JULIANA AYALA-VIQUEIRA, PhD
Westlake,OH
Summary
Quality Control Microbiology professional with experience supporting GMP cell and gene therapy operations, sterility assurance, microbiological testing, contamination control, and method implementation/validation. Performs routine daily bacterial endotoxin testing (BET/LAL) using the Endosafe PTS platform, along with sterility and bioburden testing. PhD in Public Health with expertise in microbiology, epidemiology, and biostatistics.
Overview
1
1
Certification
4
4
years of professional experience
Work History
QC-Microbiology
Abeona Therapeutics
Cleveland, Ohio
05.2025 - Current
- Conducted bioburden, endotoxin, and microbial identification testing for raw materials and in-process samples.
- Documented results in GMP systems, ensuring accurate data entry and traceable records.
- Supported aseptic processing areas by preparing media, plates, and microbial test reagents.
- Investigated out-of-specification microbiology results and compiled supporting documentation for deviations.
- Develop, update and revise microbiology Standard Operating Procedures (SOPs) to incorporate new testing methodologies.
- Technical Writing and Study Design
- Change Controls
- Collaborate with QA, manufacturing, and process development teams to troubleshoot microbiological issues.
- Coordinate the shipment of sterility testing samples to qualified third- party contract laboratories, ensuring compliance with chain-of-custody and GMP documentation requirements.
Cell Processing Technologist
University Hospitals of Cleveland
Cleveland, Ohio
03.2024 - 12.2025
- Prepared cellular therapy products for stem cell transplant patients and clinical trials.
- Supported validation and development of cell therapy processing procedures.
- Performed PCR testing including mycoplasma detection, endotoxin testing, and basic flow cytometry.
- Maintained laboratory equipment used in cell processing and ensured regulatory compliance.
- Mange the packaging and shipment of cryopreserved cellular therapy products using liquid nitrogen dry shippers (Dewars).
Microbiologist
American Health Associates Inc.
Cleveland, Ohio
06.2022 - 03.2024
- Processed clinical specimens for microbiological culture, identification, and susceptibility testing.
- Performed Gram stains and microscopic evaluations to support timely organism characterization.
- Monitored quality control procedures for media, reagents, and laboratory instrumentation.
- Documented test results accurately in laboratory information systems for provider review.
- Interpreted culture growth patterns to flag clinically significant findings and contaminants.
- Maintained compliance with CLIA, OSHA, and laboratory quality control requirements during daily workflow.
Education
PhD - Public Health — Epidemiology & Biostatistics
Walden University
Minnesota City01.2026
MS - Health Sciences — Molecular Diagnostics
George Washington University
Washington01.2019
BS - Microbiology
Inter American University of Puerto Rico
Puerto Rico01.2015
Skills
- Bacterial Endotoxin Testing (BET/LAL)
- Endosafe PTS
- Sterility Testing (USP)
- Cell Culture
- Bioburden
- GMP
- Contamination Control Strategy (CCS)
- Method Implementation & Validation Support
- Instrument Qualification
- Investigations/CAPA
- SOPs
- Microbial Identification
- Aseptic Processing
- Cell & Gene Therapy
- GMP Documentation
- TrackWise
- MALDI-TOF
Certification
- Contamination Control Certification – Biopharma Institute
- Quality Risk Management Certification – Biopharma Institute
Timeline
QC-Microbiology
Abeona Therapeutics
05.2025 - Current
Cell Processing Technologist
University Hospitals of Cleveland
03.2024 - 12.2025
Microbiologist
American Health Associates Inc.
06.2022 - 03.2024
BS - Microbiology
Inter American University of Puerto Rico
MS - Health Sciences — Molecular Diagnostics
George Washington University
PhD - Public Health — Epidemiology & Biostatistics
Walden University