Ernestine Harte
Director, Quality Assurance at Faraday Pharmaceuticals, Inc.
- Role
- Director, Quality Assurance at Faraday Pharmaceuticals, Inc
- Location
- Raleigh-Durham-Chapel Hill, NC, US
- LinkedIn followers
- 500 followers
About Ernestine Harte
Proactive Quality Assurance and compliance professional with extensive experience in the pharmaceutical and biotechnology industries (solid dose/parenteral) with specific focus on quality system compliance, quality management systems, computer system validation, quality systems implementation, vendor/supplier management, clinical start-up and GxP regulatory compliance activities. Key strengths include: Quality Audits, Good Manufacturing Practice, Good Laboratory Practice, Good Clinical Practice, Part 11 Compliance, Supplier Management, Data Integrity, Corrective and Preventive Action (CAPA), Product Quality, Computer System Validation (Software Validation), Deviations, NCMR, OOS, Problem Solver, Change Control, Investigations, Complaint Management, Systems Implementation/Configuration, Standard Operating Procedures, Quality Metrics, Quality Systems Management, Document Management, Batch Release, Effective Communicator, Training, Lifecycle Management, Team Player / Collaborator. Computer Literate (Microsoft Office suite, Visio, Mind Map, Adobe Acrobat, Forms Creation, Captivate)
Experience
Director, Quality Assurance
May 2022 — Present · Seattle, WA, US
Education
East Carolina University
Master of Science Technology Systems (MSTS)
Saint Augustine’s University
B.S
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