its cost

effectiveness in classroom setting

Contact this candidate