
Cqa Erika Jones Smith Asq
Extensive background and experience in Pharmaceutical and CRO Quality Assurance . Risk and Compliance experience. Expertise consists of... | Durham, North Carolina, United States
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Cqa Erika Jones Smith Asq’s Emails sm****@wy****.com
Cqa Erika Jones Smith Asq’s Phone Numbers No phone number available.
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Cqa Erika Jones Smith Asq’s Location Durham, North Carolina, United States
Cqa Erika Jones Smith Asq’s Expertise Extensive background and experience in Pharmaceutical and CRO Quality Assurance . Risk and Compliance experience. Expertise consists of Computer System Validation (CSV) as an Independent Quality Reviewer and consultant, strong knowledge of software development life cycle (SDLC), GAMP 5 training, ICH guidelines, 21 CFR Part 11 regulations, ISO 27001 security standards. Strong understanding of security policies and practices, and data privacy. Knowledge of best practices/standards: GAMP 5, NIST, ISO 27001. Led IT Auditor, Led Contact for RFI/RFP. Leadership Training Classes, TrackWise Database, Livelink Database, Six Sigma Training, Standard Operations Procedures Writing Training, Project Management Training, EMR Records System, Part 11 21 CFR Computer Validation Systems Subject Matter Expert. Member of ASQ and ISPE and ISACA. Specialties: Medical Terminology, Medical Transcription experience, Quality Assurance experience, Aseptic Quality Operations Expert, Auditing Specialist. GCP and GxP experience. ASQ-Certified Quality Auditor. Working towards ISACA CISA certification Q4 2018
Cqa Erika Jones Smith Asq’s Current Industry Fortrea
Cqa
Erika Jones Smith Asq’s Prior Industry
Central Carolina Hospital
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Waste Mangement
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Belks Department Store
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Wyeth
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Pine Ridgesanford Sandhills Emergency
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Almac Clinicals
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Almac Clinical Services
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Eisai
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Inc Research
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Syneos Health
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Iqvia
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Labcorp Drug Development
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Fortrea
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Work Experience

Fortrea
Sr Manager, IT Quality and Compliance, Audit Support
Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time) — Present
Labcorp Drug Development
IT Quality Manager
Mon Apr 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Dec 01 2023 00:00:00 GMT+0000 (Coordinated Universal Time)
Iqvia
Sr IT QA Consultant
Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time) — Fri Mar 01 2019 00:00:00 GMT+0000 (Coordinated Universal Time)
Syneos Health
Sr IT Analyst
Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Dec 01 2018 00:00:00 GMT+0000 (Coordinated Universal Time)
Inc Research
IT QA Specialist II
Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jul 01 2017 00:00:00 GMT+0000 (Coordinated Universal Time)
Eisai
Sr. Parentenal Operations Support Specialist
Sun Jul 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Almac Clinicals
Quality Assurance Auditor
Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jul 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Almac Clinical Services
Experienced Quality Assuance Auditor/Specialist
Fri Jan 01 2010 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Jul 01 2012 00:00:00 GMT+0000 (Coordinated Universal Time)
Pine Ridgesanford Sandhills Emergency
Office Coordinator/Registration Specialist-Part Time
Tue Jan 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jul 01 2013 00:00:00 GMT+0000 (Coordinated Universal Time)
Wyeth
Quality Assurance Coordinator II
Mon Apr 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Nov 01 2008 00:00:00 GMT+0000 (Coordinated Universal Time)
Belks Department Store
Beauty Advisor/Sales
Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time) — Sun Sep 01 2002 00:00:00 GMT+0000 (Coordinated Universal Time)
Waste Mangement
Credit and Collections Specialist
Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time) — Mon Jan 01 2001 00:00:00 GMT+0000 (Coordinated Universal Time)
Central Carolina Hospital
Quality Assurance Analyst and Trainer
Tue Aug 01 1995 00:00:00 GMT+0000 (Coordinated Universal Time) — Sat Jan 01 2000 00:00:00 GMT+0000 (Coordinated Universal Time)