Kara Nelson Email & Phone Number

United States

North Carolina, United States

Manage the Internal Audit Program and the Layered Process Audit Program. Document control, document management, workflows, version control and collaborations. Conduct process owner training. Facilitate QMS configuration management. Collaborator in rapid improvement events. Internal Quality Audit Program collaborator. Training & Development collaborator. Train internal auditors. Conduct internal process and product audits. Identify nonconformities and develop corrective action plans. Identify root causes and continuous improvement opportunities. Implement corrective actions, evaluate corrective action results, and record results. Served as project management lead to identify targets for continuous improvement within the Quality Department.

United States

Manages Quality Management Systems (QMS) and document reviews for parent company and three Ontic owned companies. Technical writing and editing. Develop Procedure Requirements, Work Instructions, Training Material and Forms. Document control, document management, workflows, version control and collaborations. Conduct process owner training. Facilitate QMS configuration management. Collaborator in rapid improvement events. Internal Quality Audit Program collaborator. Training & Development collaborator. Train internal auditors. Develop Quality onboarding material for training. Member of Audit Review Board. Conduct internal process and product audits. Identify nonconformities and develop corrective action plans. Identify root causes and continuous improvement opportunities. Implement corrective actions, evaluate corrective action results, and record results. Serves as the Quality Compliance Lead back-up. Facilitate Quality Team Meetings. Served as project management lead to identify targets for continuous improvement within the Quality Department.

Roxboro, North Carolina, United States

• Report directly to the Quality Assurance Manager and Site Compliance Manager. • Provide support to the Manufacturing Engineers and the Quality Engineers. • Manage and track Process Change Requests (PCRs) • Document Change Requests (DCRs) for the engineers. • Approve, process, and track high volumes of supplier Invoices. • Assist with Environmental Health & Safety tasks and responsibilities

Raleigh-Durham, North Carolina Area

•Managed site data for projects and team activities for various phases of industrial trials, including but not limited to, study start-up, maintenance, and close-out. •Collaborated with study team to resolve data, site, and project management issues. •Managed trial documentation; verified, collected, tracked, disseminated, and processed with accuracy in the Clinical Trials Management System (CTMS) and the Trial Master File (TMF-SharePoint), while maintaining compliance with the trial’s DEG, SOPs, ICH-GCP. •Strong skill set in auditing and reconciling TMF and CTMS critical issues.

Durham, Nc

•Assistant to Dr. Edward C. Suarez, Director of Clinical Research Unit (CRU) and the Vice-Chair for Research Administration, Department Psychiatry and Behavioral Science. •Collaborated with the Research Practice Manager to implement training for staff members, new-hires, and overall institutional compliance. •Percentage of effort split between Duke CRU and Duke CNSCR.

Durham, Nc

•Managed and maintained study specific protocols and regulatory documentation for active studies and studies in data analysis status for the central office and three satellite offices. •Managed data for sites, projects, and team activities for various phases of industrial trials, including but not limited to, Study Start-up, Maintenance and Close-out. •Prepared and submitted study related documentation to the Duke Institutional Review Board (IRB). •Percentage of effort split between Duke CNSCR and Duke CRU.

Durham, Nc

•Assistant to Medical Director, EMS Director, Education Department Administrators and Financial Administrator. •Certified Child Passenger Safety Technician from and managed a permanent fitting station for child passenger safety inspections. •Member of Quality Assurance Committee and EMS Advisory Council. •Maintained and tracked continuing education records and credentials. •Researched and compiled data for medical and trauma statistical reports and budget deadlines. •Managed logistics for onboarding employees including interviewing applicants, background checks, and verifying references. •Managed logistics for Applicant Assessment Centers and reported outcome of assessments. •Generated payroll.

Certification, Business Management, General

High School Diploma