Experience

NextCure, Inc.

• United States
• Biotechnology Research
• 1 - 100 Employee

• Associate Director of Quality Control

  • May 2022 - Present

• Senior Manager Quality Control

  • Nov 2021 - May 2022

• Manager Quality Control

  • Mar 2021 - Nov 2021

• Specialist

  • Mar 2020 - Mar 2021

  - Created improvements on the data management for routine environmental monitoring data, data from the building management system, and WFI system - Authored Routine Environmental Trend Reports - Oversaw contract testing laboratory for microbial assays - Project management oversight of disinfectant efficacy study and hold time studies performed by outside testing laboratory - Authored validation documentation for IQ/OQ/PQ of Quality Control equipment - Ensured annual department… Show more - Created improvements on the data management for routine environmental monitoring data, data from the building management system, and WFI system - Authored Routine Environmental Trend Reports - Oversaw contract testing laboratory for microbial assays - Project management oversight of disinfectant efficacy study and hold time studies performed by outside testing laboratory - Authored validation documentation for IQ/OQ/PQ of Quality Control equipment - Ensured annual department budget was forecasted and maintained by examining all consumables, outside testing laboratory fees, shipping costs, major studies and new equipment pricing was included



Catalent Pharma Solutions

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QC Analyst

  • Aug 2019 - Mar 2020



Novavax

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Quality Control Analyst

  • Aug 2018 - Aug 2019

  - Provided support to vaccine development by performing microbiological assay including LAL testing by the kinetic chromogenic method, bioburden, and biological indicator testing. - Assisted in investigations relating to microbiological assay results with Quality Assurance and Manufacturing. - Executed assay validation for new sample types for Bioburden and LAL testing. - Provided subject matter expertise in areas of microbiological knowledge including contamination investigation… Show more - Provided support to vaccine development by performing microbiological assay including LAL testing by the kinetic chromogenic method, bioburden, and biological indicator testing. - Assisted in investigations relating to microbiological assay results with Quality Assurance and Manufacturing. - Executed assay validation for new sample types for Bioburden and LAL testing. - Provided subject matter expertise in areas of microbiological knowledge including contamination investigation, invalid assay trouble shooting, and validation procedures. - Conducted Quality Control release of media and microorganisms. - Trained junior analysts in SOPs and assay execution. - Revised SOPs, test methods and forms to improve Right First Time. - Authored CAPAs, deviations, and Change Controls when necessary. - Utilized MODA- FDC, Share Point, and Electronic Data Management System. - Maintained effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing, Validations, and Facilities. - Ensured that laboratory equipment was calibrated, standardized, and validated as appropriate. - Assisted with interviewing and hiring new team members and provided training, guidance, and recommendations, to new and existing team members. Show less - Provided support to vaccine development by performing microbiological assay including LAL testing by the kinetic chromogenic method, bioburden, and biological indicator testing. - Assisted in investigations relating to microbiological assay results with Quality Assurance and Manufacturing. - Executed assay validation for new sample types for Bioburden and LAL testing. - Provided subject matter expertise in areas of microbiological knowledge including contamination investigation… Show more - Provided support to vaccine development by performing microbiological assay including LAL testing by the kinetic chromogenic method, bioburden, and biological indicator testing. - Assisted in investigations relating to microbiological assay results with Quality Assurance and Manufacturing. - Executed assay validation for new sample types for Bioburden and LAL testing. - Provided subject matter expertise in areas of microbiological knowledge including contamination investigation, invalid assay trouble shooting, and validation procedures. - Conducted Quality Control release of media and microorganisms. - Trained junior analysts in SOPs and assay execution. - Revised SOPs, test methods and forms to improve Right First Time. - Authored CAPAs, deviations, and Change Controls when necessary. - Utilized MODA- FDC, Share Point, and Electronic Data Management System. - Maintained effective communication with other relevant groups, including but not limited to Quality Assurance, Manufacturing, Validations, and Facilities. - Ensured that laboratory equipment was calibrated, standardized, and validated as appropriate. - Assisted with interviewing and hiring new team members and provided training, guidance, and recommendations, to new and existing team members. Show less



Microworks, Inc

• United States
• Biotechnology Research
• 1 - 100 Employee

• Laboratory Technician

  • Jun 2016 - Jul 2018

  • Responsible for daily, weekly and monthly cleaning of the laboratory, incubators and refrigerators. • Responsible for operation of Getinge sterilizer, including monthly leak test and Bowie Dick test. • Responsible for set-up of validation projects including preparation of test plates and experimental set up.

• Microbiologist

  • Jun 2016 - Jul 2018

  • Responsible for sterility testing of injectable finished products and medical devices • Responsible for cleaning and environmental monitoring of a sterility suite. • Responsible for endotoxin testing of injectable finished products using Kinetic Turbidimetric Assay. • Responsible for performing microbiological testing including analysis of water and bioburden samples. • TOC and conductivity analysis of water samples. • Responsible for performing USP <61> and <62>… Show more • Responsible for sterility testing of injectable finished products and medical devices • Responsible for cleaning and environmental monitoring of a sterility suite. • Responsible for endotoxin testing of injectable finished products using Kinetic Turbidimetric Assay. • Responsible for performing microbiological testing including analysis of water and bioburden samples. • TOC and conductivity analysis of water samples. • Responsible for performing USP <61> and <62> release testing of pharmaceutical products. • Performs environmental monitoring at client facilities including analysis for particle counts using a Climet particle monitoring system and viable airborne monitoring using a SAS air sampler. • Performs identifications of microorganisms using the Vitek V2C. • Prepares reports for clients and assists in writing and revising SOPs