Violetta Ilyassova
Nutley,NJ
Summary
Accomplished Research Scientist, Lab Technician, and Quality Control Associate with hands-on experience in GMP-regulated environments and advanced diagnostic laboratories. Proven track record at INVAC Poland and currently supporting FDA-approved cell and gene therapy testing at Minaris Regenerative Medicine. Adept in PCR techniques, in-process and release testing, and flow cytometry, with a strong focus on regulatory compliance, equipment validation, and data integrity. Recognized for interdisciplinary collaboration, meticulous documentation, and a commitment to product quality and patient safety.
Overview
3
3
years of professional experience
Work History
Quality Control Associate I
Minaris Advanced Therapies
12.2024 - Current
- Perform in-process, release, stability, and checkpoint testing on FDA-approved cellular and gene therapy products using methods such as cell count, viability, endotoxin, flow cytometry, CBC, and ELISA
- Execute testing per SOPs under cGMP/GDP guidelines to ensure product quality, safety, and regulatory compliance
- Maintain, calibrate, and troubleshoot lab equipment; support equipment qualification, validation, and start-up/shutdown routines
- Investigate and document OOS/OOT results; initiate and manage deviations, CAPAs, and Change Controls
- Serve as QC project co-lead, liaising with clients and leading meetings with QC management support
- Support audits as QC SME and ensure lab remains inspection-ready
- Crosstrain on multiple client methods; assist in training and onboarding new technicians
- Manage real-time data uploads and documentation via internal systems and client SharePoint; support timely batch record and CoA completion
- Maintain inventory, prepare reagents/media, and coordinate external sample shipments
- Ensure proper documentation, training record maintenance, and compliance with retention policies
- Collaborate effectively across teams, departments, and with external client
Lab Technologist
INVAC Poland
09.2023 - 05.2024
- Prepared and examined specimens using variety of instruments, histologic, microbiology and molecular diagnostic techniques (real-time PCR QuantStudio, ELISA, culturing ans isolating)
- Prepared samples for analysis by performing complex sample preparation tasks (DNA and RNA isolation)
- Recorded and analyzed data to produce reports of results.
- Maintained confidentiality of all patient information to conform to HIPAA, internal, and other regulatory standards.
- Troubleshot technical issues with laboratory equipment, minimizing downtime and ensuring continuity of services.
- Collaborated with interdisciplinary teams for accurate diagnosis, contributing to improved patient outcomes.
- Troubleshot equipment malfunctions, ensuring minimal downtime and maintaining optimal functionality.
Research Scientist
Catholic University in Lublin
01.2022 - 06.2023
- Analyzed different samples using fluorescence spectrometer and UV-Vis spectrophotometer.
- Generated data models and performed analysis to produce reports outlining results.
- Maintained a safe working environment by enforcing strict adherence to laboratory safety guidelines.
- Completed testing projects by deadline.
Education
Master of Science - Biotechnology
Catholic University of Lublin
09-2023
Bachelor of Science - Biotechnology
Catholic University of Lublin
09-2021
Skills
- GMP environment
- Laboratory methodologies
- Data Analysis
- Documentation And Reporting
- Specimen handling
- Sterile technique
- Cell Culture Techniques
- Microbiology Techniques
- PCR Techniques
- Flow cytometry
- ELISA
- SOP development
Languages
Kazakh
Native or Bilingual
Russian
Native or Bilingual
Ukrainian
Native or Bilingual
Polish
Native or Bilingual
Timeline
Quality Control Associate I
Minaris Advanced Therapies
12.2024 - Current
Lab Technologist
INVAC Poland
09.2023 - 05.2024
Research Scientist
Catholic University in Lublin
01.2022 - 06.2023
Master of Science - Biotechnology
Catholic University of Lublin
Bachelor of Science - Biotechnology
Catholic University of Lublin
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