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@danielvh
Quality assurance specialist driving compliance, audits, and continuous improvement.
I am a dedicated quality assurance professional with extensive experience in manufacturing and pharmaceutical quality systems, auditing, and regulatory compliance. I lead batch record reviews, internal and external audits, and liaise with regulatory agencies to ensure cGMP and industry standard adherence.
My background includes deviation management, root cause analysis, and cross-functional collaboration supporting biologics and vaccine manufacturing. I have implemented quality management systems, overseen change control and documentation, and used tools like Veeva Vault, Oracle, and Tableau to support quality operations.
I also bring leadership experience managing teams, training staff, and driving process improvements that reduce defects and ensure product integrity. I pursue continuous improvement and practical solutions that align quality with operational goals.
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Work history, roles, and key accomplishments
Catalent
Jun 2022 - Present (3 years 5 months)
Lead batch record review and approval ensuring cGMP and regulatory compliance (ISO 9001, ISO 13485, AS9100, 21 CFR) and managed internal/external audits to drive continuous quality improvements.
Merck
Jan 2020 - Feb 2022 (2 years 1 month)
Served as SME for deviation management, conducted root cause analysis using Lean/Six Sigma, and supported cGMP biologics manufacturing and clinical trial documentation control.
Almac
Feb 2016 - Jan 2020 (3 years 11 months)
Performed incoming/outgoing inspections, managed non-conformances and documentation, and recommended process improvements to reduce defects and ensure product conformance.
Ambler Fireplace & Patio
May 2005 - Feb 2016 (10 years 9 months)
Developed and executed sales strategies, led and trained sales teams, and managed operations to achieve average weekly sales of approximately $55,000.
Degrees, certifications, and relevant coursework
Bachelor of Business Management, Management Information Systems
Completed a Bachelor of Business Management with a focus in Management Information Systems and a minor in Biomedical Sciences.
Software and tools used professionally
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