Proficient in cell-based assays (PFU and FFU titer testing), mammalian cell culturing, potency and impurity ELISAs, and qPCR.Carried out batch record reviews when other departments were short-staffed and deadlines for batch releases were approaching.Executed qualifications for 2 impurity ELISAs, 1 PFU titer assay, and 1 potency ELISA and performed report writing.Opened quality records to document lab events and deviations and assisted with progression of QMS records and investigations.Worked with Bioassay and QC Review departments to expand GDP knowledge and reduce the number of errors found in data packages during review.

Working onsite at Resilience.

Use STARLIMS to enter specimens into the lab, create runs, enter results, and release specimens into production. Maintain aseptic technique when inoculating specimens into liquid media. Prepare tissue samples for histotechnologists.Maintains laboratory supplies inventory by checking stock to determine inventory level; anticipating needed supplies; placing and expediting orders for supplies; verifying receipt of supplies.Perform ELISA analyses to determine bone morphogenetic protein (BMP) concentrations in bone matter.Sub-culture bacterial specimens from liquid and solid media for use in morphologic identification.Collaborated with R&D, QA, and Manufacturing to measure endotoxin levels in finished product and formulate methods and processing procedures to reduce endotoxin levels and bioburden.Developed new method for processing bioburden samples to reduce cross-contamination and decrease bioburden levels.Organized and sent out donor blood samples for covid-19 antibody research studies.

Completed training 33% faster than the average tech. Uses chemical treatments to clean and disinfect equipment.Operates autoclaves and Sterrad systems to sterilize equipment using steam or hydrogen peroxide. Distributes equipment to tissue processors to ensure production goals can be achieved. Dawns appropriate PPE and uses aseptic techniques when handling hazardous materials or entering cleanrooms to prevent exposure and cross-contamination. Follow SOP to dispose of hazardous materials in a safe manner. Prepare biological indicators and RODAC samples for testing. Accurately completes paperwork and data entry in accordance with Good Documentation Practices.