Qc Scientist
CurrentAs QC scientist, I am directly involved in the continuous improvement of analytical procedure. Revises, and finalizes standard operating procedures (SOP), manage the lifecycle of each procedure by monitoring performance characteristics. As part of continuous improvement in QC lab, I design and analyze equivalency studies for new instruments. I also provide support as SME in various CAPA, change control and Out-of-Specification (OOS) investigations in writing of hypothesis and supplemental hypothesis testing. I review and sign pDNA, mRNA, protein, LNP Drug Product, and RNP Drug Product specifications, ensuring validation and regulatory compliance while responding to client queries based on relevant regulatory documents and ensuring I also serve as a Subject Matter Expert (SME) to support customer quality testing concerns and work to develop a strong partnership with our clients to ensure mutual success. Additionally, I play an active role in reviewing and approving method validation documents as SME and support policy deployment and Quality Events (QEs).
