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 audits and formulate remediation plans.- Actively engage on internal tasks such as process improvements, candidate interviews, and Red Paper reviews.Quality Assurance Manager for BioPharma client- Perform Vendor Qualification and Oversight through Audits and Management of SCARs, Quality Events and Deviations.- Administer Document Control and training activities through MasterControl to support a virtual business model.- Review Drug Substance and Drug Product Batch records; release lots as required with CoA/CoT.- Assist transition from clinical phase to commercialization, including IND and BLA submission preparation.GxP e-Learning Training Modules SME- Develop content for GCP Learning Journeys providing insight on guidelines, regulations, and processes required for compliance.- Outline and edit GCP course trainings utilizing a story board process to guide users through clinical trial initiation and execution.- Engage Quality Assurance principles to ensure training alignment with current best practices.

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 improvement initiatives. Identify, develop, and implement processes enabling company compliance with all applicable regulations both voluntary and compulsory, specifically the implementation of a Quality Management System compliant to ISO 13485; FDA 21 CFR Part 820, 810, and 811; ISO 9001; the EU and Health Canada for medical/pharmaceutical practices. Act as Quality liaison between organization and customers.

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 completion by facilitating collaboration between team members. Adept multi-tasking required with specific attention to details; excellent communication and interpersonal skills. Responsible for Clinical Data Management, Clinical Trial Management System (CTMS), Electronic Data Capture (EDC) and Personnel Management.

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; create and manage budgets, data collection and reporting; coordinate timelines and deliverables for pre-clinical and clinical trials. Cross-trained in GMP Quality Assurance role.

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