Paulina Onofre

Research and Development Senior Reseach Assoicate @Quantimetrix

Redondo Beach, CA, US

Developed and/or optimized three HPLC methods for Vitamin D concentration (D2 and D3) in serum (including revising method validation protocol, control manufacturing process validation, and the control design protocol), hemoglobin purity in raw material, and HbA1c concentrations in human blood samples. • Reformulated the current urine dipstick control to deliver an extended shelf-life. Completely reformatted the current urine dipstick control into a new product to include point of care test (POCT) urine dipstick control in a single use non-urine matrix with extended shelf-life. Lastly, reformulated the current urine dipstick control to meet specific specifications for an original equipment manufacturer (OEM) product.• Collaborated with Siemens healthcare to investigate possible components in Level 1 Urine Dipstick Control that would cause a positive on their hCG cassettes. • Wrote several study reports to document ongoing stability studies to improve current products.• Assisted with an investigation for an HbA1c OEM product that did not pass formulation and/or stability testing. Oversaw the formulation process for five consecutive lot builds and conducted extension testing to improve the process.• Supported in updating current product Device History Files (DHF). Modified several user needs (UN), design input (DI), design and development plan (DIDP), and design failure mode effects analysis (DFMEA) documents.