Dilara K.
Manufacturing - Viral Vector & Cell Therapy at Lonza | PMP & Six Sigma Black Belt | GMP Manufacturing & Molecular Diagnostics Expert
- Role
- Validation Specialist at Marinabiolab
- Location
- Houston, TX, US
- LinkedIn followers
- 500 followers
About Dilara K.
Biotech professional with hands-on experience in viral vector manufacturing, GMP…
Experience
Validation Specialist
Jul 2024 — Present · US
Provide freelance validation and compliance support to CLIA/CAP/API. Accredited laboratories across the U.S. Specialize in molecular diagnostics for infectious disease panels, including UTI, wound, nail, STI, BV, respiratory, and antibiotic resistance testing. Ensure GLP/GMP alignment through full-cycle RT-PCR kit validations and QA-focused documentation. Conduct complete RT-PCR assay validations, including precision, reproducibility, cross-reactivity, and interference testing. Identify and resolve documentation discrepancies ahead of internal and external audits. Document validation protocols and technical summaries for research-use-only (RUO) and lab-developed tests (LDTs). Train lab personnel on RT-PCR setup, troubleshooting, result analysis, and GLP best practices. Provide QA-aligned workflow training to reinforce regulatory compliance and audit readiness. Collaborate with laboratory directors to optimize assay accuracy, sensitivity, and specificity.
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