YOLANDA HOLDEN
Wake Forest,NC
Summary
Quality assurance professional known for high standards and consistent results. Extensive experience in identifying and resolving quality issues to maintain top-tier product standards. Reliable team player with focus on collaboration and adapting to evolving project needs. Proficient in quality control processes and detail-oriented analysis.
Overview
19
19
years of professional experience
1
1
Certification
Work History
Manufacturing Quality Assurance Specialist – Manufacturing Operations Support
Novartis Gene Therapies
Durham, NC
12.2024 - Current
- Perform batch record review and disposition support activities for bulk drug substance and drug product manufacturing, ensuring compliance with cGMP and GxP requirements
- Review analytical data, certificates of analysis (CoA), and supporting documentation to support batch release decisions
- Provide real-time quality oversight of manufacturing operations, ensuring adherence to procedures, regulatory requirements, and validated processes
- Serve as a key QA partner in lot disposition activities, ensuring timely and compliant product release
- Author, review, and approve GMP documentation including batch records, SOPs, and validation-related documentation
- Ensure alarm notifications are reviewed and approved in a timely manner
- Ensure alignment and integration of quality systems (Deviation, CAPA, Change Control, Validation) with batch disposition processes
- Collaborate cross-functionally with Manufacturing, QC, MS&T, Engineering, and Validation to resolve quality issues and support on-time batch release
- Support regulatory inspections and serve as QA representative for disposition-related activities
Quality Assurance Associate III, Large Scale Manufacturing
Biogen
Research Triangle Park, NC
04.2020 - 12.2024
- Conducted batch production record review and approval, ensuring completeness, accuracy, and compliance prior to disposition
- Supported batch release and disposition processes, partnering with cross-functional teams to meet production timelines
- Reviewed and approved deviations, investigations, CAPAs, and change controls, assessing product impact and supporting disposition decisions
- Evaluated deviations, investigations, and CAPAs for product impact and provided QA approval for disposition decisions
- Reviewed quality documentation, including SOPs, logbooks, and validation-related records
- Contributed to quality metrics and reporting to support management review and continuous improvement initiatives
- Led continuous improvement efforts, reducing documentation-related errors by 30% and improving right-first-time execution
- Supported FDA and global inspections, contributing to zero major observations
Quality Assurance Associate II, Large Scale Manufacturing
Biogen
Research Triangle Park, NC
11.2007 - 04.2020
- Reviewed and approved batch records and manufacturing documentation supporting lot disposition activities
- Authored and revised 50+ GMP documents, improving compliance and reducing deviations by 40%
- Supported deviation investigations, root cause analysis, and CAPA implementation impacting product quality
- Provided on-the-floor QA oversight, ensuring adherence to cGMP and immediate resolution of manufacturing issues
- Maintained quality records and supported audit readiness and regulatory compliance
Education
Bachelor of Science - Criminal Justice
North Carolina Central University
Durham, NCSkills
- Batch Release & Lot Disposition
- Batch Record, CoA & Analytical Data Review
- CGMP / GxP Compliance
- Deviation, Investigation & CAPA Management
- Change Control & Quality Systems Integration
- Validation & Qualification (Process, Equipment, Methods)
- Quality Oversight (Manufacturing, QC, Labeling)
- Risk Assessments & Technical Documentation
- Regulatory Inspections (FDA, EMA)
- Quality Metrics & Management Reporting
- Cross-Functional Collaboration
- Continuous Improvement
- Systems: SAP TrackWise PLM Oracle CMMS
- Problem-solving skills
Certification
- Aseptic Processing (Upstream & Downstream)
- AQL Certification
- Six Sigma Yellow Belt
Timeline
Manufacturing Quality Assurance Specialist – Manufacturing Operations Support
Novartis Gene Therapies
12.2024 - Current
Quality Assurance Associate III, Large Scale Manufacturing
Biogen
04.2020 - 12.2024
Quality Assurance Associate II, Large Scale Manufacturing
Biogen
11.2007 - 04.2020
Bachelor of Science - Criminal Justice
North Carolina Central University