Deanna Richards

Qualified Quality Assurance Specialist with over 19 years of comprehensive experience in interpreting and implementing Quality Assurance and Compliance standards, with 12 of those years managing the site's Equipment and Calibration program. Experienced reviewing document change requests and SOPs to ensure proposed changes were in compliance with cGMP (Current Good Manufacturing Practice) regulations and company standards. Possesses strong analytical skills and in-depth knowledge of QA tools and methodologies.

Committed to improving overall business processes and ensuring high standards of quality and compliance.

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

Vocational Certificate - Medical Assistant (2003-05)