Quality Assurance Consultant - Growth Axis Group - Remote (CA)
(2025-12)
- Assess existing quality systems, processes, and controls to identify gaps, risks, and opportunities for improvement
- Provide expert guidance on compliance requirements and quality best practices to cross-functional teams and leadership
- Review, create, and revise quality documentation, including SOPs, work instructions, and policies
- Support supplier audits; prepare audit documentation and lead remediation efforts
Senior Quality Specialist/Good Manufacturing Practices (CAPA Analyst) - Abbott Diabetes Care - Alameda, CA
(2019-08 - 2024-08)
- Directed end-to-end processing of nonconformance investigations in TrackWise, coordinating cross functional teams to evaluate events, determine impact, and drive timely resolution
- Utilized various methodologies and root cause analysis tools such as Fishbone/Ishikawa diagrams, 5 Whys, and techniques to identify and resolve nonconformance issues
- Managed and maintained quality records within TrackWise and EDMS, including nonconformances, CAPAs, audit evidence, and investigation documentation to ensure data integrity and compliance readiness
- Documented nonconformance events, supporting evidence, investigation outcomes, and action plans in TrackWise in accordance with site quality procedures and regulatory requirements
- Partnered with Subject Matter Experts to ensure investigations aligned with CAPA requirements, risk assessments, and quality system expectations
- Led cross functional team discussions to implement corrections, corrective actions, and preventive actions (CAPAs) to mitigate recurrence of quality issues
- Verified compliance of SOPs, Quality Control procedures, and investigation documentation with FDA regulations, ISO standards, and industry guidelines
- Supported internal and external audits by providing TrackWise records, investigation summaries, and compliance documentation to auditors and Quality leadership
- Evaluated quality system processes and identified opportunities to improve investigation efficiency, documentation accuracy, and compliance procedures
Senior Coordinator Calibration, QA Engineering Support - Abbott Diabetes Care - Alameda, CA
(2007-02 - 2019-08)
- Managed the site Equipment and Calibration program, coordinating on-site and off-site calibrations to ensure equipment compliance, operational readiness, and uninterrupted manufacturing support
- Served as the sole QA team member authorized to initiate calibration-related nonconformance records in TrackWise, ensuring timely documentation, escalation, and investigation of out-of-tolerance events
- Initiated and tracked calibration nonconformances in TrackWise, including impact assessments, supporting evidence, and coordination with cross functional stakeholders for resolution activities
- Administered the site's Electronic Calibration Management System (Maximo), including maintenance of equipment records, approval of equipment inclusion forms, and review of out-of-tolerance events
- Verified calibration certificate accuracy against equipment specifications, tolerance requirements, and quality standards to ensure compliance with GMP and regulatory expectations
- Collaborated with Engineering, Manufacturing, Clinical, and Quality teams to evaluate calibration discrepancies and support corrective and preventive action activities
- Performed and reviewed First Article Inspections (FAIs), communicating approvals and rejections to the Artwork & Packaging group and external suppliers to maintain product quality standards
- Presented quarterly calibration metrics and KPIs to management and cross functional teams, identifying trends, compliance risks, and opportunities for continuous improvement
- Utilized SharePoint and Agile EDMS platforms to route, review, and approve controlled document changes in compliance with document control procedures and regulatory standards
- Built strong cross functional partnerships across departments and project teams to support quality system effectiveness and efficient resolution of calibration and compliance issues
R&D Calibration Coordinator, Engineering Associate - Abbott Diabetes Care - Alameda, CA
(2004-10 - 2007-02)
- Applied engineering standards to effectively extract, analyze, and process technical data and findings to support R&D activities
- Managed equipment calibration activities and controlled inventory of assembly parts to support R&D test builds and meet project timelines
- Established and maintained the Engineering Standards Library within the R&D organization to improve standardization and document accessibility
- Collaborated closely with the Quality team to support the site calibration program and ensure accurate, compliant, and timely calibrations for R&D equipment
- Initiated calibration-related nonconformance records (NCs) for the R&D Engineering department and supporting investigation details within the quality system
- Partnered with the QA Manager to identify and coordinate appropriate cross functional stakeholders, Subject Matter Experts, and engineering personnel required for nonconformance investigations and resolution activities
- Supported investigation activities by providing technical data, equipment history, and engineering analysis to assist with root cause determination and corrective action development
- Assisted in ensuring accurate and reliable test data by supporting multiple teams throughout the R&D organization and maintaining calibrated, compliant equipment systems
