Quality Assurance Maintenance
Resume:
M elissa E. Bruner
Bloomington, MN 55431
E-mail: ****.******@*****.***
Cell: 612-***-****
Education:
June 2012
University of Minnesota Graduate School
University of Minnesota-Twin Cities, Minneapolis, MN
• Degree: Master of Biological Science
• Thesis: “ Only Genetically ‘Pure’ Humans Found in Africa; Neanderthal Genes
still Found in the Rest of us”
December 2006
U niversity of Minnesota
U niversity of Minnesota-Twin Cities, Minneapolis, MN
• Degree: Bachelor of Arts Anthropology
• Minor: Biology
Work Experience:
April 2012-July
WuXi AppTec
2014
2540 Executive Drive
St. Paul, MN 55120
Genetic Toxicology Study Di rector
• Responsible for the scientific and administrative aspects of all studies taking place in the Genotoxicology
l aboratory
o Wrote standard and custom assay protocols, IACUC protocols, SOP’s, amendments, deviations,
l aboratory investigations, CAPA’s, final scientific reports, FDA response memos, and genetic
toxicology presentations.
• Confirm and coordinate compliance with regulatory bodies specific to the clients marketing needs and project
specifics (GLP, GMP, ICH, FDA, OECD, ISO, EU-ISO, JMHLW, and more)
• Communicated study updates, amendments and deviations during the study, and worked with clients to
submit final reports as part of a PMA or 510K submission
• Flexed into laboratory to train others on new protocols and procedures, as well as f lexed into the laboratory as
needed
o Cell culture maintenance and banking, cloning, environmental sampling, IV and IP injections,
animal observations, hemocytometer use, chromosomal aberrations, microscopic analysis, assay and
technician scheduling, supply ordering, and other general laboratory procedures
• Part of a core team implementing electronic data capture software (scope, gap analysis, risk analysis, test
cases, validations, and process mapping)
• Initiator of both site and companywide process improvement and process implementation (MS work and Excel
templates, scheduling process changes, spreadsheet validation and implementation, lean 6 sigma projects,
and more)
• Sent out samples to other CRO’s and acted as study monitor on behalf of clients (ordered assays, approved
and signed protocols, approved deviations and amendments to study design, scientifically reviewed and
accepted final reports)
• Remained current on the genetic toxicology literature via scientific journals and attending scientific
conferences
o Member of and participation in the Environmental Mutagenics and Genomics Society
o Member of the Genetic Toxicology Association
April 2006- August
Vi romed Laboratories
2011
6101 Blue Circle Drive
Minnetonka, MN 55343
Clinical Vi rology, M icrobiology and T issue Cultu re Technologist
• Ran Assays in a FDA regulated Laboratory using GLDP, GMP, and GCP
• Elisa and Sandwich Assays, PCR Assays, Blot assays, Microarray Assays, Microscopic Evaluation, gel
electrophoresis, and other general assays
o Experience (techniques): cell line maintenance and banking, gram staining, plasmids, reporter genes,
various types of columns, cloning,
o Experience (equipment): Pipettes, micropipettes, centrifuges, incubators, Bac-T, Thermal Cycler, light
and f luorescent microscopy,
• Quality Assurance Checks of new testing kits, reagents, and procedures
• Reviewed and Released the data of peers
• Wrote SOP revisions, reviewed SOP’s and validated new SOP’s (Master Control software)
• Trained new hires
• Performed general laboratory duties
o Taking temperatures, calibrating and cleaning equipment, scheduling, prepping samples for testing,
ordering supplies, assay scheduling, filing paperwork for offsite archives (Iron Mountain), troubleshoot
computer and equipment issues, and other general laboratory maintenance tasks.
Contact this candidate