Experience

Forza Pharma Consulting, LLC

• United States
• Biotechnology Research
• 1 - 100 Employee

• Principal

  • May 2019 - Present

  San Francisco Bay Area -Developed proposals for Validation, Quality Assurance, and Project Management projects/roles. -Project management of in-house and Software-as-a-Service computerized systems implementations. -Authored Change Controls for new greenfield facility (new manufacturing suites and supporting utilities, QC laboratories and supporting utilities, GMP warehouse, UL ComplianceWire ELMS, Veeva Vault modules, Okta Single Sign-on integrations, Veeam implementation, AD Audit Plus… Show more -Developed proposals for Validation, Quality Assurance, and Project Management projects/roles. -Project management of in-house and Software-as-a-Service computerized systems implementations. -Authored Change Controls for new greenfield facility (new manufacturing suites and supporting utilities, QC laboratories and supporting utilities, GMP warehouse, UL ComplianceWire ELMS, Veeva Vault modules, Okta Single Sign-on integrations, Veeam implementation, AD Audit Plus implementation). -Authored commissioning plans for new GMP facility. -Authored, reviewed, and approved executed Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols and reports for new and relocated GMP controlled temperature units (freezers, refrigerators, ovens, shaker incubators, and stability chambers, etc), computerized and non-computerized QC analytical systems (DNA sequencer, CFU counter, plate reader, cell counter, Real Time PCR, Biological Safety Cabinets, etc), GMP utilities (process gases and HVAC), and other computerized systems (Veeva Vault QualityDocs, Quality Management System (QMS), Electronic Trial Master File (eTMF), and Regulatory Information Management (RIM), Okta Single Sign-on, UL ComplianceWire ELMS, Veeam, AD Audit Plus). -Implemented Periodic Review program. -Authored Periodic Review Reports (PRR), User Requirements Specifications (URS), System Risk Assessments (SRA), System Impact Assessments (SIA), Operation and Use SOPs, Administration and Maintenance SOPs, Installation Qualification (IQ) protocols, Operational Qualification (OQ) protocols, and Performance Qualification (PQ) protocols, Re-Qualification (RQ) protocols, and Validation Summary Reports (VSR) for cleanrooms, GMP HVAC systems, and computerized and non-computerized QC analytical instruments and supporting systems. -Performed Data Integrity assessments against 21 CFR Part 11 and EU Vol 4 Annex 11 requirements for computerized QC analytical instruments. Show less



Delta Project Management, Inc.

• Validation Engineer II

  • Nov 2018 - Aug 2019

  San Francisco Bay Area



Delta Project Management

• United States
• Biotechnology Research
• 1 - 100 Employee

• Validation Engineer I

  • Nov 2016 - Nov 2018

  San Francisco Bay Area Developed User Requirement Specifications (URS) and System Risk Assessments (SRA). Developed and executed Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Initiated and resolved IQ/OQ/PQ related discrepancies and deviations. Prepared Validation Summary Reports (VSR) and Turnover Packages (TOP). Developed and revised Standard Operation Procedures (SOP) and Master Batch Records (MBR). Experienced in commissioning and… Show more Developed User Requirement Specifications (URS) and System Risk Assessments (SRA). Developed and executed Commissioning, Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification (PQ) protocols. Initiated and resolved IQ/OQ/PQ related discrepancies and deviations. Prepared Validation Summary Reports (VSR) and Turnover Packages (TOP). Developed and revised Standard Operation Procedures (SOP) and Master Batch Records (MBR). Experienced in commissioning and qualification of ISO classified rooms, refrigerators, freezers, incubators, stability chambers, ovens, furnaces, isolators, heat sealers, high shear mixers, atomizers, spray dryers, exhaust filter skids, utility control skids, process control panels, jet mills, and powder feeders. Experienced with providing engineering support for Manufacturing Operations and Quality Assurance in investigating deviations and performing periodic reviews. Show less



Boehringer Ingelheim

• Germany
• Pharmaceutical Manufacturing
• 700 & Above Employee

• QA Validation Coordinator

  • Feb 2016 - Nov 2016

  Fremont, CA Developed and revised Validation protocols to meet local and global standards. Reviewed and summarized executed cleaning protocols in reports. Verified manufacturing conformance during cleaning activities in a GMP environment. Prepared large volumes of execution sheets, sample templates and sample identifiers to Manufacturing for Cleaning Validation activities. Reported QC sample results to project managers. Lead and facilitated inter-and intra-departmental meetings and discussions. Created… Show more Developed and revised Validation protocols to meet local and global standards. Reviewed and summarized executed cleaning protocols in reports. Verified manufacturing conformance during cleaning activities in a GMP environment. Prepared large volumes of execution sheets, sample templates and sample identifiers to Manufacturing for Cleaning Validation activities. Reported QC sample results to project managers. Lead and facilitated inter-and intra-departmental meetings and discussions. Created, improved, and maintained project management tools. Trained several coworkers in on-site LIMS, document change control procedures, and Good Documentation Practices (GDPs). Show less



Zosano Pharma

• United States
• Pharmaceutical Manufacturing
• 1 - 100 Employee

• Manufacturing Associate III

  • Jul 2015 - Feb 2016

  Fremont, CA Coordinated with Supervisor and Lead to support Manufacturing Operations in a team of thirty full time and temporary employees. Verified manufacturing conformance in a GMP/ISO 11608 environment during manufacturing reviews, cleaned and maintained work space in a state of audit readiness in accordance with ISO 5/Class 100 cleanroom standards, prepared areas for Line Sign Off, handled Active Pharmaceutical Ingredients (APIs) and formulations during critical processes (automated and… Show more Coordinated with Supervisor and Lead to support Manufacturing Operations in a team of thirty full time and temporary employees. Verified manufacturing conformance in a GMP/ISO 11608 environment during manufacturing reviews, cleaned and maintained work space in a state of audit readiness in accordance with ISO 5/Class 100 cleanroom standards, prepared areas for Line Sign Off, handled Active Pharmaceutical Ingredients (APIs) and formulations during critical processes (automated and semi-automated), and prepared in-process samples for QC analysis. Prepared material for inter-departmental custody transfers, requested and received materials via Supply Chain, reviewed and updated Standard Operating Procedures (SOPs) for QA, and assisted R&D operations with projects and test methods. Show less



Thermo Fisher Scientific

• United States
• Biotechnology Research
• 700 & Above Employee

• Senior Manufacturing Technician

  • May 2014 - Jul 2015

  Pleasanton, CA Coordinated with Supervisors to direct headcount of 25 full time and temporary employees, established and adjusted short and long term priorities, verified manufacturing conformance in an GMP and ISO 13485/9001 environment during final manufacturing reviews, investigated and documented planned/unplanned nonconformance through Trackwise QMS, created, assigned, and completed CAPAs in Trackwise QMS, maintained and reported manufacturing performance through metrics, coordinated equipment… Show more Coordinated with Supervisors to direct headcount of 25 full time and temporary employees, established and adjusted short and long term priorities, verified manufacturing conformance in an GMP and ISO 13485/9001 environment during final manufacturing reviews, investigated and documented planned/unplanned nonconformance through Trackwise QMS, created, assigned, and completed CAPAs in Trackwise QMS, maintained and reported manufacturing performance through metrics, coordinated equipment calibrations and reported results. Maintained work space in a state of audit readiness in accordance with site and corporate policies. Identified and evaluated potential hazards, as well as assigned and completed CAPAs as the Area Safety Coordinator in a CAL OSHA VPP Star certified environment. Also acted as the Continuous Improvement Committee Lead. Created and revised several protocols to fit practices through SAP and Agile. Proficiently trained operators in technical procedures.

• Manufacturing Technician

  • Oct 2012 - May 2014

  Pleasanton, CA Met daily goals in an ISO 13485/9001 environment. Operated various instruments including: liquid handling instruments such as Star Hamiltons, Velocity 11 Bravos, Biomek FXs, and Biomek 2000s, Applied Biosystems 3900 DNA Synthesizers and MerMade 192s to manufacture oligonucleotides, and BioMicroLabs XL20 for tube taring and measuring the liquid volume final product. Implemented continuous improvement projects for efficiency, quality, and working conditions.



University of California, Davis

• United States
• Higher Education
• 700 & Above Employee

• Undergraduate Researcher

  • Dec 2011 - Aug 2012

  Davis, CA My role in this laboratory included preparing YPD media to generate S. cerevisiae cultures from Open Biosystems Yeast TAP-Tagged collection, exposing these cultures to varying concentrations of oxidants, extracting and purifying proteins of interest via TCA precipitation, quantifying protein concentration by the BCA assay and use of a Varian Cary 50, Bio UV-Vis Spectrophotometer with a Varian Cary 50 MPR Microplate Reader, and identifying proteins susceptible to oxidation via a “semi-dry”… Show more My role in this laboratory included preparing YPD media to generate S. cerevisiae cultures from Open Biosystems Yeast TAP-Tagged collection, exposing these cultures to varying concentrations of oxidants, extracting and purifying proteins of interest via TCA precipitation, quantifying protein concentration by the BCA assay and use of a Varian Cary 50, Bio UV-Vis Spectrophotometer with a Varian Cary 50 MPR Microplate Reader, and identifying proteins susceptible to oxidation via a “semi-dry” protein immunoblot (Western Blot), imaged by a Fujifilm Luminescent Image Analyzer (LAS-3000).

• Student Assistant II

  • Nov 2011 - Aug 2012

  Davis, CA My role involves preparing bacterial artificial chromosomes for high-throughput fingerprinting. I prepare LB media, inoculate several E. coil bacterial libraries in 96-well blocks, isolate BAC DNA, transfer samples using a Thermo Scientific Matrix PlateMate 2x3 Automated Workstation, digest BAC DNA with an enzyme cocktail, label DNA fragments with fluorescent dyes, and then run the samples in an Applied Biosystems 3730xl DNA Analyzer.

• Intern

  • Dec 2008 - Nov 2009

  Davis, California As member of the first team representing the University of California, Davis competing in the International Genetically Engineered Machines Competition in 2009, our project explored a possible therapeutic treatment for individuals with Celiac Disease, and involved creating an inducible biological secretion system and constructing a biological pH sensor to limit this secretion system to the stomach. The team won a bronze medal.



University of California, San Francsico

• United States
• Medical Practices

• Intern

  • Jun 2008 - Nov 2008

  San Francisco Bay Area Participated in the International Genetically Engineered Machines Competition in 2008, our project involved generating a chromatin remodeling system in S. cerevisae that would inducibly silence specific loci in the genome. The team won Best in New Application Area and a bronze medal.