Manage / implement a product stability program under current regulations; manage implementation of FDA requirements post 510(k) clearance

COMPANY	POSITION HELD	DATES WORKED
(Confidential)	Staff Scientist I	8/1992 - Present

SCHOOL	MAJOR	YEAR	DEGREE
Georgian Court College	Biology	2000	Master Degree
Marywood College	Biology		Bachelor Degree

Highlights:

Charged with developing Standard Operating Procedures (SOPs) from inception for software and device verification and validation for a global leader in homeostasis management and point-of-care (POC) testing. Working with minimal management guidance, sought training and certification via the American Software Testing Qualifications Board (ASTQB) and International Software Testing Qualifications Board (ISTQB). Utilized training to development the company’s first SOPs for the verification and validation process. Subsequently employed these SOPs in project-managing verification and validation testing of 7 new coagulation analyzers and 5 data management software applications by a team of 6 biomedical research/development and software engineering personnel, including close cooperation with external vendor of a web-based application on issues relating to compatibility with devices as well as configuration and connectivity options. • Undertook development and implementation of processes and SOPs for a new product stability program in response to a U.S. Food & Drug Administration (FDA) directive identifying critical deficiencies in existing program. Conducted gap analysis of existing program to identify missing components and deficiencies in light of applicable regulatory guidelines and wrote new SOPs ensuring full-compliance of company’s reagent stability monitoring program with ISO 13640 and CLSI EP25-A standards – including procedures for additional stability testing for simulated transport studies, accelerated studies at varying temperatures, in-use studies, and expanded real-time and room temperature stability studies. Additionally, developed formal Quality Plan detailing methodology for program implementation and collaborated with Biomedical Quality Control Department in stability program one-year phase-in based on product requirements. • Conducted field training and support initiatives. Included among these were training technical personnel of a major metropolitan area research and teaching hospital on use of in-vitro coagulation monitors and software applications and on-site collaboration with a hospital’s head perfusionist and staff on test techniques and troubleshooting to resolve technical issues with diagnostic results during cardiac-catheterization procedures. Recognized by employer for superior performance associated with data submission and software verification-validation of a new micro-sample coagulation analyzer via receipt of Premier Performer Award – just the second employee company-wide to receive this distinction.

Companies I like:

medical device companies; adjunct college professor; education manager within a company

Software Verificaion and Validation
Writing Standard Operating Procedures
Conducting Training across technical support staff, sales and marketing staff and external vendors
Completing Technical File submissions for Regulatory compliance
Developing and executing validation protocols and scripts for medical devices, diagnostic tests, and software
knowledge of Good Manufacturing Process (GMP) documentation including master device records and device history records as well as quality system regulations under FDA 21 CFR Part 820, 801, and 809; ISO 10005-2005, 18113-2009, and 15223-1; and I.S. EN 1364
Phlebotomist
Writing and reviewing product specification documents and product labeling including package inserts, box labeling, operator manuals, and training guides.

• Product Quality Support
• Product stability
• medical device software validation
• adjunct professor_biology

Senior Scientist with a distinguished twenty-plus year professional career in planning and project-managing testing and quality management initiatives supporting the development of medical devices and diagnostic assays. Industry background supplemented and enhanced by experience in educating students Core competencies include: • Verification/Validation Studies • Resource Allocation • Project Management • Study/Master Test Planning • Protocol Development • Standard Operating Procedures (SOPs) • Data Equivalence Testing • User Acceptance Testing (UAT) • Reliability Testing • Stability Testing • Alpha Clinical Protocols • Good Manufacturing Processes (GMPs) • Product-Process Risk Assessment • Quality Control/Management • Quality System Regulatory Compliance • High-Performance Team Building • Training/Development • Information Management A creative, motivated analyst, communicator, facilitator, and leader with a resolute detail orientation, the unique ability to communicate and collaborate with scientific and management personnel, and a verifiable record of achievement in employing diverse resources in the timely completion of projects and attainment of objectives.