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.
• 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

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.
• 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

• 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

• 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

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