- Project Manager for computerized systems with twenty years of experience in the development, validation, implementation and administration of software applications and computerized systems including enterprise - wide business information systems, quality management systems, clinical trial management, adverse event management, automated manufacturing equipment, control and monitoring systems (SCADA), MES/ERP, analytical instruments, data management systems, IT infrastructure and web-based applications.
- Conducted business analysis and constructed business process maps to define system requirements and data flows.
- Wrote/reviewed validation documentation and procedures for use, administration and maintenance.
- Executed validation protocols and data migration validation.
- Conducted internal audits for 21CFR Part 11 compliance and validated state, data integrity assessment, CAPAs, supplier qualification, QA review of CSV documentation and change control. Created and improved computerized system validation policies, procedures and templates.
- Project Manager for the validation and often the entire computerized system implementation. Key strengths include:
- Thorough knowledge of the system development life cycle, computer technology and project management
- Experienced implementing companywide systems and working with globally dispersed project teams
- Familiar with GAMP-5, 21CFR 11, 21CFR 820, 21CFR 58, ISO 13485, ISO 14971, and 21CFR 210/211
- PMI Certified Project Management Professional, ASQ Certified Software Quality Engineer, and ASQ Certified Manager of Quality and Organizational Excellence
- Excellent technical writing skills and ability with MS Office (Word, Project, Excel, PowerPoint, Outlook and Visio)
- Expertise with project management tools (SmartSheet, MS Project)
- Six years work experience managing projects and project teams
Confidential, Oak Park, CASoftware Quality Engineer
- Conducted company-wide audit of the validated state of computerized systems and updated validation master plan
- Validation and implementation of InfoFlo ERP for host environment upgrade including data migration
- Validation and implementation of JCI Metasys for facility monitoring and alarming
- Wrote standard operating procedures for the use and the administration of TrendManager, Japan Product Label Printing System, Minitab, and JCI Metasys.
- Validation of MasterControl including data migration from legacy system: Worked with third-party consultants, STAAR IT and MasterControl to construct and validate the on-site host environment, verify the installation of application software, and review/approve/execute validation documents prepared in-house or prepared by third-party contractors.
- Initiated product labelling quality system improvements
- Project manager for product label changes for regulatory compliance and product label printing systems
- Project Manager for the implementation of TrendManager with Honeywell Electronic Data Recorder for steam sterilization batch records
- Project Manager for the implementation of Minitab for process monitoring and process improvement
Confidential, Menlo Park, CASoftware Quality Engineer
- Validation Master Plan writing for computerized systems
- Validation of Salesforce.com upgrade with SAP interface
- Wrote/revised standard operating procedures for computerized system validation and Oracle Agile PLM
- Project Manager for the validation of site-wide equipment monitoring system
Confidential, Westlake Village, CASoftware Quality Engineer
- Validation and change control for OSIsoft PI Historian and Accelrys Discoverant
- Used Trackwise, Documentum, SharePoint and HP Quality Center
Confidential, Valencia, CASoftware Quality Engineer
- Validation gap analysis and remediation of computerized quality systems related to the physical relocation of those computerized systems
- Database analysis for the migration of product complaint tracking from NetRegulus to SAP
- Revised the computer system validation program to be consistent with GAMP-5, revised procedures and templates
- Validated Camstar MES, DataFlo ERP, Oracle Agile PLM and custom software
- Validation Lead and Project Manager of Confidential Printing System upgrade for Confidential
- Validation Lead and Project manager for Confidential for clinical trial management
- Validated GxP automated manufacturing equipment used to produce spring wire guides for catheters for Confidential compliance (coiling, cutting, grinding, stamping, welding, ultrasonic cleaning, and bending machines).
Confidential, Irvine, CA
Quality Assurance Specialist
- Validated automated equipment and facilities, laboratory analytical instruments, IT infrastructure, custom software applications and Excel spreadsheets.
- Computer system validation lead for the installation of eight PLC-controlled packing lines and associated HMIs that reduced labor costs and increased throughput by using four robots to stack cases onto pallets
- Validated analytical instrumentation, including chromatography systems with Waters Millennium/Empower LIMS
- Project Manager for the migration of software applications and files from two servers running obsolete Novell software to two servers running Windows, which reduced the business risks arising from depending on obsolete technology for critical business applications
Confidential, Los Angeles, CA
Software Quality Analyst Consultant
- Project Manager for the development, validation and implementation of custom software to control and manage water distribution in Southern California:
- Automated process control software written in C that controls the flow of water through the Irvine Regulating Structure, which improved system reliability and reduced costs by eliminating the need for continuous operator attention and intervention
- Web-based application used to manage the purchase, accounting, and reporting of electric power used to pump water through the Colorado River Aqueduct, which reduced costs by automating labor-intensive manual business processes
Confidential, Thousand Oaks, CA
- Managed a team of validation engineers to implement and validate laboratory analytical instrument systems for 21CFR Part 11 compliance, including HP/Agilent chromatography systems with Chemstation LIMS
- Validation of automation control systems and the associated HMIs (PLC, DCS, SCADA), laboratory instruments, controlled-temperature chambers and data systems used in a biologics manufacturing environment
- Conducted internal audit for 21CFR 11 compliance of Process Control Department computerized systems
- Led the validation of an Emerson DeltaV Process Control System in a biotech manufacturing facility designed for the production of a billion-dollar biologic drug
- Led the validation of a GE Fanuc Cimplicity Manager software version control system, which reduced the engineering costs for maintaining software backups and installing software upgrades (Completed the validation in five months by proactively scheduling QA resources for quick document turnaround)
- Project Manager for the 21 CFR Part 11 compliance project for the metrology department. Managed the upgrade and validation of all metrology equipment, which brought the department into compliance with 21CFR Part 11.
Confidential, West Point, PA
- Managed an Oracle database of drug stability data (Used SQL scripts to load data and create reports)
- Participated in the upgrade and revalidation of a Beckman Laboratory Information Management System (LIMS)
- Created and validated Excel spreadsheets with VBA macros used to process and report laboratory data
- Used Maximo to manage equipment, equipment maintenance and equipment calibration
Confidential, Little Falls, DE
- Developed miniature gas chromatography devices based on silicon micro-machined components.
- Created new products that tripled miniature gas chromatography sales, and patented the key technologies
- Invented the fluid-lock fixed-volume injector, which improved the precision and accuracy of miniature gas chromatograph analytical results and increased sales
- Invented the fixed-volume injector with backflush capability, which expanded the market for the miniature gas chromatograph and increased sales
- Performed quality assurance reviews of environmental sample analytical data
- Conducted hazardous waste site investigations
- Setup and managed a mobile environmental laboratory and base station lab facility
- Managed hazardous waste site field investigation teams