Gervais-Roch Nouanounou
Fuquay Varina,NC
Summary
Dynamic Senior Microbiologist with expertise in microbial identification and a strong commitment to mentoring. At Guerbet, I optimized testing protocols and implemented quality control measures, significantly enhancing product development accuracy. Proficient in biochemical analysis, I leverage data-driven insights to inform strategic decisions and drive team success.
Overview
16
16
years of professional experience
Work History
Senior Microbiologist
Guerbet
06.2017 - Current
- Performed Sterility testing of finish goods, stability samples using the isolator.
- Performed the liquid particulate matter testing of finish products using the HIAC 9703 equipment.
- Performed Bioburden of WFI samples and finish products.
- Performed Endotoxin testing of WFI and finish products by Gel Clot and KTA Methods.
- Performed Environmental Monitoring for the classified areas (ISO).
- Collected the compressed gas and clean steam.
- Performed raw materials, components, process and cleaning validation testing.
- Performed growth promotion, gram stain and reviewed Lab generated data.
- Supported GMP Manufacturing by performing. microbiological release and in-process testing.
- Mentored junior microbiologists, enhancing team skills and knowledge in microbial analysis techniques.
- Identified root causes of contamination incidents, implementing corrective actions to prevent future occurrences.
- Designed and executed successful validation studies for new testing methods, ensuring regulatory compliance.
- Established rigorous quality control measures to maintain accuracy and reliability of test results.
QC Microbiologist Analyst
FUJIFILM Diosynth Biotechnologies
04.2016 - 04.2027
- Conducted microbiological testing to ensure compliance with quality standards.
- Developed and validated microbiological methods for product testing.
- Led investigations on deviations and implemented corrective actions to improve processes.
- Reviewed and approved documentation related to microbiological testing protocols and results.
- Monitored environmental controls, ensuring adherence to regulatory guidelines in production areas.
- Monitored environmental monitoring programs to maintain a controlled manufacturing environment.
- Reduced contamination risks by maintaining a clean and organized laboratory environment.
- Performed Environmental Monitoring, Bioburden, Endotoxin, Clean steam, compressed gas testing, Autoclave run, Data entry into LIMS system.
- Review data for compliance with specifications and GMP regulations
Biological Quality Control Analyst
Hospira, A Pfizer
08.2015 - 04.2016
- Performed Environmental Monitoring, Bioburden, Endotoxin, Clean steam, compressed gas testing,
- Performed raw materials, components, process and cleaning validation testing.
- Performed Sterility testing of finish goods, stability samples using the isolator.
- · Performed viable and non-viable particulate testing in aseptic areas using MetOne, SAS.
- Performed Environmental Monitoring for the classified areas (ISO).
- Collected and analyzed data to measure effectiveness of quality control processes.
- Reported problems and concerns to management.
- Performed routine maintenance and calibration on testing equipment.
Quality Assurance Analyst
BioMerieux
05.2014 - 07.2015
- Developed and executed test plans to ensure product quality and reliability.
- Collaborated with cross-functional teams to identify and resolve software defects.
- Established testing frameworks to enhance efficiency of quality assurance processes.
- Led root cause analysis sessions to identify issues and implement corrective actions.
- Reduced defect rates through meticulous attention to detail during code reviews, working closely with developers to address any identified issues quickly.
- Supported company in maintaining work environment focused on quality, communication, collaboration, integration, and teamwork.
- Ensured customer satisfaction by verifying that products met specifications and functioned as intended before release.
Microbiologist Associate
Merck
07.2011 - 11.2013
- Performed bioburden testing of WFI (TOC, Endotoxin, TC or Total Count, Clean Steam, and purified water).
- Performed viable and non-viable particulate testing in aseptic areas using MetOne, SAS.
- Scheduled the environmental monitoring testing activities into grade ISO5 and 7 areas.
- Ensured safety around manufacturing areas by following the GMP.
- Participated in internal audits before and after shutdown events to ensure active back up of the production.
- Performed departmental gowning training of new employees, as required, by demonstrating work procedures and familiarizing new employees with various testing areas around test sites.
- Conducted microbial assays to ensure compliance.
- Developed and validated microbiological testing protocols for product safety.
- Analyzed data trends to identify potential contamination sources in production processes.
- Led cross-functional teams in root cause analysis of microbial failures, implementing corrective actions.
- Mentored junior microbiologists on laboratory techniques and quality assurance measures.
- Increased accuracy of test results through meticulous attention to detail during data analysis and interpretation.
Education
Associate of Science - Pharmaceutical Sciences
Wake Technical Community College
Raleigh, NC06-2002
Bachelor of Science - Biochemistry
Marien Ngouabi University
Congo (Africa)07-1992
Skills
- Biochemical analysis
- Biochemical analysis
- Biochemical analysis
- Biochemical analysis
Languages
French
Full Professional
Timeline
Senior Microbiologist
Guerbet
06.2017 - Current
QC Microbiologist Analyst
FUJIFILM Diosynth Biotechnologies
04.2016 - 04.2027
Biological Quality Control Analyst
Hospira, A Pfizer
08.2015 - 04.2016
Quality Assurance Analyst
BioMerieux
05.2014 - 07.2015
Microbiologist Associate
Merck
07.2011 - 11.2013
Associate of Science - Pharmaceutical Sciences
Wake Technical Community College
Bachelor of Science - Biochemistry
Marien Ngouabi University