Barbara Fitzgerald Email & Phone Number

Lake Zurich, Illinois, Us

• Participated in the qualification process of new equipment at a Pharmaceutical I&D facility, including, initiating qualification projects, routing documentation, creating change controls, reviewing documentation and overseeing Validation consultants as the on-site project manager• Worked daily with Metrology, Scientists, System Administration/IT and Quality Assurance department• Conducted 36 month equipment reviews for all qualified equipment at the facility• Oversaw vendor commissioning for newly obtained equipment• Created and executed engineering change controls for equipment, including, qualification, decommissioning and modifications• Responsible for documenting deviations and creating mitigation plans as necessary• Project Lead for the qualification of Waters Empower 3 which collects, manages, and reports chromatography test results• Participated in a data integrity initiative for the scrutiny of all computerized equipment for adherence to FDA data integrity guidelines, including 21 CFR Part 11 requirements

Bad Homburg, Hessen, De

• Generated and executed protocol studies for the qualification/requalification of Pharmaceutical Manufacturing equipment, including lyophilizers, terminal sterilizers, component sterilizers, ovens, wash stations and environmental chambers• Worked among various departments to swiftly execute, close out and approve protocol studies to minimize disruption of production lines• Worked closely with Quality Assurance to ensure compliance was maintained at all times• Created and executed engineering change controls for equipment• Responsible for documenting deviations and creating mitigation plans as necessary• Executed air flow studies for ISO Class 5 areas• Updated standard operating procedures for facility and routed for approvals• Trained new hires for Validation department• Updated Validation Master Plan monthly to keep requalification schedule current

• Assisted with summer shut down activities for Pharmaceutical Manufacturing facility• Created and executed change controls for the Engineering department• Executed air flow studies for newly installed RABS system on filling line for Validation department• Updated standard operating procedures for facility and routed for approvals

•Liaison between Engineering and Manufacturing to transfer product knowledge from Conceptual design stage to manufacturing environment•Wrote and executed software validation for Scanning Electron Microscope based quality control inspection systems •Evaluated manufacturing processes for clarity and uniformity •Worked with managers and technicians to simplify procedures •Responsible for incoming and production quality inspections of piezoelectric stages and nanopositioning systems •Worked closely with the stage manufacturer to streamline the incoming inspection process •Wrote troubleshooting guide for operators •Developed and maintained record system•Validated and debugged manufacturing database for process control•Assisted with internal Quality Compliance Audits•Maintained training records for the Manufacturing group •Trained employees on operating procedures•Created and Maintained Bills of Material for Engineering Control Orders within MRP System•Installed and qualified software on Nanofabrication systems for use in nano scale lithography, •Monitored modifications, upgrades and troubleshooting

•Developed an automated Scanning Electron Microscope inspection system to perform quality control and authentication of micron and nano scale features for NanoEncryption technology for pharmaceuticals•Performed quality control inspections on micron and nano scale MEMS production raw materials, intermediates and finished products for NanoEncryption technology•Maintained Scanning Electron Microscope system •Worked with R&D and Engineering to get products ready for full scale production•Wrote formal work instructions and operating procedures for production processes•Handled monthly lab safety inspections for GLP and BSL-2 laboratories

Northbrook, Il, Us

•Developed molecular diagnostic assays for gene detection for Hypercoagulation, Cystic Fibrosis and Warfarin sensitivity•Successfully completed clinical trials and FDA submission for Hypercoagulation and Warfarin assays•Designed, executed, troubleshot and optimized experiments•Wrote test plans and test reports•Assisted with training new employees•Worked under strict GLP environment•DNA isolation from whole blood using manual and automated methods; DNA quantitation•Data analysis and data presentation

Abbott Park, Illinois, Us

•Manufacturing of biological reagents used for screening blood transfusions for HIV, HTLV and Hepatitis.•Performed bioconjugate techniques to produce product •Experience in preparative and analytical HPLC, size exclusion and affinity chromatography for antibody/antigen purification•Designed, performed and analyzed protocols as a subject matter expert for assay troubleshooting and large scale investigations for the FDA•Trained in federal compliance regulations•Experience in cGMP, CAPA, documentation, and operating procedures•Published reports on scientific processes and procedures for quality system documentation•Improved laboratory safety and efficiency as member of Good Manufacturing Procedures and Safety Team•Improved documentation and reduced technician error as member of Process Improvement Team•Directed new employee training in manufacturing procedures and bioconjugate techniques with an emphasis on accurate and complete documentation of activities and industry compliance•Served as a mentor for new employees by scheduling training times and activities to optimize training content