Denisse L. Email & Phone Number

United States

Carlsbad, California

San Marcos, Ca

· Assist in developing new immunoassay products/methods, optimize synthetic calibrators, controls, working solutions and intermediates for in-vitro diagnostic use for automated chemistry systems and POC instruments (i.e. lateral flow). · Manufacture new and existing in-house and OEM products. · Hands on knowledge of running and maintaining in-vitro diagnostic instruments, conduct performance qualification studies on new instruments, train personnel on usage, and prepare PQ/IQ/OQ reports. Continually evaluate and create work instructions, quality control records, standard operating procedures, and other documents/procedures for effectiveness. · Perform aseptic processes such as filtration, filling, microbial plating. · Collaborate with the Quality department to complete 510K submissions to the FDA. · Provide technical expertise for new incoming projects.

San Marcos, Ca

· Technical complaint lead; coordinated investigations for product complaints and led monthly meetings with multi-departmental management to discuss complaints. · Implemented standardized reporting of complaint investigations, submitted regular reports and/or input of investigation results to regulatory affairs. · Handled all internal and external customer inquiries via telephone and email. · Coordinated internal and external value assignment of products. · Compiled and analyzed value assignment data using Excel. · Produced lot specific inserts for review by Marketing and Regulatory.

Carlsbad, Ca

· Prepared and performed quality control testing from all phases of manufacturing of pharmaceuticals. · Maintained and operated analytical instrumentation. · Performed QC testing (real-time and stress) using dissolution testers, UV spectrophotometer, Thin-Layer Chromatography, and HPLC to determine the purity of the product. · Performed daily pH meter and balance calibrations, hazardous waste and chemicals disposal, as well as a variety of other laboratory tasks.

Greater San Diego Area

· Provided technical support and instruction to medical professionals and staff on a variety of point-of-care instruments such as the Cholestech LDX, Triage Meter, and INRatio devices. · Resolved customer concerns raised during installation, operation, maintenance and product application. · Troubleshoot issues with malfunctioning equipment or software applications and recommended corrective action. · Instructed on proper use of INRatio analyzer to patient self-testers. · Documented service calls and repair services using the company’s established procedures. · Tracked and managed open cases and followed up with customers in a timely manner. · Documented all field notifications responses into company database.

Vista, Ca

-Assisted with scheduling, payroll, and Human Resource needs.-Provide support to guests, applicants and fellow team members. -Screened potential hires.-Assisted with new orientations.-Price Accuracy Team/SalesFloor Team Member.

San Marcos, Ca

· Conducted research on the antibiotic activity of sediments isolated from bacteria collected on the La Jolla shore on Mycobacterium marinum. · Prepared media (agar plates & broth), cell culture, performed inoculation of bacteria on both agar and broth media, ran bioassays via aseptic technique, and tested samples via H NMR spectroscopy in order to determine its electronic structure and functional groups.

Las Vegas, Nevada Area

· Examined stationary phase mutagenesis in Bacillus subtilis, specifically the Spo0A gene and its effect on sporulation in cells when the gene is present and deactivated.· Investigated the accumulation of mutations in two chromosomal markers in cells made in various types of media.· Performed restriction digests, ligations, and bacterial transformations.· Performed stationary phase assays, PCR, DNA/RNA extractions, gel electrophoresis, cloning, UV spectrophotometer, cell culturing, microbial plating.

Vista, Ca

-Certified Health Educator, CPR certification, front desk assistant, patient check-in, answered patient calls and provided information needed, scheduled appointments.-Contacted insurance companies to inquire information about patient.-Screened patients prior to visit with physician.-Medical records filing. -Followed HIPAA regulations-Proactively outreached to the community regarding programs available by VCC. -Assisted with community class promoting a healthy lifestyle.

Master Of Science (M.S.), Biotechnology

Bachelor Of Science (B.S.), Molecular Biology

Activities and Societies: Biotech Club, Pre-Health Society, Orientation Team, STEM