Provide support and regulatory guidance to the CellCarta Quality Assurance department and customer base. Facilitation of QMS harmonization across all CellCarta entities. Recruitment and training of Quality Assurance personnel. Participate in business strategy meetings with company leadership, present in governance meetings and contribute to the company regulatory strategy. Execution of corporate projects, including authorship of Computerized Systems Validation (CSV) packages for newly-developed systems and FDA IDE submissions, development and deployment of new company processes and quality frameworks, quality improvement initiatives, and more.

Responsible for complete oversight of the laboratory quality management system and the management of the company Quality Assurance Department. Tasked with the building and professional development of a small team of highly effective quality assurance personnel and the construction and implementation of novel quality systems.Development of regulatory and quality frameworks supporting new technologies, testing platforms and software systems implemented in the laboratory. After the company was acquired, integration of the laboratory QMS with the other corporate entities and contribution to the development of the global corporate quality framework. This included the strategic development, validation and implementation of a new eQMS (MasterControl) and LIMS platform (StarLIMS).Regulatory consulting for customers and preparation of IDE submissions to the FDA.Enacted and led initiatives to develop an effective quality culture throughout the company, enact process improvements across all phases of company workflows, and develop data-driven procedures to inform strategic decision-making by company ownership.

Transitioned into the Quality Assurance department to fill a vacancy previously held by the previous, lone QA representative. In this role as the head of the department, I maintained and developed the existing QMS and ensured compliance with the regulations and guidelines established by the Code of Federal Regulations, OSHA, CLIA, CAP and the states of CA and NY, while leveraging my experience in operations to improve the efficacy of the auditing and quality improvement programs. In this role, I oversaw and performed GLP/GCP-based audits for over 400 preclinical and clinical trial studies, performed internal systems audits and submitted audit reports and biannual metrics reports to company management. I was also responsible for vendor qualification, document control procedures, change management, equipment and computer system qualification, quality improvement and CAPA processes, and served as company Archivist. Additionally, I was the primary coordinator and hosts for all sponsor audits and regulatory inspections.

As a Laboratory Technician, I was dually responsible for contributing to the development and/or the validation of over 200 single analyte and multiplex immunohistochemistry (IHC) and fluorescence in-situ hybridization (FISH) laboratory tests, and for performing high daily volumes of automated and manual histological and molecular laboratory tests in support of clinical trial (phase I-IV) and preclinical studies sponsored by the company’s pharmaceutical customer base. In this role, I also supported the Project Management department by tracking the progress of studies and assisting the Lead Technician in scheduling tests. This responsibility involved the monitoring of upcoming projects to plan the procurement and preparation of materials and the communication of timelines in order to ensure timely analysis and reporting of results after samples were stained.I contributed to the authorship of standard operating procedures, assisted in troubleshooting technical issues and developed improved laboratory workflows and processes. Maintenance of documentation of all laboratory activities in compliance with Good Documentation Practices and standard operating procedures was essential for this role.

As a Project Assistant in a small company setting, I was responsible for a large variety of tasks within the company. Primarily, I was responsible for the preparation of samples and materials for the completion of laboratory tests by the technical staff. This required constant coordination with the laboratory technicians, the project managers and the Study Director to ensure all scheduled tests were completed promptly in order to ensure proper time for analysis and data reporting.Additionally, I was responsible for the procurement and management of tissue samples, laboratory materials and supplies, data transcription and QC using Microsoft Excel, operation and preventive maintenance of laboratory equipment, environmental monitoring and QC procedures.Collaboration, organization and efficient time management was necessary to ensure daily projects were completed and to ensure deliverables are provided within the established study deadlines. This required constant coordination with the study Project Manager, the Study Director and management. During this time, I developed an understanding of GLP, GCP and CLIA/CAP regulations and guidelines, supported the development and validation of over 40 laboratory tests, and developed the foundational laboratory skills I would eventually use as a laboratory technician for the company.

Develop individualized training and development plans for 50+ student athletes, administrative oversight of the program, planning and maintenance of program budget, fundraising, meet management. Co-Race Director: City of Lake Forest Charger 5K (800+ participants), Orange County Cross Country Championships (3400+ participants)

Gradual induction from an observational role to a full-time teacher responsible for the co-planning of curriculum and the instruction of nearly one-hundred students across three class periods as part of the CSU Fullerton Single Subject Teacher Credential program.Focus is on the development of instructional content based upon CA NGSS and ELD standards while providing opportunities for students to develop and grow science and engineering practices and skills, content knowledge of disciplinary core ideas and cross-cutting concepts and content-based literacy using research-based practices while facilitating socio-emotional growth and the development of successful academic habits for continued academic success.

Mentorship and education of over 300 high school athletes, utilizing both knowledge in physiology obtained from college education and knowledge in training obtained from the experience of training at the collegiate level.- Supervised a 5-day camping trip in Santa Barbara along with three other coaches. Oversaw the training, recreation, transportation and well-being of over two dozen athletes.- Occupation requires the ability to communicate and be hands-on with athletes and to be constructive in solving their personal ailments and concerns. - Collaboration with other coaches and faculty to enhance the experience of the athletes and follow the tasks and guidelines provided by the head coach is required.- Coached 2012 California State Division 1 Cross Country Individual Champion- CPR certification obtained July, 2012. Coaching certification obtained July, 2012.

Responsible for providing exceptional customer service at a small, family-style restaurant which boasts a large and consistent clientele.- Duties involve sanitary upkeep of the facility, serving meals to customers, processing food orders, answering phone calls, utilizing a cash register and the completion of other various tasks assigned by the restaurant manager.- Position demands the use of both teamwork and leadership skills in order to coordinate tasks and produce excellent customer service in a fast-paced environment.

Utilize leadership and teamwork skills in order to provide maintenance for NCAA-sanctioned athletic events, while serving as a representative of the university by establishing a professional and hospitable environment for a large and diverse group of spectators.- Collaboration with supervisors and fellow event staff employees to perform a variety of tasks, including ticket sales, crowd control, customer service, event support, and the preparation and upkeep of facilities.- Provided service to crowds amassing to as large as a 2011 NCAA Soccer-leading 13,822 people in a single game.

Assistance of administrative duties, including record filing, compilation of data into Microsoft Excel manuscripts, handling phone calls in the absence of the office holder, running errands on the office holder’s behalf, and the completion of a variety of projects needing to be attended to.