Sylvia P.
Experienced Quality Systems Professional
- Role
- Quality Audit Specialist Iii at NeoGenomics Laboratories
- Location
- Raleigh, NC, US
- LinkedIn followers
- 500 followers
About Sylvia P.
Experienced professional in a Quality Assurance and Medical Device manufacturing environment• Certified Quality Auditor and ISO 13485 Lead Auditor• Certified Six Sigma Green Belt• Extensive experience with EU’s Medical Device Regulation (MDR), FDA’s Code of Federal Regulations (CFR) part 210, 211, 820, 821• Significant experience in GMP and ISO 13845 regulated industry of medical devices • Experience and skills in process auditing, system implementation, database administration, and quality improvement; ISO 14971:2009 Risk Management • Technical expertise in microbiology and analytical laboratories in quality control testingProficient with quality system and tracking software; TrackWise, SAP, ERP Specialties: Certified Six Sigma Green Belt - 2011Certified Quality Auditor, ISO13485:2003Certified Quality Technician
Experience
Quality Audit Specialist Iii
Jan 2023 — Present · Durham, NC, US
Responsible for building and sustaining NeoGenomics Laboratories\' internal audit program. Primary contact for the internal audit program onsite in the Durham facility and across the US with all NEO Labs. Actively supports global supplier management program. Provide input to the Inspection-Readiness team for external audit activities. SME for the Internal Audit Program and supplier management during regulatory inspections.
Education
Wake Technical Community College
Associate of Science (AS), Pharmaceutical Technology
1990 — 1992
Strayer University
Bachelor of Business Administration (BBA), Management and Operations
2011 — 2014
Skills
- Dmaic
- Cqe
- Change Control
- 21 Cfr Part 11
- Six Sigma
- Quality Auditing
- Software Documentation
- Root Cause Analysis
- U.s. Food and Drug Administration (Fda)
- Design Control
- Quality Assurance
- Validation
- Minitab
- Complaint Management
- Iso Standards
- Analytical Chemistry
- Verification and Validation (V&V)
- Process Excellence
- Auditing
- Asq
- Supplier Quality
- Iso 14971
- Cqa
- Kaizen
- Good Laboratory Practice (Glp)
- Continuous Improvement
- 21 Cfr
- Corrective and Preventive Action (Capa)
- Medical Devices
- Capa
- Iso 9000
- Value Stream Mapping
- Process Improvement
- Quality System
- V&V
- Green Belt
- Standard Operating Procedure (Sop)
- Iso
- Pharmaceutical Industry
- Fda
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