Vanessa Burnett
San Diego,CA
Summary
Dynamic Quality Assurance professional with extensive experience specializing in electronic Quality Management Systems and document control. Proven track record in enhancing inspection readiness and leading successful training programs. Skilled in Veeva and MasterControl, with strong leadership and problem-solving abilities to drive quality improvements.
Overview
2026
2026
years of professional experience
Work History
Quality Assurance, Associate Director
Dermavant Sciences
2022 - Current
- System owner of electronic Quality Management System, Document Management System, and Learning Management System supporting GxP functions
- Program manager of Document Management and Training Program
- Support inspection readiness and war room activities
Quality Assurance Manager – Quality Systems and Document Control
Heron Therapeutics
01.2019 - 01.2022
- Document management lead and system administrator of eDMS, including validation activities, review of change requests, documentation review, user management, and hands on training
- Track and facilitate closure of CAPAs, Deviations, Change Controls and Training
- Support onsite audit activities and inspection readiness
Quality Assurance Associate
Helix Laboratories
01.2018 - 01.2019
- Document Control Program Manager
- Management of competency training program
- Coordinate development and facilitate CGMBS training program
- Compile submissions for various state licensure
- Manage Inspection Readiness activities
Quality Management Specialist
Human Longevity Inc.
01.2016 - 01.2017
- Provided overall support to the Quality Management System e.g., CAPA, change management, supplier management, etc
- Provided guidance to multiple teams regarding applicable ISO, QSR, CAP/CLIA regulations and standards for software development activities
- Managed technical writing staff
- System admin of eDMS, oversaw daily activities of technical writing team
Quality Systems Specialist
Quidel Corp
2015 - 2016
- MasterControl system administrator
- Responsible for the validation of eQMS modules (e.g., CAPA, Change Control, Training)
Document Control Specialist
Epic Sciences
01.2014 - 01.2015
- Used knowledge of 13485, GxP, CAP/CLIA requirements to create and maintain, process documentation and records
- Supported CAP accreditation activities and Partner studies and audits
- Performed quality processes and Good Documentation Practices training for all new hires
Skills
Electronic Quality Management, Document Management, Learning Management Systems
SmartSheet
AuditUtopia
Professional Development
- Veeva Vault Administrator: QualityDocs, QMS, Platform
- Document Management for the Pharmaceutical, Biotech, and Medical Device Industries – CFPIE
- Lead Auditor for ISO 13485 – Oriel Stat A Matrix Certificate Number 117906
- MDSAP Internal Auditing – Oriel Stat A Matrix
- Quality System Requirements and Industry Practice – AAMI
Timeline
Quality Assurance Manager – Quality Systems and Document Control
Heron Therapeutics
01.2019 - 01.2022
Quality Assurance Associate
Helix Laboratories
01.2018 - 01.2019
Quality Management Specialist
Human Longevity Inc.
01.2016 - 01.2017
Document Control Specialist
Epic Sciences
01.2014 - 01.2015
Quality Assurance, Associate Director
Dermavant Sciences
2022 - Current
Quality Systems Specialist
Quidel Corp
2015 - 2016
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