Quality Assurance Assistant

FUNKE ABIOLA

202-***-****; email: ******@****.*****.***

EDUCATION

UNIVERSITY OF PENNSYLVANIA Philadelphia,

PA

Masters in Biotechnology, May 2010 GPA: 3.6/4.0

LAGOS STATE UNIVERSITY Lagos, Nigeria

Bachelor of Science in Microbiology, August 2007

GPA: 3.2/4.0

WORK EXPERIENCE

CHILDREN'S HOSPITAL OF PHILADELPHIA (CHOP) Philadelphia,

Dept of Pediatrics/Genetics, Abramson Research Center PA

Research Assistant Sept 2009 -

present

Investigating the Role of mutX in Competence Regulation and Transcriptional Errors in

Streptococcus pneumonia colonization of the upper respiratory tract.

Site-directed mutagenesis, Molecular Cloning, in vivo bacterial gene expression and

genetic transformation assays, Use of Genetic Markers, Genetic screening in budding

yeast (yeast-two-hybrid system)

Restriction enzyme digestion, Primer Design, PCR, DNA sequencing analysis,

Fluorescence and Bioluminescence assays.

Protein purification, identification and quantification (Bradford pull-down assays,

SDS-page gel electrophoresis & Western blot analysis) and cell culture techniques

SHIRE HUMAN GENETIC THERAPIES Inc. Lexington, MA

Clinical Research Associate (CRA) Intern

Jun - Aug 2009

Created Study Trackers including regulatory documents, patient enrollment and visit

trackers, created trackers for CRA monitor visit dates, reviewed safety and adverse

events (SAEs) reports

Migrated clinical site files, Trial Master Files (CTMF), and other study documents

into EDMS repository for auditing and submissions,

preformed quality checks routinely

Developed clinical trial study design strategies, implementation, regulatory

documentation and timelines

Contributed to site and drug supply logistics and overall clinical project management

Prepared Letters of Agreement and grant applications, including tracking, organizing

and e-filing of grant submissions

Supported Clinical Program Director and Clinical Operations Manager with development

of clinical study budget

Demonstrated good understanding of SOPs, ICH, GCP and other regulatory guidelines

Provided support to the Clinical Team including Program Director, Project Managers

and CRAs on clinical study programs

Provided timely and accurate documentation of clinical team meeting agendas and

minutes

UNIVERSITY OF PENNSYLVANIA SCHOOL OF MEDICINE Philadelphia,

Research Assistant, Department of Psychiatry PA

Feb 2009 -

present

Assist with cancer study recruitment, survey interviews, data collection, data entry

and quality assurance

Analyze survey results of patients and high-risk individuals with breast, colorectal

and prostrate cancers

Conduct literature searches and reviews across multiple studies

Consent participants and conduct brief counseling sessions

WISTAR CANCER INSTITUTE Philadelphia,

Cancer and Stem Cell Research Assistant PA Feb - May

2009

Basic research in melanoma, with focus on reprogramming melanocytes and melanoma

cells into induced pluripotent stem cells using

the Notch pathway.

Histological staining and analysis of skin grafts. Isolation of plasmid DNA, cDNA and

RNA. RT-PCR techniques

Scientific communication, writing and interpretation of research results of

laboratory work and academic literature

PENN BIOTECH GROUP CONSULTING (PBG) Philadelphia,

Wharton Business School, University of Pennsylvania PA Jan - May

2009

Student Consultant: Becton Dickinson (BD) & Co.

Developed strategic proposals to assess regional anesthesia procedures and created

avenues for optimization and modification of spinal needle trays. Explored unmet

market needs, size and potential for use of BD spinal anesthesia needles

Analyzed business plans for potential growth to convert the unmet needs in this areas

into profitable market opportunity

PFIZER NIGERIA Lagos,

Intern Nigeria

Oct - Dec

2005

Performed microbiological quality control and assurance of pharmaceutical raw

materials and finished products using strict cGLP and cGMPs guidelines

Completed full internship program rotation in manufacturing of pharmaceutical

products within the pipeline

Performed routine bioburden and endotoxin testing of pharmaceutical products and raw

materials under aseptic conditions

Performed water sampling and environmental monitoring of the manufacturing areas.

COMPUTER SKILLS

Microsoft Word, Excel, PowerPoint, Publisher, Outlook, MacVector Software

LEADERSHIP AND EXTRA-CURRICULAR ACTIVITIES

National Society of Black Engineers (NSBE)

International Society of Pharmaceutical Engineers (ISPE)

Contact this candidate