Training Quality Control
Resume:
Alesha Patterson
Middle River, MD 21220
**.******@*****.***
PROFILE:
[pic]
OBJECTIVE: To obtain a position on a team that will utilize my trouble-
shooting skills, technical knowledge, documentation control and strong work
ethic in a customer-oriented field.
SUMMARY: Strong technical background and expertise from research and assay
development experience, as well as experience with external and internal
customer training/audits from working in an assay transfer group.
SKILLS:
[pic]
FDA 21 CFR 820
ISO 13485, 9001 (Logistics)
GMP / GLP
Amplification
Recombinant DNA Techniques
Nucleic Acid Isolation and Purifications
Electrophoresis
HPLC
PC and MAC based platforms
Microsoft Office Suite: Word, Excel, Access, and PowerPoint
NextGen Platform (HC400 / JE2000)
careHPV System
Qiagen BioRobot 3000 / 8000 / Universal
Qiagen M48 and BioSprint 96
Packard Multiprobe II
ABI 3130 Capillary Sequencers
ACCOMPLISHMENTS:
[pic]
I was working on a project that was on a strict timeline. It was my
responsibility to process interfering substances with one of Qiagen's ELISA
assay. At that time, the company had never ordered whole blood and the
entire process would take almost a month to accomplish. I had a friend that
worked for a phlebotomist and because I knew my HIV status, my blood would
be ideal to use. The company would have known HIV (negative status) blood
within an hour for free. Not only would I be saving the company money, I
would be also saving the timeline as well. Therefore, I discussed my plans
with my supervisor and I was able to accomplish my task in less than one
hour.
PROFESSIONAL EXPERIENCE:
[pic]
EXPERIENCE:
Meso Scale Diagnostic, Quality Control Analyst II June 2012 -
October 2013
. Responsible for writing and verifying Certificates of Analysis.
. Assisted with transformation of R&D assays to QC through documentation
management.
. Record keeping of daily data analysis through Batch Record Review
which included daily updating of QC databases.
. Anchoring of incoming antibodies and QC of manufactured reagents under
GMP guidelines.
. Development of logical automated data analysis templates and scripts.
Qiagen Inc., Systems Integration Scientist II October 2010 -
December 2011
. Developed an in-house reliability plan to improve instrument
reliability for 1-2 months.
. Responsible for IQ, OQ, PQ of several engineering instruments; by
monitoring, measuring, and recording of data.
. Support Systems Integration to resolve remaining instrument
performance variability problems by writing reports to identify
performance issues and resolution for V&V.
. Independently determine root cause of instrument failures and document
diagnostic and repair techniques by internal and external audits.
Qiagen Inc., R&D Scientist II April 2009 - October
2010
. Responsible for coordinating and supervising the training of internal
scientists on Qiagen's NextGen HPV platform instruments.
. Development and troubleshooting of the NextGen Reflex Assay chemistry
in a shortened timeline (2 months).
. Conducted and executed environmental testing on the NextGen system
(HC400) through ISO 9001 audits.
. Suggested and implemented a self-sampling and donor program for cost
saving experiments on interfering substances.
. Played an instrumental role in the Employee Satisfaction Task Force.
Digene Corp / Qiagen Inc., R&D Scientist I January 2007 -
April 2009
. Responsible for writing, reviewing, and revising SOP's and internal
reports.
. Summarizing and presenting experimental results in cross-functional
team meetings Meticulous and clear recording of all study findings for
future references by project teams.
. Developed and implemented recovery of nucleic acids and protein from
formaldehyde scavengers, patent pending.
. Part of a cross-functional team that performed a variety of sample
preparation and analysis procedures as well as troubleshooting the
chemistry to produce the current Pre-Analytic platform chemistry for
the NextGen HPV test.
. Developed and implemented careHPV system while improving
lyophilization process for reagents.
. Part of a two person team responsible for training technicians in
Rwanda, Africa for a Clinical Trial using the careHPV system; testing
2600 women.
. Training included both assay chemistry and instruments used for the
assay as well as internal and external audits.
. Responsible for Regulatory Compliance for Rwanda Trial.
Gene Logic Inc., Research Associate November 2005 - January
2007
. Developed and implemented one of the largest Affymetrix 500k chip
processing facilities in the country.
. Genomic DNA isolation from blood, tissue, and FFPE as well as QC by OD
and picogreen.
. Wrote and implemented SOP's and new nucleic acid isolation and
extractions in support of the genomics production group becoming GLP
compliant for larger scale contracts.
. Supervised and trained junior members in proper RNA isolation
techniques both manual and automated; including stabilization,
crushing, organic extraction, isolation and QC by Agilent Bioanalyzer.
. Identified and helped to develop cost saving and labor reducing
technologies to help streamline and improve production facility
processing.
. Examples include processing tissue by way of Qiagen's BioSprint 96 and
processing blood by Qiagen's Paxgene 96.
St. Louis University, Research Assistant July 2000 -
October 2005
. Responsible for implementing new methodologies for genetic
abnormalities in neoplasm.
. Participated in the development of the DNA LAB becoming CAP / HIPPA
regulated.
. Support of the hospital outlook of HIPPA regulations.
. Physician support by calling and assessing proper diagnostics on stat
test as HCV quantization and HSV typing and client billing.
. Responsible for ordering supplies and tracking supply budget.
. Help detect characteristic gene rearrangement and the activation of
specific oncogenes; from DNA extracted from tissue and FFPE.
EDUCATION AND TRAINING:
[pic]
BACHELOR OF SCIENCE: BIOLOGY
Wilberforce University, Wilberforce, OH
Dean's List, Fall 1997 - Spring 2000
NASA Solar Training Program Spring 1998
Short-Term Training Program to Increase Diversity in Health-Related
Research (STREAMS) Summer 1999
MASTER OF SCIENCE: ENGINEERING MANAGEMENT
Drexel University, Philadelphia, PA
Managerial Communications
Economics for Engineering Management
TECHNICAL PUBLICATIONS:
[pic]
Enhanced Sulfur Removal of Coal via Carbon Fiber Production
U.S. Department of Energy, Office of Fossil Energy DE-FG22-96PC9622-01
Herbert Smitherman; Edward Asikele; Delbert Buffinger; David Griffith;
Osagie Evbuoma; Alesha Patterson
HPV screening using careHPV Test on a high-risk HIV population in Kigali
Township, Rwanda
Paul Eder, Eugene Mutimura, Alesha Patterson, Niwashin Shrestha, Laura
Bell, Eric Payne, Holly Basham, P Mulindwa, E Rugigana, Kathrine Anastos
QIAGEN, Inc. Gaithersburg, USA; Women's Equity in Access to Care and
Treatment and Kigali Health Institute, Kigali, Rwanda; Central Hospitalier
Universitaire de Kigali and National University of Rwanda, Kigali, Rwanda;
School of Public Health, National University of Rwanda, Kigali, Rwanda;
Montefiore Medical Center and Albert Einstein College of Medicine, Bronx,
USA
Contact this candidate