Sheila Bart
Qa Manager at Altasciences
Based in Kansas City, United States
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Seniority
Manager
Department
Information Technology
Location
Kansas City
Industry
Research Services
Company size
1.9K
Contact information
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s•••••••@altasciences.com
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Background
About Sheila Bart
Quality is my passion. I am known as a highly experienced Quality Assurance leader with 15+ years of experience in regulated environments. I have extensive regulatory knowledge and I am committed to ensuring compliance within your organization. During my career I have successfully facilitated and/or supported 100+ client audits and multiple regulatory inspections, assisted in developing and implementing a Bioanalytical Laboratory including a new CMC manufacturing facility and built a strong effective team while fostering an environment of continuous development and learning. My skills include but are not limited to: • Define and Implement QA Program • Release Investigational Products • Resource, Lead, and Support Internal & External Audits • Conduct Study Audits, Process Audits, Self-Inspections & Vendor Audits • Review validation documentation • Develop and streamline key QA processes • Implement risk-based audit approaches • Consult and collaborate on technical & quality related issues Regulatory Experience: GMP, GLP, GCP, ISO, and CAP / CLIA. Mobile No.+1 402-650-0013 bartsheila@outlook.com
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