Emily Norton
Mt. Royal
Summary
Detail-oriented and results-driven Quality Assurance professional with over 6 years of experience in regulatory compliance, internal audits, and quality systems within plasma services. Proven ability to lead audit readiness, manage corrective actions, and collaborate across departments to ensure compliance with FDA, CLIA, and GMP standards. Seeking to leverage expertise in audit coordination and regulatory documentation to contribute to Cooper Health’s mission of excellence in healthcare compliance.
Overview
7
7
years of professional experience
Work History
Quality Assurance Supervisor
Octapharma Plasma Inc.
11.2022 - 06.2024
- Led internal and external audit preparation, ensuring timely and compliant responses
- Conducted quality compliance audits across donor processing, plasma collection, and shipment
- Analyzed tracking/trending data to identify unfavorable trends and implemented corrective actions
- Managed staff scheduling, recruitment, performance evaluations, and disciplinary actions
- Facilitated cross-functional meetings to review policy updates and center performance
Assistant Manager of Quality
CSL Plasma
09.2020 - 11.2022
- Oversaw implementation of Quality Systems and ensured audit readiness for FDA, GHA, CLIA
- Conducted root cause investigations and developed CAPAs with effectiveness checks
- Monitored KPIs and led internal audits to ensure compliance with regulatory standards
- Authored and submitted documentation for audit responses and appeals
Quality Training Specialist
CSL Plasma
02.2020 - 09.2020
- Managed training programs and SOP compliance across center operations
- Supported audit readiness and collaborated on continuous improvement initiatives
Quality Specialist
CSL Plasma
08.2019 - 02.2020
- Performed root cause analysis and developed corrective actions based on performance indicators
- Represented center during audits and coached staff on compliance and training systems
Quality Lead Technician
BioLife Plasma Services
12.2017 - 04.2019
- Conducted monthly internal audits and tracked deviations in operating procedures
- Supported audit hosting and ensured GMP compliance in donor and product handling
Medical Screener
BioLife Plasma Services
09.2017 - 12.2017
- Performed donor screening and sample testing; maintained accurate donor records
Education
Bachelor of Arts - Business Administration And Management
Lindenwood University
Saint Charles, MO05-2020
Skills
- Corrective action planning
- Auditing techniques
- Quality inspection
- Quality control management
- Internal & External Audit Coordination
- Root Cause Analysis & CAPA
- Regulatory Compliance (FDA, CLIA, GMP)
- Quality Systems & SOP Management
- Staff Training & Development
- Risk Analysis & KPI Monitoring
- Documentation & Reporting
Timeline
Quality Assurance Supervisor
Octapharma Plasma Inc.
11.2022 - 06.2024
Assistant Manager of Quality
CSL Plasma
09.2020 - 11.2022
Quality Training Specialist
CSL Plasma
02.2020 - 09.2020
Quality Specialist
CSL Plasma
08.2019 - 02.2020
Quality Lead Technician
BioLife Plasma Services
12.2017 - 04.2019
Medical Screener
BioLife Plasma Services
09.2017 - 12.2017
Bachelor of Arts - Business Administration And Management
Lindenwood University
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