RachelEmma Flood
Raheny
Summary
Seasoned Plant Microbiologist with a robust history at Pfizer, adept in Annex 1 compliance and contamination control. Excelled in leading gap analyses, enhancing microbial control, and spearheading quality risk assessments. Demonstrates exceptional problem-solving skills and a commitment to continuous improvement, underpinned by expertise in LIMS and Six Sigma methodologies.
Overview
13
13
years of professional experience
Work History
Plant Microbiologist
Pfizer
09.2021 - Current
- Supported Annex 1 implementation, conducting gap analyses to ensure compliance, including MCCS's for drug substance, and product manufacturing areas.
- Monitored and evaluated aseptic practices at the site, and conducted continuous evaluation of microbial control effectiveness.
- Coordinate metrics, investigations, protocols, reports, CAPAs, and aseptic controls; participate in site-wide investigations.
- Engaged in contamination response activities for both single-use and stainless-steel facilities.
- Liaise with Microbiological Aseptic Control Teams across the network.
- Provide SME knowledge of aseptic practices within the site cleanrooms to external customers, and regulatory inspectors.
- Perform and assess quality risk assessments. Develop strategies to mitigate microbial contamination, and develop best practices.
- Provided SME guidance for new equipment, manufacturing areas, processes, training, workshops, disinfectants, etc.
- SME for EM Program for site analysis, H.A.C.C.P. for Grade CNC - Grade A (Isolator).
QC Microbiology Analyst, EM Senior Analyst
Pfizer
09.2019 - 09.2021
- Approve, trend, and present EM data to the Environmental Compliance Forum and Environmental Review Committees, including production-related monitoring and fill-finish operations.
- Raise investigations and facilitate site requests regarding events, QARs, CAPA effectiveness, etc.
- HACCP risk assessment creation and review on a routine and preliminary basis for existing and new processes and areas.
- Liaise with other departments to coordinate and advise on EM Performance Qualification testing, area recoveries, and retesting.
- The point of contact for planned area shutdowns facilitates and organizes EM recoveries for disruptions to classified areas.
- Drive continuous improvement through process improvements and cost-saving projects.
- IMEX CI Champion, IMEX Training Champion.
- Regulatory audit support and preparedness for both EM and training perspectives, including backroom support experience and a point of contact for QC.
- Participate in Method 1s (Investigations)when required.
- Site-wide production-related EM training coordinator.
- Supervisor delegate when required
- Proficient in the use of PDOCS, LIMS, EMDA, and QTS
- Performing investigative EM walkdowns
QC Microbiology Analyst, Environmental Monitoring
Pfizer
07.2015 - 09.2019
- Sampling of site utilities, environmental monitoring including viable/non-viable testing, and LIMS.
- Full Gowning Training, Grade A/B gowning training.
- Working with grade A isolator technology in SFF, and performing EM monitoring, including end-of-fill activities.
- Developed excellent aseptic technique in isolators, cleanrooms, and BSCs.
- Monitoring and maintaining stock, inventory, and routine and production-related EM activities.
- Documentation review, approval, and archival, generating EM monthly/quarterly reports and utility reports.
- Audit preparation/readiness.
QC Microbiologist
Vistakon Ireland Limited
02.2014 - 09.2014
- Routine environmental monitoring, utility water sampling, bioburden testing of medical devices, Microbial identification tests
- Audit preparation and readiness, safety inspections.
- Introduced LIMS systems to the company, Validation of new equipment for the new lab: IQ, OQ, PQ.
Microbiology Dept, Infectious Diseases
ICON Central Labs
09.2011 - 12.2013
- Microbial identifications, Gram stain, bench tests, API, MICs, Vitek. Biological patient samples, medical device, sterility testing, water bioburden testing, media preparation, sample preparation, aseptic techniques.
- Maintaining quality reports and patient results, monitoring, and preparing inventory.
- IQ, OQ, and PQ of new lab equipment.
- Audit preparation, quality reports, and training new staff.
Education
A Risk Based Cleaning and Disinfection Program Certificate -
Steris
06.2024
Downstream Processing Certificate -
NIBRT
06.2024
Aseptic Fill Finish Operations Certificate -
NIBRT
07.2018
Graduate Certificate - Biopharmaceutical Production
UCD, NIBRT
05.2015
BSc Hons - Pharmaceutical Technology
DIT
Dublin, Dublin 105.2011
Skills
- Annex 1
- Grade A (Isolator)
- Investigations (Six Sigma)
- Contamination response
- Quality Risk Assessments
- MCCS
- Gowning
- Disinfectants
- LIMs
- MODA
- EMDA
References
References available upon request.
Timeline
Plant Microbiologist
Pfizer
09.2021 - Current
QC Microbiology Analyst, EM Senior Analyst
Pfizer
09.2019 - 09.2021
QC Microbiology Analyst, Environmental Monitoring
Pfizer
07.2015 - 09.2019
QC Microbiologist
Vistakon Ireland Limited
02.2014 - 09.2014
Microbiology Dept, Infectious Diseases
ICON Central Labs
09.2011 - 12.2013
A Risk Based Cleaning and Disinfection Program Certificate -
Steris
Downstream Processing Certificate -
NIBRT
Aseptic Fill Finish Operations Certificate -
NIBRT
Graduate Certificate - Biopharmaceutical Production
UCD, NIBRT
BSc Hons - Pharmaceutical Technology
DIT
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