Experience

American Laboratories

• United States
• Manufacturing
• 1 - 100 Employee

• Process Scientist, Technical Services Specialist

  • Oct 2017 - Present



Medtronic Diabetes

• Technical Writer/Sterilization & Microbiology

  • Jun 2017 - Oct 2017

  • Writing, editing and reviewing protocols, reports and memos supporting sterilization/microbiology aspects of product development and regulatory submission for sterile medical devices.• Writing, editing and reviewing sterilization/microbiology operating procedures and material specifications for documentation updates.• Regulatory Guideline Knowledge: FDA Code of Federal Regulations (CFR) Title 21 - Part 4 Combination Products, Part 11 Electronic Records/Signatures, Part 58 Good Laboratory Practice, Nonclinical, Part 210/211 Current Good Manufacturing Practices Pharmaceuticals, Part 820 Quality System Regulation; International Conference on Harmonization (ICH) Guidelines; International Organization for Standardization Guidelines – ISO13485 Medical devices-Quality management systems, ISO17025-General requirements for the competence of testing and calibration laboratories; United States Pharmacopeia (USP); European Pharmacopoiea (Ph. Eur.)• Business Systems Knowledge: SAP Electronic Data Management System, Agile Product Lifecycle Management



Medtronic Diabetes

• Technical Documentation/Quality Assurance Specialist

  • Sep 2015 - Jan 2017

  • Reviewed and edited operating procedures, test methods, and material specifications (content, grammar, formatting, accuracy, compliance to applicable regulations and standards) for documentation updates and conversion from SAP-EDMS to Agile PLM product management system.• Wrote protocols and reports for test equipment qualification. • Carried out investigation activities, compiled data, and wrote reports for CAPA (corrective and preventive action) investigations. • Carried out a comprehensive internal audit of quality records supporting the development and FDA submission of glucose sensor/transmitter medical devices to ensure compliance with Quality System procedures and FDA requirements.• Reviewed and edited combination medical device grant proposal to JDRF (Juvenile Diabetes Research Foundation) including technical background, research, development, clinical feasibility/trial plans, regulatory submission plan, and timelines.



Natures Helper Inc

• United States
• Human Resources Services
• 1 - 100 Employee

• Accounts Payable/Receivable Specialist

  • Jun 2012 - Aug 2015

  • Administered accounts payable and receivable functions using QuickBooks™ software. • Scheduled/tracked work using HindSite field service software.• Responded promptly to both customer and service technician requests and needs. • Developed and wrote company Operations Manual; revised and edited Tech Service Manual. • Business Systems Knowledge: HindSite Field Service Software, QuickBooks • Administered accounts payable and receivable functions using QuickBooks™ software. • Scheduled/tracked work using HindSite field service software.• Responded promptly to both customer and service technician requests and needs. • Developed and wrote company Operations Manual; revised and edited Tech Service Manual. • Business Systems Knowledge: HindSite Field Service Software, QuickBooks



Medtronic Diabetes

• Technical Documentation Specialist

  • May 2008 - Apr 2012

  **This position was part-time, concurrent with Graduate School program**Developed and wrote Drug Delivery Systems department Laboratory Training Manual/Program.(Contract position concurrent with Graduate program enrollment)• Developed and wrote Laboratory Quality Systems Manual complying with ISO17025 guidelines (General requirements for the competence of testing and calibration laboratories).• Wrote, edited and reviewed regulatory compliance documentation (operating procedures and test methods), validation and engineering reports, department presentations, and other technical documentation.



Medtronic Diabetes

• Chemistry Manager

  • Aug 1999 - Jun 2007

  • Managed regulatory/quality compliance programs for development of pharmaceutical formulations and associated medical devices in the Drug Delivery Systems department. Coordinated related activities across departments and with contract manufacturing sites. • Wrote test protocols and reports, development/technical reports, and other compliance documentation. Reviewed and approved contract manufacturing documentation including master batch records. • Supervised data review and quality assurance personnel/processes to maintain compliance with current GMPs (Good Manufacturing Practices) and Quality System requirements. • Coordinated and administered all pharmaceutical stability (shelf life) assessment programs (planning, scheduling, sample accountability/distribution, data collection and summary in proprietary database).



Courtaulds Aerospace

• United States
• Chemical Manufacturing

• Product Information Supervisor

  • 1996 - 1998

  • Directed activities of regulatory compliance programs including pre-manufacture notice submissions to regulatory agencies. • Supervised generation of technical documents, hazard assessments, and review of regulatory requirements.• Coordinated implementation of proprietary software as part of transition to a new business operating system (MFG/PRO).

• Senior Research Chemist

  • 1990 - 1996

  • Conducted research and development of new polymers for applications in aerospace sealants and coatings; participated in team-oriented project planning and communication with formulating and manufacturing groups; conducted technology transfer and support at manufacturing center.