Pharmaceutical CQV consultant specializing in Laboratory instrumentation and computer systems.

Provided support to a client with new facility startup in various roles including the following: • QC Instrumentation o Calibrated pH conductivity meters• Quality Assurance o Reviewed and approved protocols pre and post-execution for various lab equipment• Document Control o Assisted with managing documentation for protocols and calibrations• Equipment verification o Compiled lab equipment list o Verified equipment ID’s o Tagged and labeled equipment with asset ID’s and calibration ranges

Sequence Technical Development ProgramTechnical Development Program for all Sequence resources. Provides hands-on project experience at the Sequence Training Facility in the following areas:• Direct Hands-on Experience with VITEK 2 Compact• Conceptual Design Overview o Basis of Design, URS development• Project Planning Overview o Validation Plan development, Risk Assessments (FMEA), Part 11 Assessments• Detailed Design Overview o Electrical Schedules, HVAC Pressurization Plans• Implementation Overview o Equipment installation considerations (Utility Connections, Environmental Conditions, etc.) o Developed SOPs (Admin and Operational/Maintenance)• Testing Phase Overview o Introduction to Vendor Leveraging Strategies and Considerations o Test Strategies (IQ, OQ, PQ) for Laboratory Equipment o Developed and Executed IOPQ Protocol for a VITEK 2 Compact (including GDP and Discrepancy Management)• System Release and Turnover o Trace Matrix and Validation Summary Report development• Review of Part 11 Assessments and Data Integrity principles (ALCOA)• Review of Industry Guidelines and Standards (ISPE GAMP 5, USP, ISO - 17025, ISO - 9001) • Review of Applicable FDA Regulations (21 CFR part 11, 21 CFR part 210 & 211)