Ramya Sri Kodali

· Performed Bio-Analytical testing such as Flow cytometry, NC-200 cell count/cell viability, DNA isolation, (LVID) Viral Vector identification, ELISA (Potency), qPCR, sub-culturing cell lines/cell passaging, and sterility.

· Maintained controls and reference standards to support testing and manage cell lines and cell banks.

· Reviewed and approved data generated by other team members.

· Performed method qualification and optimization of methods according to appropriate protocols.

· Assisted with authoring validation documentation, investigations of complexity, and investigations to understand the root cause.

· Conducted laboratory investigations and generated reports in response to invalid assays, deviations, and OOS/OOE.

· Participated in deviation investigation/CAPA implementation in a timely manner.

· Evaluated compendial updates against internal methods.

· Served as Quality Control representative on cross-functional teams.

· Utilized a comprehensive understanding of laboratory procedures, protocols, and quality control standards to provide comprehensive training to new staff members.

· Utilized LabWare LIMS and other QC data systems.

· Utilized appropriate GMP/GLP quality systems (eSOPs, Subway, etc.).

• Executed routine assays, including Membrane filtration, MPN tests and
  Plate counts to ensure accurate and reliable microbiological analysis.
• Conducted water and environmental samples for analysis, including filtration, dilution, and media preparation
• Engaged with environmental monitoring programs, identifying colonies
  on media plates.