Experience

Assurea

• United States
• Biotechnology Research
• 1 - 100 Employee

• Principal Consultant

  • May 2022 - Present



Bristol Myers Squibb

• United States
• Pharmaceutical Manufacturing
• 700 & Above Employee

• Validation Engineer I - Computerized Equipment

  • Jan 2020 - Apr 2022

  · Collaborate with system owners and quality groups to coordinate and execute validation activities · Engage with laboratory equipment vendors to implement instrument software packages · Identify computer systems controls to comply with local policies for data integrity and Part 11 compliance · Review and contribute to governing policies related to equipment qualification · Maintain qualification/validation documentation (protocols, reports, schedule) in compliance with policy · Facilitate both regularly scheduled and change-based re-qualification testing · Develop, execute and summarize equipment qualification testing protocols and reports · Develop documentation of requirements and specifications based on intended use (e.g. user requirements specifications, configuration specifications, etc.) · Provide support and training to validation and system owner groups as needed to facilitate validation activities Show less



Genentech

• United States
• Biotechnology Research
• 700 & Above Employee

• Equipment Qualification & Validation Analyst (PPD Contractor)

  • Oct 2017 - Jan 2020

  • Qualified lab software and analytical equipment such as UHPLC, LCMS, ICP-MS, ICP-OES, TruScan Raman, UV-Vis, Dissolution equipment ensuring compliance with GMP guidelines • Wrote, edited & implemented validation protocols, SOPs, Quality Project Plans necessary for GMP activities & compliance • Maintained GMP status of all 200 analytical instruments and data integrity standards • Commissioned and decommissioned complex instruments used in analytical chemistry • Worked with Quality Engineers to build a resilient audit trail, in preparation for FDA results Show less



City of San José

• United States
• Government Administration
• 700 & Above Employee

• Recreational Leader

  • May 2015 - Mar 2018



Baxter International Inc.

• United States
• Medical Equipment Manufacturing
• 700 & Above Employee

• Manufacturing Technician

  • Jan 2017 - Oct 2017

  • Supported several local manufacturing operations i.e. production of Hemostatic Matrix (FLOSEAL) and warehouse • Maintained thorough, accurate and detailed documentation of all processes in accordance with SOPs and in batch records and databases following GDP/GMP guidelines in line with ISO 13485 • Improved and maintained integrity and quality systems through the production equipment such as the MultiVac as part of the Total Productive Maintenance (TPM) team • Supported several local manufacturing operations i.e. production of Hemostatic Matrix (FLOSEAL) and warehouse • Maintained thorough, accurate and detailed documentation of all processes in accordance with SOPs and in batch records and databases following GDP/GMP guidelines in line with ISO 13485 • Improved and maintained integrity and quality systems through the production equipment such as the MultiVac as part of the Total Productive Maintenance (TPM) team



Bon Apetit

• United Kingdom
• 1 - 100 Employee

• Associate

  • Aug 2016 - Jan 2017



Coach

• United States
• Retail Apparel and Fashion
• 700 & Above Employee

• Sales Associate

  • Apr 2012 - Aug 2015



Hands-On-Care

• United States
• Alternative Medicine
• 1 - 100 Employee

• Receptionist, Therapist Aide

  • Jan 2015 - May 2015