Stephanie Bravante

A laboratory professional with extensive knowledge and skills in all aspects of laboratory testing and biotech operations. Well-versed in IVD settting, OSHA, GMP, GDP, and FDA guidelines. A quality-oriented team player with a focus on accuracy and efficiency, bringing over 5 years of industry experience.

Assay Verification & Validation II in Clinical & Regulation - Genalyte - San Diego

(2023-06 - 2026-06)

• Oversee a team responsible for conducting testing, problem-solving, troubleshooting, and experimentation in compliance with Verification and Validation standards.
• Testing and monitoring using instrument called Merlin and Maverick
• Analyze data for the improvement of assays and processes.
• Planning, study design, and experimental layout to ensure compliance with FDA approval criteria.
• Reviewed Listing Validation Specification documents to ensure validation criteria and traceability are met.
• Prepared diluent mock plasma and TCA, as well as dialysis plasma for study purposes.
• Prepared samples for studies, including contrivances, washing red blood cells, and isolation procedures.
• Responsible for the training of new hires and cross-training of staff.
• Accountable for the procurement of supplies and maintenance of inventory records.
• Cross-training in quality assurance data entry and providing minor support for software and hardware engineering.

Process Development Chemistry/FC Associate Chemistry II (Polymer Team) - Singular Genomics - San Diego

(2022-06 - 2023-05)

• Support with raw materials in IVD standards.
• Developed and optimized polymer processes, conducting experiments to enhance product quality and efficiency.
• Collaborated with cross-functional teams to troubleshoot and resolve production issues related to G4X instrument.
• Analyzed data to inform decision-making and contributed to the documentation of standard operating procedures for polymer synthesis.

Clinical Laboratory Technologist - Helix opco LLC

(2021-01 - 2022-05)

• Performed diagnostic tests and analyses on biological samples, ensuring accuracy and quality control using laboratory equipment.
• Operated and maintained laboratory equipment, interpreted results, and collaborated with healthcare professionals to deliver timely and precise patient information.
• Adhered to safety protocols and regulatory standards consistently.
• Responsible for ensuring that the raw materials pass through the quality control procedure.

Associate Scientist (Research & Development) - Quidel

(2021-03 - 2021-08)

• Conducted experiments and analyzed data to support R&D projects, contributing to product development and optimization.
• Collaborated with cross-functional teams to design and implement protocols, ensuring compliance with industry standards.
• Prepared technical reports and presentations to communicate findings and recommendations effectively.

Lead ALT/Clinical Laboratory Technologist CLT - Helix opco LLC

(2020-08 - 2021-03)

• Led a team of clinical laboratory technologists in performing complex analyses and ensuring accurate test results.
• Oversaw the development and implementation of laboratory procedures, maintained compliance with regulatory standards, and provided training to staff.
• Collaborated with healthcare professionals to support patient care and improve laboratory efficiency.
• Conducts testing, inspection, and evaluation of products and materials to ensure compliance with stringent company safety, performance, and design standards.

Formulation Associate (Formulation Team) - Biolegend

(2019-01 - 2020-01)

• Conduct manual pipetting and operate automated systems for formulating and dispensing antibodies, including biotin and recombinant variants.
• Proficient in the use of Biological Safety Cabinets (BSC) and fume hoods.
• Experienced in working within a Good Manufacturing Practice (GMP) environment.
• Operated industrial mixers for the compounding and blending of chemicals.
• Reduced product defects by implementing quality assurance protocols.
• Calibrated laboratory equipment.

Laboratory Technician /Phlebotomy - Sharp Hospital

(2013-05 - 2013-08)

• Performed venipunctures and capillary draws for blood collection, ensuring patient comfort and safety.
• Conducted laboratory tests, maintained equipment, and adhered to quality control protocols.
• Collaborated with healthcare professionals to ensure accurate and timely results, while managing patient records and data entry efficiently.

Laboratory Technician/Phlebotomy - Balboa Naval Hospital

(2011-09 - 2013-05)

• Performed phlebotomy procedures, collected and processed patient samples, and maintained accurate records of specimen handling.
• Conducted laboratory tests, ensured compliance with safety protocols, and assisted in maintaining laboratory equipment.
• Provided exceptional patient care and support during sample collection.

Laboratory Assistant - Scripps Mercy Hospital

(2011-06 - 2011-09)

• Assisted with laboratory experiments by preparing samples, maintaining equipment, and ensuring adherence to safety protocols.
• Conducted routine tests and recorded data with precision, collaborated with team members on research projects, and maintained an organized laboratory environment to support efficient workflow and accurate results.

CPT/Qualified Mental Health Associate - Alvarado Parkway Institute

(2009-08 - 2011-06)

• Provided comprehensive support to clients by implementing treatment plans, facilitating therapeutic activities, and conducting assessments.
• Collaborated with multidisciplinary teams to improve client outcomes, ensuring a safe and supportive environment.
• Monitored progress and maintained accurate documentation of client interactions and treatment updates. Also, draw routine patient blood.

Medical Specialist - California College San Diego (2008-06 - 2010-03)

Bachelor Degree - Clinical Laboratory Science - National University, San Diego (2013-06 - 2018-02)