Leah has more than 35 years of experience in research and documentation, including working in corporate research and development for nine years. Her background includes preparing specifications, validation protocols and schedules, policies and procedures, inspection and traceability records, assembly and user manuals, training exams, business proposals, grants, and marketing copy. Leah’s research experience spans biology and engineered plastics and she has expertise with design support for specialized products and QA/QC within FDA regulated environments.
- Developed validation documentation for the manufacture of pacemakers. Prepared master plan status report covering requalification, revalidation, IQ/OQ/PQs, and protocols involving lead crimpers; seal processing; electronic modules and their terminal assemblies and cleaning processes; furnaces; electrode porous tips; drug collars; lead bodies; LCR meters; sterilizers; and plasma cleaners. Inventoried and documented network programmer inspection records. Produced master list of processes, systems and equipment used in manufacturing and testing of medical devices requiring validation, and ID’d revalidation intervals. Summarized validation activity schedule of processes, systems and equipment.
- Developed methods documentation for QA support and training modules for a medical device company covering out-of-specification investigations; clean room guidelines; sterility assurance and nonconformance; D-value study testing; EtO sterilization; and environmental control of manufacturing areas, contract manufacturers, service providers, and microbiology labs.
- Developed validation documentation for blood warmers, cell washers, centrifuges, refrigerants, dielectric heat sealers, strip washers, and tube welders.
- Prepared massive pharmaceutical database for a medical diagnostics company, organizing and classifying some twenty disciplines of drug classes, reagents, and drug testing equipment categorized under different methods, constituent units and temperature.
- Transformed hardcopy production line training modules into automated electronic exams for a medical supplies manufacturer. Exams covered channel swaging; QA of a wide variety of suture materials; crock testing of suture coatings; winding techniques; record keeping; Mullen burst test of meshes; and calibration of measuring instruments for a wide variety of surgical needles. Edited exams in Spanish for a Puerto Rico subsidiary.
- Prepared a 500-page policies and procedures manual for dialysis administration. Documented every operation performed within the center in order to meet certification requirements, including dialyzer use, residual Renalin® testing, water quality control, fistula cannulation, and heparin anticoagulation. Designed 30 complex forms to be used by nurses interviewing patients and for maintaining inventory.
- Researched cryogenic applications of polymeric materials on turbopumps and fuel ducts. Conducted failure analyses; implemented new materials to accommodate environmental regulations; prepared three specifications for insulating turbopumps on Space Shuttle engines. Prepared reports summarizing failure analyses of bearing cages within these turbopumps. Prepared weekly status reports for design support work on fuel and oxidizer systems insulation. Summarized thermal cycling and ASTM mechanical testing results.
- Miscellaneous: RAVG, Inc. (aviation radio system installment manual); Nova Consulting (environmental engineering project summaries); Florida Power & Light (utilities training module); UM School of Medicine (HR communications and instruction booklet); Health Studies Institute (healthcare training modules); master’s thesis (ASTM mechanical testing of composite materials).
- Validation Engineer – BioTeknica, Inc.
- Validation Document Support – Cordis Corporation
- Quality Control Testing Support – Ethicon Corporation
- Validation Support/Documentation – American Red Cross
- Validation Support/Documentation – Telectronics Pacing Systems, Inc.
- Database Technician – Baxter Healthcare Corporation
- Technical Writer – Health Studies Institute
- Nonmetallic Materials Engineer – Rockwell International
- Materials Testing Engineer – Delsen Testing Laboratories
- Polymer Scientist/Intern – Allied-Signal
- M.S., Polymer Science – Georgia Tech
- B.S., Biology (Honors) – University of Texas