Assistant Quality Control

SIGITA BURKE

** ****** ****, ********* ** *****-*596

610-***-****, *********@*****.***

EDUCATION

West Chester University of Pennsylvania, West Chester, PA

Bachelor of Science in Pharmaceutical Product Development, Minor in

Biology; September 2008 - December 2010

RELATED COURSEWORK/STUDIES

Delaware County Community College, Media, PA

Natural Science; July 2007 - August 2008

Kaunas University of Medicine (Lithuania)

Public Health; September 2002 - October 2005

Kaunas College (Lithuania)

Nursing; September 2000 - July 2002

EXPERIENCE AND PAST EMPLOYMENT

Regulatory Affairs Assistant - ViroPharma Incorporated, Exton, PA

October 2008 - January 2011

. Led project to create software for storing and providing easy access

to regulatory information. Created the design, performed validation,

testing, and proposed solutions for improvement. Collaborated with IT

group and led status meetings to meet project timelines

. Supported various regulatory submissions IND, NDA, BLA, APLB, DDMAC

. Developed working instructions for regulatory submissions of

promotional materials to APLB and DDMAC

. Reviewed labeling and promotional material for compliance with local

and global regulations

. Generated responses to FDA letters, supplements, and amendments

. Ensured that regulatory submissions, labeling and promotional material

meet corporate and departmental standards

. Compiled electronic regulatory documents according to regulatory

requirements

. Researched US and global regulatory regulations

. Maintained regulatory files in a format consistent with requirements

. Document filling, archiving and paper submissions publishing

Bottom of Form

Study Support Specialist - ICON Clinical Research, Vilnius, Lithuania

May 2010 - August 2010

. Translation and verification of various forms and documents from

English to Lithuanian and Lithuanian to English

. Electronic document filing and organizing

. Quality Control tasks

Pharmacy Technician/Triage Technician - Heartland Pharmacy, Allentown, PA

June 2008 - September 2008

. Prescription filling for nursing homes

. New patient triaging, data entry

Chemistry/Biology Tutor and Lab Assistant - Delaware County Community

College, Media, PA

February 2008 - June 2008

. Assisted students with their homework for various chemistry and

biology classes

. Laboratory preparation for experiments

Pharmacy Assistant, Boots The Chemists (Bristol, United Kingdom)

August 2006 - June 2007

. Prescription filling, data entry, pharmacy stock order management

Nurse's Assistant, The Worthies Care Home (Bristol, United Kingdom)

October 2005 - August 2006

. Distribution of medications, personal patients care, breakfast

preparation and supervision

SKILLS

Fluent in English and Lithuanian, advanced skills in Adobe PDF and

Microsoft Office programs, excellent analytical, research and problem

solving skills, strong attention to detail, excellent communication,

collaboration and team work.

References available upon request

Contact this candidate