Experience

ComplianceQuest

• United States
• Software Development
• 200 - 300 Employee

• Senior Solutions Consultant

  • Oct 2021 - Present

  QMS module configuration and implemention including Change Management, Documents, Training, Nonconformance, CAPA, Complaints, Supplier, and Audit. QMS module configuration and implemention including Change Management, Documents, Training, Nonconformance, CAPA, Complaints, Supplier, and Audit.



MasterControl

• United States
• Software Development
• 700 & Above Employee

• Project Consultant

  • Oct 2018 - Mar 2020

  Configuring and upgrading QMS modules for assigned clients including Complaints, Nonconformance, Deviation, CAPA, Change Control. Guidance from project initiation to user acceptance testing. Configuring and upgrading QMS modules for assigned clients including Complaints, Nonconformance, Deviation, CAPA, Change Control. Guidance from project initiation to user acceptance testing.



Achaogen

• United States
• Biotechnology Research
• 1 - 100 Employee

• QMS Project Manager

  • Mar 2018 - Aug 2018

  Responsible for advancing Process solutions to move the organization to an electronic QMS. Implemented Customer Complaints solution ahead of product launch. Responsible for advancing Process solutions to move the organization to an electronic QMS. Implemented Customer Complaints solution ahead of product launch.



Sutro Biopharma, Inc.

• United States
• Biotechnology Research
• 100 - 200 Employee

• Senior Quality Specialist

  • Apr 2016 - Mar 2018

  Engaged in all Quality system activities related to GMP manufacturing. Primary MasterControl sysadmin responsible for workflow configuration to ensure alignment with SOPs and training program. Engaged in all Quality system activities related to GMP manufacturing. Primary MasterControl sysadmin responsible for workflow configuration to ensure alignment with SOPs and training program.



MedQIA, LLC

• United States
• Biotechnology Research
• 1 - 100 Employee

• QA/QC Lead

  • 2013 - 2016

  Planned and conducted multiple internal audits per quarter. Actively involved in more than 10 Sponsor qualification audits and one FDA inspection. Gained approval for MasterControl as eQMS solution and developed implementation strategy. Managed Document Control and Training. Planned and conducted multiple internal audits per quarter. Actively involved in more than 10 Sponsor qualification audits and one FDA inspection. Gained approval for MasterControl as eQMS solution and developed implementation strategy. Managed Document Control and Training.



Actelion (now Janssen Pulmonary Hypertension)

• Switzerland
• Pharmaceutical Manufacturing
• 500 - 600 Employee

• Contract Coordinator

  • 2010 - 2012



XDx is now CareDx, Inc.

• Biotechnology Research
• 1 - 100 Employee

• Technical Operations Associate

  • 2006 - 2009