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Quality Control Maintenance

Location:
Alexandria, VA, 22304
Salary:
80000
Posted:
September 08, 2011

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Resume:

Timothy James Blaszkow

**** ******** ** *** ***

Alexandria VA, 22304

703-***-****

Email: ********.*@*****.***

Experience:

Quality Control Analyst, Meso Scale Diagnostics

June 2010- Present

• Collecting Quality Control data and developing templates to analyze data using statistical techniques, visual techniques, and various other analytical methods

• Conducting Quantitative cytokine, phosphoprotein, and biomarker ELISA style sandwich assays

• Conducting Quantitative and Qualitative analysis of In-process and stability samples of diluents, raw materials, micro-plates, and other materials

• Conducting quantitative and qualitative biological and chemical analyses of materials and reagents

• Implementation of ISO and cGMP controls in a bio-pharma environment

• Managing Process Improvement and Product Development projects from conceptualization through completion while actively communicating status updates throughout the course of the project to upper management

• Producing technical reports to present in interdepartmental meetings to discuss the results of root-cause failure analysis of non-conforming materials, involving analyzing data developing a clear and concise presentation of the information, as well as presenting the analysis to department heads and directors using Microsoft Powerpoint.

• Initiating and conducting CAPA investigations on Non-conforming materials and Out of Specification testing

• Instrument maintenance including Calibration, Daily Diagnostic Testing, Weekly Performance Qualification Testing, and Monthly Maintenance on Micro-plate Readers and Plate Washers

• Conducted Testing for bridging of reagent and plate lots including the statistical analysis of inter-lot signal variability

• Experience in developing and updating databases and summaries using Microsoft Office Suite to maintain accurate records of QC data and testing (Microsoft Access and Excel)

• Developing interdepartmental procedures and documents associated with procedures including SOPs, Forms, and Flowcharts

• Trained to work in BSL-1 and BSL-2 environments

• Conducting peer review of test records, documents, and Materials Verification Forms

• Assisting with batch record paperwork for testing for Kit lots, Plate lots, and new Detection Antibodies

Education:

Virginia Polytechnic Institute and State University (Virginia Tech)

B.S. Biology, December 2009

• Graduated in 3 and a half years

• Course work included quantitative courses such as Biostatistics, Chemistry, Physics, Freshwater Ecology, and Environmental toxicology

• Qualitative course work including insect biology, microbiology, and general biology

• Preparing independent and collaborative research reports

• Conducting experiments based upon defined procedures as well as developing procedures to test original research

• Presenting research findings to classmates, professors, and members of the university research community using Microsoft Powerpoint

Skills:

• Highly developed skills using Microsoft Office Suite products (Microsoft Office, Excel, Powerpoint, Access, and OneNote)

• Ability to conduct quantitative and qualitative analysis of data provided in multiple formats

• Conducting statistical analysis using common statistical techniques

• Collecting, reformatting, and analyzing data in formats that are conducive to creating reports, presentations, and able to easily be interpreted to determine status of material

• Operating in cross-functional groups and presenting information to cross departmental committees

• Operation, Calibration, and Maintenance of various laboratory equipment and apparatus

• Operation in accordance with cGMP principles



Contact this candidate