Dwayne Howell

About Dwayne Howell

Contact Info: d••••••••@gmail.comDetailed, well-organized, and results-oriented GxP Computerized System Validation (CSV) QA & Regulatory Compliance professional with proven CSV system auditing skills, along with strong interpersonal and written communication skills. Highly effective in finding compliance gaps while handling several complex projects simultaneously. Demonstrated ability to foster and maintain strong customer relationships by being diplomatic and tactful at all levels. Skilled in developing and enforcing computerized systems Quality and Validation policies and practices.Specialties: • Computerized System Validation (CSV) and QA Validation (Review/Approval of Validation Deliverables/Approaches)• Computerized System Internal/External Audit Planning / Execution / Reporting expertise• Global CSV Policy/SOP Writing/Remediation• Risk Assessments (ERES, High Level, Functional, Impact)• 21 CFR Part 11 Assessment, Remediation, and Interpretation expertise• GAMP 5 Expertise• IT Infrastructure Compliance• Data Integrity Program Management (Awareness, Training, Governance, Remediation)

Experience

1. Senior Qa Rc Auditor

   Duke Clinical Research Institute

   Dec 2023 — Present · Durham, NC, US

   Primary Responsibilities and Tasks- Auditing (Lead, Support, or Host: Internal / Vendor / Site / Sponsor / Regulatory Inspections)- Quality Management Activities (Risk Management & Quality Incident Management)- Quality System Documents (Process Improvements, Lean, QbD, Lead Quality Policy/Document creation)- Consulting (Provide Regulatory Compliance guidance, Quality Agreement creation, Assist with Planned Deviations)- Training (Stay current with regulatory, quality, and industry trends related to GxP; mainly GCP, mentor other QA Auditors, consultants and staff within Quality Management)

Education

• North Carolina Central University

  BS, Mathematics

• Wake Technical Community College

  AAS, Electronics Engineering Technology

• Lumberton Senior High School

  Diploma

Skills

• Validation
• Vendor Audit
• Quality Management
• Pharmaceutical Industry
• Sop
• Fda
• 21 Cfr Part 11
• QA Validation
• Change Control
• Data Integrity
• Gcp
• Lotus Notes
• IT Infrastructure
• Computerized System Validation
• Gap Assessment & Remediation
• Sdlc
• Gxp
• Trackwise
• Sharepoint
• Testing
• Auditing
• Gamp
• Computer System Validation
• Sop Development
• Internal Audit
• Quality Assurance
• Quality Control
• Gmp
• Outlook
• Biotechnology
• Gxp Compliance
• Risk Assessment
• Clinical Trials
• Clinical Research
• Capa
• Global Regulatory Compliance