Lisa Hinshaw Email & Phone Number

Lexington, NC, US

Lexington, NC, US

Internal Red Nucleus Quality Assurance Representative- Provide QA oversight to Red Nucleus QMS, product validation and change controls, SOP alignment and revision.- Ensure SOP training is performed/documented; harmonize corporate policies/procedures with regulatory compliance.- Support client audits and Vendor Qualification activities; conduct internal.

Winston-Salem, North Carolina

Comprehensive management of Quality Systems, including quality control, document control, change control, CAPA, SCAR and product conformance. Supervise testing and release for approved raw materials and finished products for distribution. Contribute to trend analysis, Key Performance Metrics, Lean Management, training, and continuous quality/process.

Greensboro/Winston-Salem, North Carolina Area

Quality Program Manager for clinical research industry. Compile and submit regulatory proposals (IND/PIND) for Phase I/II clinical trials, coordinate GLP/GMP facility operations, administer the Quality Assurance and Quality Management System for ISO 7 & 8 cleanroom environment. Ability to manage the program/project lifecycle and ensure timely goal.

Winston-Salem, NC

Manage the planning, implementation, and evaluation of clinical research involving multiple clinical trials and study sites. Partner with principal investigators, faculty and scientists to develop and deploy schedules that met sponsor and clinical reporting requirements. Manage the preparation, submission and follow up of all IND/PIND proposals to FDA.

Study Coordinator for the National Lung Screening Trial and other American College of Radiology Imaging Network (ACRIN) clinical research protocols.

Managed dietary program for residents of The Children's Home and students of Kingswood School.

Master Of Public Health (Mph)

Bachelor Of Science (B.S.), Public Health Nutrition