Amanda Aurigemma Email & Phone Number

Golden, Co, Us

• Developed new analysis pipelines for NGS assays for various types of sequencing analysis• Developed internal genomic analysis tools for the Specialty Genomics Bioinformatics team• Performed data analysis prepared concise presentations of results in support of assay validation• Validated new analysis methodologies, including software lifecycle (SLC) activities• Wrote and executed SOPs, software test cases, validation, and analysis reports

Boulder, Colorado, United States

• Programmed and implemented an app for retrieving sample data from AWS, performing data analysis, and generating an FDA-compliant report to efficiently process hundreds of sequencing samples (python, AWS, json)• Assisted with the integration of existing systems to develop a streamlined data analysis process using lambda functions (python, AWS, SQL, json, fastQ, R) • Translated and optimized existing R scripts to python to support company standardization and increase efficiency• Developed processes to support manufacturing and quality control of IVD and RUO oncology product lines• Designed and directed laboratory studies to determine tolerance limits for manufacturing product (library prep, qPCR, NGS)• Developed and led technical trainings introducing team members to AWS, Excel VBA, R, python, and command line usage• Supported the quality control testing lab by helping to drive continuous improvement initiatives• Provided technical and scientific direction to oncology teams• Authored/reviewed and defined process improvements within the manufacturing process using Controlled Changes and ECOs. Updated related documentation such as SOPs, business process documents, and training materials to support continuous improvement activities• Investigated and identified product non-conformances

Boulder, Colorado, United States

• Worked closely with the Technical Transfer team to facilitate the design transfer of product between stages of development and drive continuous improvement initiatives • Programmed and implemented applications for internal report generation for use by QC technicians (VBA, python, AWS, fastQ)• Performed GMP-compliant DNA/RNA preparation and sequencing (qPCR, NGS)• Performed gap analyses for product undergoing FDA approval

• Programmed and implemented a third party application for the technical writing team (HTML, CSS, JS, json) to communicate with Smartsheet's API• Researched international regulatory standards for in vitro diagnostic medical devices; created documents summarizing major tenets and created a regulatory library to track standard updates and allow for users to pull out all guidelines related to a topic• Wrote test cases for non-product software validation efforts• Performed preliminary gap analysis for stability studies• Assisted with Tech Transfer activities for new products• Drafted technical reports and assisted the technical writing team with small document changes

Boulder, Colorado, United States

Golden, Co

• Designed and taught original STEM curricula to elementary through high school girls. Topics include chemistry/biochemistry, physics, materials science, electrical engineering, environmental engineering, and biomedical engineering• Managed a classroom of ~30 students• Trained other instructors to teach lessons• Participated in various STEM outreach efforts (judging science fairs, facilitating robotics competitions, classroom demonstrations, etc.)

Golden, Colorado

• Assisted in leading an after-school program for elementary through high school girls• Facilitated drop-off/pick-up and lead activities• Assisted instructors in a classroom environment• Participated in various STEM outreach efforts (judging science fairs, facilitating robotics competitions, classroom demonstrations, etc.)

Aurora, Colorado

• Oversaw laboratory duties to include microbiological testing of finished product and environmental monitoring• Oversaw performance of internal audits of plant sanitation, GMP’s and machine operation functions and reports results to QA Manager• Ensured that all quality systems are being adhered to and maintained at all times• Responsible for performing root cause/corrective action investigations for non-conformances• Strong interpersonal skills to effectively communicate and work with all levels of the organization• Experience in food processing environment• Familiarity with lab safety and handling of hazardous materials• Understanding of microbiology, chemistry and sanitation• Calibrated laboratory and production line equipment for accurate results• Collected in-process and finished product samples• Performed aseptic testing for microbial contamination• Followed protocols for documenting testing results• Recognized deficiencies and initiate proper follow-up• Identified and isolated product that did not meet standards• Performed in process calibrations and rebuild/replacement of water quality monitoring system ozone, pH, TDS, chlorine and turbidity probes

Tulsa, Oklahoma

• Performed various administrative tasks for the President of the Business College• Organized and present information using Microsoft Word, Excel, and Powerpoint• Communicated effectively with all levels of administration