Shauna Hooper
Kennesaw
Summary
Quality Assurance Specialist with experience managing documentation systems, training lab staff, coordinating audits, and maintaining compliance with FDA, CLIA, GCLP, HIPAA, and AATB standards. Skilled in implementing quality assurance systems, managing standard operating procedures, and conducting CAPA investigations to enhance lab efficiency and accuracy.
Overview
10
10
years of professional experience
1
1
Certification
Work History
Quality Assurance Specialist
Antech Diagnostics
Atlanta
01.2024 - 04.2025
- Led QA reviews of laboratory records to ensure accuracy and regulatory compliance.
- Conducted internal audits across diagnostic labs, identifying opportunities for process improvements.
- Collaborated with cross-functional lab teams on adherence to SOPs and documentation updates.
- Provided QA training and support for inspection preparations, enhancing team readiness.
- Interpreted test results against established criteria to verify compliance with regulations.
- Investigated customer complaints related to quality issues, implementing corrective actions as needed.
- Maintained accurate records regarding inspection results and findings.
Clinical Lab Manager
Emory University Winship Clinical Trials
Atlanta
09.2019 - 07.2023
- Oversaw daily lab operations, including personnel staffing and scheduling.
- Coordinated biospecimen processing, tracking, documentation, and compliance across 20+ protocols.
- Led development of SOPs and audit readiness efforts, ensuring GCP documentation and staff training.
- Maintained full traceability of samples through effective specimen tracking.
- Ensured compliance with all regulatory standards during laboratory operations.
- Troubleshot instrumentation issues to minimize downtime as necessary.
- Managed external contract services for laboratory sample analysis coordination.
- Controlled inventory and supplies to guarantee availability of materials.
Cardiovascular Dissector/ Tissue Quality Assurance
CryoLife, Inc.
Kennesaw
05.2015 - 09.2019
- Managed review and verification of cardiovascular tissue case files for FDA and AATB compliance.
- Trained new analysts on aseptic documentation and recovery protocols.
- Collaborated with recovery and processing teams to resolve documentation discrepancies.
- Supported FDA audits and ensured accurate documentation processes.
- Conducted non-conformance investigations to uphold quality standards.
- Ensured successful processing and implantation of tissues under QA review.
Education
Bachelor of Arts - Health Science
Eastern Kentucky University
Richmond, KYSkills
- CAPA, FDA, GCLP, and GMP compliance
- Laboratory supervision
- QA/QC documentation management
- SOP development
- Internal auditing
- Regulatory compliance
- Process improvement
- Customer complaint investigation
- Team collaboration
- Inspection readiness
- Root cause analysis
- Risk mitigation
- LIMS and SAP expertise
- Oracle proficiency
- Microsoft Office skills
- Document management
- Staff training
- Effective communication
- Problem solving
- Attention to detail
- Time management
- Sampling
- Quality assurance
Certification
- Lean Six Sigma Yellow Belt
Technical Tools
- LIMS
- Oracle
- SAP
- Microsoft Office
- OpenSpecimen
- QMS platforms
Timeline
Quality Assurance Specialist
Antech Diagnostics
01.2024 - 04.2025
Clinical Lab Manager
Emory University Winship Clinical Trials
09.2019 - 07.2023
Cardiovascular Dissector/ Tissue Quality Assurance
CryoLife, Inc.
05.2015 - 09.2019
Bachelor of Arts - Health Science
Eastern Kentucky University
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