Yolanda Holden
Quality Assurance Specialist | GMP Compliance | Batch Record Review | CAPA | Pharma & Biotech
- Role
- Manufacturing Quality Assurance Specialist at Novartis
- Location
- Durham, NC, US
- LinkedIn followers
- 500 followers
About Yolanda Holden
Ensuring Quality & Compliance in Biotech Manufacturing | GMP | Regulatory Compliance |…
Experience
Manufacturing Quality Assurance Specialist
Dec 2024 — Present · Durham, NC, US
Driving Quality Excellence in Biologics Manufacturing:As a Manufacturing Quality Assurance Specialist, I ensure compliance with GMP regulations, FDA, and EU standards while providing quality oversight across large-scale manufacturing operations. I collaborate with cross-functional teams to maintain product integrity, regulatory adherence, and continuous improvement in biotech production.Key Contributions & Impact:• Ensured batch release compliance by overseeing batch record reviews, quality audits, and shop floor inspections, ensuring adherence to regulatory standards.• Facilitated regulatory inspections and internal audits, maintaining meticulous documentation and compliance with quality management systems (QMS).• Led deviation and CAPA investigations, driving root cause analysis and implementing corrective actions to enhance quality control and manufacturing efficiency.
Education
North Carolina Central University
Bachelor of Science - BS, Criminal Justice/Law Enforcement Administration
1993 — 1997
Find verified contacts for anyone on LinkedIn
Unifers gives sales teams verified emails and direct dials, enriched profiles, and outreach that lands in the inbox.
Free plan included · No credit card required
This profile is compiled from publicly available professional sources. Unifers is not affiliated with or endorsed by LinkedIn. Request removal of this profile.