Quality Control Testing
Resume:
Kara Byrne
Dracut, MA *****
******@*****.***
SUMMARY
Experienced research associate with diversified background in Assay Development, Validation, QC release
testing and clinical trial testing. Highly goal orientated, dedicated and organized team player with extensive
experience in GMP/GLP/CLIA environment.
WORK EXPERIENCE
Pfizer (PGS) Andover, MA
Quality Control Scientist II
Quality Control Analytical April 2012 – present day
• Skilled in a variety of cGMP analytical techniques ELISA, gel electrophoresis, HPLC SEC, CEX, Appearance /
color / clarity testing, Karl Fisher Moisture protocol, UV-VIS spectrophotometry methods
• Authored, revised and approved Sops, scientific memos and laboratory methods via PDOCs
• Validated and qualified new methods including ELISA, HPLC, instrumentation and testing protocols
• Participated in method transfers from internal Pfizer sites and external contract sites
• Performed both quantitative and qualitative testing in support of raw materials, drug product and drug
substance materials, stability and in-process release testing in compliance with cGMP standards
• Managed global shipping program in support of internal and external requests for in process and commercial
materials including drug product, drug substances and reagents
• Completed review and authorization of raw data and in process testing
• Supported daily operational tasks including instrument calibration, maintenance, validation
• Completed Method One (M1) Training and HER Training
Relevant Computer Programs: PDOCs, Labware Lims, Power2Learn (P2L), Plateau Learning Portal, QUN2 systems,
Empower, SAP, share-point, Leanlabs, JMP, Leveler, Microsoft Office Programs, Graph Pad Prism
Sanofi / Genzyme Corporation Framingham, MA
Research Associate / Technologist II
Clinical Immunology / Specialty Chemistry June 2009 –March 2012
• Skilled in ELISA, RIPS, western blots and immunoturbidimetric assays in support of clinical testing
• Experienced with fluorescence / UV-VIS spectrophotometer, Mass Spectrometry and Meso-Scale Discovery
platforms
• Assisted in the validation and optimization ELISA based assays to be transferred to MSD Platform improving
sensitivity and precision in support of biomarker testing
• Prepared calibrators, controls and raw materials sufficient to complete several phase II-III clinical drug trials
and coordinated the clinical sample handling and testing
• Participated in setting up, completing and analyzing clinical drug studies including both PK/PD testing
• Directed, coordinated and tested clinical samples in accordance with internal and external deadlines
• Generated technical reports in support of assay validation and in-process reports for clinical data testing
• Redesigned and upgraded existing clinical testing database
• Developed and amended SOPs according to GMP, GLP and CLIA standards
• Lab Safety Officer (LSO); monitored chemical inventories and hazardous waste satellites to meet federal and
state standards and disseminated safety information to employees during monthly meetings
• Wrote and implemented Job Risk Assessments (JSA)
• Member of Quality System Team; participated in internal and external audits including FDA
• Served as Chemical Safety Officer (CSO) responsible for maintaining and implementing specific GMP
standards for chemical storage and safety, and ensuring that laboratories were maintaining safe chemical
storage and usage in accordance with GLP and GMP standards
COMPUTER SKILLS
Skilled in Microsoft Office Programs: Excel, Word, Powerpoint, Outlook, Windows 95, 98, 2000, Filemaker, Softmax,
Pipeline Pilot, Lims, Multi-QC, Lpro, Plateau and Livelink
AWARDS
Corporate Spot Award for participation and completion of Phase II clinical trials
Professionalism Award
Communication Award
Thermo Fisher Scientific / Pierce Biotechnology
Lead Research Associate/ QC Analyst
Searchlight Commercial Service Woburn, MA September 2006 – May 2009
• Assigned and delegated laboratory responsibilities including daily laboratory work, equipment maintenance,
sample testing and data review
• Supervised the testing, data analysis and daily laboratory tasks for 5 medical technologists
• Created and revised SOPs pertaining to clinical testing procedures, lab equipment and quality control
procedures
• Trained personnel to ensure compliance with SOPs
• Maintained and updated computer databases containing client information and daily testing
• Conducted routine and non routine testing of raw materials, bulk reagents and finished kit products making
use of biochemical techniques such as ELISA, liquid chromatography and BCA testing
• Identified and resolved issues in multiplex panels by performing cross reactivity studies and titrating down
antibodies and assay buffer reformulation
• Purified polyclonal antibodies from bleeds to create an inventory of raw materials for sample testing
• Performed ruthenium labeling and biotinylation of antibodies to test different ELISA assay formats
• Executed the formulation of reagents for an immunoturbidimetric assay using gold nanoparticles suitable for
testing in analytical chemistry analyzers
• Developed, validated and optimized new ELISA testing formats in support of new biomarker and cytokine
products
• Assisted in the automation of manufacturing and QC procedures to improve human errors or bias
• Supported facility's environmental monitoring programs in compliance with CLIA / GLP standards
• Performed Bioburden and Endotoxin testing on in house products and water samples
• Inspected kits verifying labels, manufacturing batch records and client records
• Completed real time and accelerated stability testing
• Oversaw the maintenance of laboratory equipments including Tecan, Randox Daytona, plate washers and
Hydra DT
• Performed clinical laboratory testing on various sample matrices and species
• Completed data analysis using various computer programs including Microsoft Excel, Microsoft
• Outlook, EzCruncher and Search Light Array-Analysts
• Supported the maintenance and compliance of GLP/CLIA system for company
COMPUTER SKILLS
Skilled in Microsoft office, Excel, Word, Searchlight Array Analyst, Ez Cruncher, Lpro, Array Analyst Imager,
EDUCATION
2003-2006 University of Massachusetts, Lowell
Bachelor of Science (BS)
Major: Biology with concentrate in biotechnology
Minor: Economics
Dean’s List member
Summa cum laude
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