Ann Bui Email & Phone Number

Richmond Hill, Ontario, Canada

North York, Ontario, Canada

Integration of the sterility assurance and contamination control programs into commercial manufacturing operations. Led a team of individuals responsible for oversight of sterility assurance shop floor activities and programs in the cP, Diphtheria and Tetanus bulk manufacturing facility including management of changes and investigations. Maintain sterility assurance and contamination control programs through the periodic revaluation of lifecycle risk assessments to ensure alignment with process changes and industry standards. Successfully qualified all aseptic manufacturing processes using single use technology and responsible for the maintenance of the periodic revalidation programs for the facility. Provide guidance and expertise for smoke studies, autoclave hold studies, container closure integrity studies and sterile hold studies.Led a cross functional committee focused on the review of environmental monitoring and clean utilities monitoring data to bring awareness to adverse trends, empower individuals to take action and drive continuous improvement initiatives. Develop strategies and processes for product changeover to reduce risk of cross contamination for a multi product manufacturing facility.

North York, Ontario, Canada

Develop all sterility assurance and contamination control programs for a new bulk manufacturing facility using risk focused QbD strategies. Design sterility assurance training programs and validation strategies for the qualification of HVAC and utility systems. Manage all contamination risks and the end to end contamination control strategy throughout the project lifecycle. Accountable for the delivery of all project milestones tied to the sterility assurance and support work streams. Act as subject matter expert for the introduction of barrier isolator technology into the manufacturing process to reduce contamination risk.Responsible for various continuous improvement projects including the streamlining and simplification of processes for release of the facility and utility systems following intrusive maintenance to reduce operational expenditures and reduce production downtime. Implementation of electronic logbooks for the documentation of cleaning and disinfection activities in the manufacturing areas as part of the digital roadmap. Led the qualification and implementation of new generation disinfectants to reduce chemical residues and contact time.

Alliston, Ontario

Project leader for sterility assurance remediation work stream that targeted quality and compliance process improvement initiatives. Operated in a cross-functional team to co-ordinate and close out laboratory investigation reports. Developed and implemented a risk-based environmental monitoring program through a real-time risk assessment. Led the qualification of environmental monitoring equipment and integrated data repository systems such as Data Analyst and LIMS to increase operational efficiency including the review of IQ/OQ/PQ protocols for execution.Supported the documentation remediation work stream in streamlining documentation practices and re-structuring of sterility assurance SOPs and integration of test method process flow maps. Change control initiator for all documentation changes to ensure ongoing compliance to applicable internal global and compendial requirements.

Alliston, Ontario

Accountable for the change control workflow process for all quality and compliance changes within the sterility assurance department. Led the sterility assurance investigations team in the timely closure of outstanding laboratory investigation reports. Co-ordinate with QC and Operations to perform thorough root cause analysis and implementation of corrective and preventative actions.Developed and led training for contamination control and microbiology best practices across the site as well as QC specific test method training. Author and review technical documents including validation protocols, out of limit investigations, non-conformance reports and trend reports. Well-versed in utilizing various risk assessment tools including FMEAs and HACCPs to assess potential impact to systems and processes. Conducted limit assessments to revise the existing environmental monitoring program to align with current industry standards including PDA, ISO and Annex 1. Responsible for ensuring audit readiness during internal and external inspections from Health Canada and the FDA.

Richmond Hill, Ontario

Provided quality oversight during isolator aseptic media fill simulations and smoke studies and broth visual inspection processes. Led the qualification of microbiologists and production operators for broth inspection and aseptic interventions on the sterile filling line. Qualified trainer for all environmental monitoring test methods including swab processing, environmental (sterile and non-sterile) monitoring and bioburden testing for cleaning validation and critical utility samples. Lead reviewer for all QC test results to ensure timely batch release in LIMS.Authored technical documents including trend reports, investigation summary reports and protocol summary reports. Accountable for initiating change controls and deviations in QMS Trackwise in response to environmental excursions and laboratory investigations. Responsible for the execution of environmental monitoring test method validations including VHP ingress studies and media recovery studies.

Richmond Hill, Ontario

Responsible for the aseptic viable and non-viable sampling of sterile and non-sterile manufacturing areas of the facility as well as routine monitoring of critical utilities including total organic carbon, conductivity, clean compressed air, clean steam, purified water and water-for-injection. Performed microbial bioburden testing of water and cleaning validation samples as per USP. Accountable for reporting and documenting accurate environmental, bioburden and biological indicator test results.Qualified to perform aseptic interventions on the Grade A sterile filling line. Responsible for ensuring the timely review of QC test results on LIMS for batch release. Perform routine microbial identification tests including gram stains and ID of environmental isolates and objectionable organisms.

Vaughan, Ontario

Manage a team of microbiology analysts across multiple shifts to ensure ongoing support to external clients. Co-ordinate all operational and testing activities within the microbiology contract laboratory. Liase with external clients to ensure timely receipt of samples and turnaround times for results. Responsible for ensuring the successful semi-annual laboratory proficiency testing from the American Proficiency Institute (API) to high standing in order to demonstrate laboratory competency.Responsible for the review of certificates of analysis and laboratory documentation prior to release of test results. Perform root causes analysis for deviations and implement corrective and preventative actions for laboratory investigations. Accountable for day-to-day operations including inventory, equipment calibration and maintenance. Perform test method validations for microbial bioburden testing of food samples and maintenance of ATCC stock and working cultures.

Vaughan, Ontario

Responsible for all QC activities from sample receipt, testing to reporting of results. Preparation of media, diluents and buffers to support microbial test methods. Perform microbial bioburden testing of environmental samples, raw materials and finished products. Conduct qualitative screening and confirmation for foodborne objectionable pathogens such as Escherichia coli, Listeria spp., and Salmonella spp. in produce and environmental samples using PCR gel electrophoresis technology.Performed growth promotion testing of media prior to use. Ensured all documentation has been recorded as per good documentation practices and perform secondary verification of test reports generated through LIMS for accuracy. Maintenance of ATTC stock and working cultures for growth promotion testing.

Vaughan, Ontario

Co-ordinate laboratory activities including sample receipt and reconciliation against sample test requisition forms. Perform routine cleaning and disinfection and environmental monitoring. Responsible for daily calibrations for lab equipment according to EPOIs. Conduct quantitative analysis using in-house methods for TAMC, TCMC, and TYMC as well as qualitative initial screening and confirmation for foodborne pathogens such as Escherichia coli, Listeria spp., and Salmonella spp. in produce and environmental samples via in-house PCR gel electrophoresis technology methods.

Honours Bachelor Of Science (Bsc), Biomedical Sciences, Psychology Minor

Activities and Societies: Science Society

Industrial Pharmaceutical Technology Certificate, Regulatory Affairs