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Quality Assurance

Location:
Goldsboro, NC
Posted:
September 15, 2015

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Resume:

Camilla R. Bowman

*** **** ******* ****** ********* J

Goldsboro, North Carolina 27534

Mobile: 301-***-****

E-mail: acrpa5@r.postjobfree.com

PROFESSIONAL GOAL

I will like to acquire a challenging career with a successful organization or company utilizing the opportunity to offer proven and developing skills within the company.

EDUCATION

University of Maryland University College College Park, Maryland

Pursuing a Master’s of Science in Biotechnology: Regulatory Affairs (18 credits) September 2014-present

Morgan State University Baltimore, Maryland

Bachelors of Science, Biology May 2005

Oxon Hill High Oxon Hill, Maryland 20745

High School Diploma (Science & Technology Program) May 2000

EXPERIENCE

A-TEK Washington, D.C.

Molecular Biologist January 2013-January 2015

Handle, receipt and process operational, Quality Assurance, and proficiency.

Perform non-research biological science work utilizing microbiological and molecular techniques, including DNA extraction and real-time polymerase chain reaction (PCR), to identify and characterize pathogenic bacterial and viral agents.

Perform DNA extractions using the vacuum and single tube methods.

Prepare reagents and samples and maintain chain-of-custody (COC).

Interpret results and enter data owned by the state/local public health laboratory into computer-linked systems (LRN RM, BLaDE, SMS/DMS).

Perform equipment maintenance and calibration.

Collect, process and analyze internal laboratory swipes/swabs for Quality Assurance/Quality Control (QA/QC)

Autoclave and/or dispose of bio-hazardous trash.

Restock and inventory supplies, QA/QC of reagents in accordance with Standard Operating, and provide training on BioWatch protocols and procedures for new personnel/retraining requirements.

Adhere to CIA/QC requirements in accordance with Public Health Laboratory quality management systems and the BioWatch Laboratory Quality Assurance Program Plan (QAPP).

Archive samples and perform daily functions and internal proficiency tests and successfully pass external proficiency tests and audits as defined by Department of Homeland Security (DHS) in the QAPP.

Analyze daily external QA samples in accordance with BioWatch SOP’s and QA program guidance for screening and confirmatory assays.

Demonstrate ability to follow and adhere to written procedures and accepted practices in accordance with federal and state guidelines

Prepare written and oral technical reports, answer questions, and troubleshoot equipment and reagent issues.

Accurately perform work with confidence and demonstrate competency in various testing methodologies and meet established deadlines.

Gene Logic Gaithersburg, Maryland

Quality Assurance Associate August 2008- March 2012

Perform various scientific procedures in a BSL-2 level laboratory.

Team leader for a group of 10 laboratory personnel.

Perform cDNA synthesis, in vitro transcription.

Purify cDNA and nucleic acids by using various purification methods.

Analyze results using Gel Electrophoresis, Agilent Bioanalyzer 2100 (Nano and Pico), and spectrophotometry.

Perform RNA and DNA extractions using various extraction methods (manual and automated).

Handling and proper disposal of various hazardous materials.

Train other scientists and technicians in RNA/DNA handling techniques and assay protocol.

Conduct operational audits according to client expectations and/or company SOPs.

Conduct internal facility and/or study related audits to identify non-conformities in adherence to SOPs, regulations, protocols, and expectations for data accuracy and completeness.

Review analytical data for in-process and finished products.

Assist with hosting client and regulatory audits to ensure that guest auditors receive access to needed documentation and staff with minimal disturbance to ongoing operations.

Construct and revise tables and charts to track and gage the budget expenses for various contracts to assist the account manager’s with assimilating monthly budget reports.

Establish and or change timelines; set acceptance criteria; monitor change control progress and obtain approvals for projects; update management and customer with project status.

Review responses to inspection reports and performs follow-up with respondents, management, or others, if needed.

Keep record of documents, reagents, and samples.

Prepare batch records that include assay data and analysis results and present results in weekly meeting when needed.

Assist the archivist with archiving SOP’s, important documents, and samples from GLP projects.

Review final study reports to assure that such reports accurately describes the methods and standard operating procedures, and that the reported results accurately reflect the raw data of the study as in compliance with GLP requirements.

Track samples, data, and documents using various tracking systems

Assure that deviations from approved protocols/study plans or SOPs are made and use corrective and preventive action (CAPA) recommendations.

Research, collect data, and compose a report for different equipment and techniques that are more cost efficient.

Increase daily work productivity and the overall efficiency by introducing processes and procedures that eliminates duplication and reduces time to complete projects.

Train other scientists and technicians in RNA/DNA handling techniques and assay protocol.

Create, review, approve, and distribute, batch records, forms, and reference documents maintained as controlled documents.

Collect, correct, and review raw data in accordance with Good Laboratory Practice (GLP) documentation requirements.

Conduct inventory management and experimental data information using a Laboratory Information Management System (LIMS).

Help organize and participate in Organizational Development intervention activities.

Troubleshoot various assay and machinery performance issues.

Monthly maintenance and calibration on various laboratory equipment and pipettes.

Ensure all laboratory machines have been calibrated and upkeep of laboratory log books and experimental records.

Order supplies and maintain an inventory system to keep sufficient supplies for laboratory and office.

Naval Medical Research Center Silver Spring, Maryland

Research Associate II July 2005 - August 2008

Perform daily operations in a BSL-3 level laboratory.

Prepared master mixes and other materials for the critical reagents program.

Functions in a supervisory role with respect to work assignments and scheduling for a group of six.

Liable for production, data analysis, and quality control of laboratory reagents and specimens to be sent to

classified sponsors.

Perform real-time Polymerase Chain Reaction (PCR) and ELISA testing based diagnostics for confirmatory

testing on the DNA sequence of a particular biological agent.

Execute manual DNA extractions.

Use molecular and cell biology techniques to perform assay optimization and prepare assay reagents.

Interact with various scientists to aid in the molecular probe development.

Troubleshoot and resolve moderately complex problems with equipment or individual assays.

Support with custom robotic PCR and PCR clean-up reactions and use established quality control procedures.

Participated in the Multiple Center Evaluation comparing sample processing methods for nucleic acid

extractions.

Assist in preparation and teaching class of enlisted military personnel working in biological warfare

environments for Biological Warfare reagent detection and analysis via Polymerase Chain Reaction (PCR) and

ELISA protocols and techniques.

Prepare and supply Navy fleet with reagents for BW detection/analysis as well as other consumable.

Evaluate monthly Quality Control tests given to Navy fleet to ensure competency and readiness in response to a

potential BW attack.

Provide training and technical leadership to less experienced staff.

Implement, revise, and create Standard Operating Procedures for PCR reagent and DNA production.

Organize and produce graphs and reports for various laboratory assays.

Responsible for ordering all laboratory supplies.

Handling and proper disposal of various hazardous materials.

Familiarity with sterile lab technique, scientific, and safety ethics.

Completed Health Insurance Portability and Accountability Act (HIPAA) training.

Received “Secret” level security clearance.

AWARDS AND HONORS

Outstanding Annual performance review, A-Tek, 5 star rating out of 5, 2013-2015

Outstanding Performance Award, Gene Logic, 2008-2011

Civilian of the Quarter Award for April-June 2007, Naval Medical Research Center, Molecular Diagnostics, BDRD

TRAINING AND CERTIFICATIONS

Safety Lab Training Safety and Health-Bloodborne Pathogens certifications, Industrial Safety Hazard Communication, C.B.R.N.E certification, Hazmat Awareness/Operations certification, Real-Time PCR Training Certification, GLP Training and Certificate, and Quality Assurance Training certificate.

REFERENCES AVAILABLE UPON REQUEST



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