Devi Pogula
Austin,TX
Summary
Ph.D. Biochemist and quality professional with over a decade of experience in microbiology, biotechnology, and cGMP-regulated environments. Demonstrated expertise in aseptic technique, environmental monitoring, and microbial testing. Maintained strict documentation practices, supported audit preparedness, and collaborated across teams. Currently contributing to microbiology quality control and compliance.
Overview
21
21
years of professional experience
Work History
Documentation & QC Associate
Set Labs LLC
San Diego, CA
02.2021 - Current
- Executed microbiological documentation and reviewed batch release records and CoAs
- Drafted and revised GMP-compliant SOPs for microbiology and sterility testing
- Collaborated with QA to support investigations, CAPAs, and audit responses
- Reviewed environmental monitoring records and ensured timely data entry into LIMS
Quality Control Scientist
Uni-Sankyo Pharmaceuticals
Hyderabad, India
01.2018 - 01.2021
- Performed bioburden and endotoxin testing of raw materials and finished products
- Conducted EM and water testing in aseptic areas and reviewed trends quarterly
- Developed microbial sampling plans for validation and routine production
- Ensured compliance with GDP and cGMP in batch records and documentation
Research Scientist
Portland State University
Portland, OR
02.2007 - 06.2015
- Carried out microbial growth studies under simulated GMP cleanroom conditions
- Used SEM to study cyanobacteria mineralization and performed PCR validation
- Maintained culture sterility and trained interns in aseptic lab techniques
- Authored technical reports and presented microbial findings at conferences
Postdoctoral Fellow - Microbial Biotech
University of Delaware
Newark, DE
04.2004 - 01.2007
- Engineered protein expression systems and ensured low endotoxin contamination
- Used HPLC and SDS-PAGE to analyze microbial proteins for medical applications
- Implemented controlled growth conditions for microbial fermentation studies
- Wrote SOPs and participated in quality assurance review cycles
Education
Ph.D. - Biochemistry
Osmania University
Biowork Certificate -
Wake Technical Community College
SOP & cGMP Certification -
Durham Technical Community College
Medical Devices QA Training -
Oregon Bioscience Association
BIT 125 - Quality Systems
Portland Community College
Skills
- Aseptic technique
- Microbial culturing
- Gram staining
- Endotoxin testing
- Bioburden
- EM
- Sterility testing
- Media prep
- CGMP
- GDP
- SOPs
- CAPA
- Deviations
- Audit support
- SDS-PAGE
- PCR
- HPLC
- Western blot
- DNA isolation
- SEM
- LIMS
- Salesforce (Admin Certified)
- Microsoft Office
Timeline
Documentation & QC Associate
Set Labs LLC
02.2021 - Current
Quality Control Scientist
Uni-Sankyo Pharmaceuticals
01.2018 - 01.2021
Research Scientist
Portland State University
02.2007 - 06.2015
Postdoctoral Fellow - Microbial Biotech
University of Delaware
04.2004 - 01.2007
Ph.D. - Biochemistry
Osmania University
Biowork Certificate -
Wake Technical Community College
SOP & cGMP Certification -
Durham Technical Community College
Medical Devices QA Training -
Oregon Bioscience Association
BIT 125 - Quality Systems
Portland Community College
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