Arizona Smith
Chandler,AZ
Summary
Results-driven Training and Quality Systems Leader with a decade of experience in FDA/ISO-regulated environments. Extensive people leadership responsibilities. Proven track record in developing, implementing, and managing compliance-driven training programs. Strong expertise in QMS, eQMS administration, and process optimization. Skilled in fostering cross-functional collaboration, spearheading change initiatives, and upholding regulatory excellence under FDA 21 CFR Part 11, CLIA, CAP, and ISO 13485 standards.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Supervisor, Competencies & Training
Caris Life Sciences
05.2022 - Current
- Lead strategic alignment of training programs with QMS, business objectives, and regulatory requirements.
- Develop and manage multi-modal training across business units, including new hire onboarding and ongoing competency.
- Supervise training systems, instructional design, and LMS processes for compliance under 21 CFR Part 11.
- Conduct gap assessments, risk analyses, and curriculum updates to improve training efficacy and audit preparedness.
- Collaborate cross-functionally to manage change initiatives, create performance metrics, and support regulatory inspections.
- Coach team members and manage training vendors to ensure seamless execution of learning initiatives.
Quality Assurance Analyst
Caris Life Sciences
06.2021 - 05.2022
- Ensured compliance with FDA, CLIA, CAP, ISO, and NYS regulations through internal audits and SOP oversight.
- Managed ~5,000 SOPs and other supporting documentation.
- Partnered with stakeholders on data analysis, CAPA planning, and Management Review processes.
- Streamlined QA processes for increased efficiency and reduced time spent on redundant tasks.
Quality Control Specialist, Reagent QC
Caris Life Sciences
02.2020 - 06.2021
- Conducted QC testing of reagents and materials; released inventory based on regulatory criteria.
- Captured and trended quality data to inform stakeholders and implement compliance improvements.
- Identified areas for process improvement and collaborated with cross-functional teams.
- Provided regular updates to team leadership on quality metrics by communicating consistency problems or production deficiencies.
- Participated in regular management review meetings, providing updates on quality control performance and suggesting areas for improvement.
Clinical Lab Specialist III
Creative Testing Solutions
01.2016 - 01.2020
- Supported laboratory operations by leading test validation and mentoring junior staff.
- Maintained audit readiness and executed lab tests aligned with SOPs and regulatory guidelines.
- Provided training to new staff members on laboratory procedures, safety protocols, and best practices for efficient operation.
- Supported continuous improvement initiatives within the lab by identifying areas of potential growth or enhancement based on performance metrics.
Education
Master of Arts - Public Health
Grand Canyon University
Phoenix, AZ06.2016
Bachelor of Science - Biological Science
Arkansas State University
Jonesboro, AR12.2013
Skills
- Quality Systems (QMS) Leadership
- Regulatory Compliance (FDA, ISO 13485, CLIA, CAP)
- Training Program Development & Execution
- Learning Management Systems (LMS)
- Gap Assessments & Process Improvement (Lean/Six Sigma)
- Cross-Functional Stakeholder Collaboration
- Metrics & Audit Readiness
- People Leadership & Coaching
- Change Management
- SOP Development & Implementation
- EQMS Administration (MasterControl, Dot Compliance)
Certification
- Six Sigma Champion Certified – 2019-10
- Six Sigma Lean Black Belt Professional – 2019-10
Timeline
Supervisor, Competencies & Training
Caris Life Sciences
05.2022 - Current
Quality Assurance Analyst
Caris Life Sciences
06.2021 - 05.2022
Quality Control Specialist, Reagent QC
Caris Life Sciences
02.2020 - 06.2021
Clinical Lab Specialist III
Creative Testing Solutions
01.2016 - 01.2020
Bachelor of Science - Biological Science
Arkansas State University
Master of Arts - Public Health
Grand Canyon University
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