Robert Worrell, Rqap-Glp Email & Phone Number

Greensboro, Nc, Us

Greensboro, Nc

- Oversee all Quality (QA/QC) issues within the company.- Supervise the activities of other individuals who may be assigned to perform quality duties.- Maintain company SOPs, including all historical documents.- Maintain all quality records and company facility records, including all historical documents.- Make recommendations to management regarding all quality functions which may improve work flow, efficiency, work quality, personnel training, and any other company operations that contribute to company quality programs.- Conduct appropriate training for employees including documentation requirements, cGCP, cGLP, cGMP, EPA and FDA compliance programs.- Conduct periodic audits of internal quality procedures to ensure compliance to company SOPs.- Maintain audit files for all CROs, manufacturers, analytical labs, etc. that contribute to the overall company quality and acceptable risk management.- Lead/participate in outside agency audits and address any adverse findings.- Maintain a current awareness of current regulatory changes/updates, through meeting attendance, seminars, etc. Keep company personnel appraised of such changes and theri impact on PAH, partners, and CMOs.- Perform any other duties, as deemed necessary by company management that contribute to the overall company quality program.- Review study data, as necessary or as requested by Study Directors or other key study personnel.- Provide reports to Principals and their management, as required by the regulations.- The above work activities are not inclusive of all duties an individual in this position might be asked to perform either now or in the future.- Manage departmental and corporate controlled documents. Facilitate and manage the process for writing, review and maintenance of Quality Management Procedures.- Other activities are to be carried out as directed by company management.

Morrisville, Nc

• Provided oversight and direction for BRT, Inc. Good Laboratory Practice (GLP) Compliance• Hosted and responded to Sponsor Audits, including Remote audits• Monitored GLP studies and facilities to assure management that facilities, equipment, personnel, methods, practices, records, and controls are in compliance with GLP Regulations• Developed and implemented Quality Assurance Unit (QAU) procedures to ensure compliance• Conducted and documented audits and provide status reports• Maintained copies of Protocols • Made recommendations for correcting deficiencies and ensured proper documentation for deviations to protocols and/or Standard Operating Procedures (SOPs)• Provided QAU statement for study reports• Maintained QAU-related documents (QAU SOPs, Master Schedule)

Greensboro, Nc

- Planned and conducted external site verification and study audits.- Conducted training on guidelines and regulations.- Well-versed in Good Clinical and Laboratory Practices (GCP/GLP).- Knowledge of Good Manufacturing Practices (GMP).- Experienced in working with a Global mindset to accomplish common business goals.- Experience in supporting R&D function with Quality Assurance reviews and guidance.- Conducted and facilitated audit and local site CAPA resolutions.- Experience in approving release of shipping Investigational Products for use in study sites.- Gathered metrics and issued monthly reports stating compliance of vital business areas (Deviation/CAPA resolutions, Procedure reviews, Quality Module reviews, etc.).- Distributed minutes/PowerPoint presentations to management from monthly R&D site Quality Committee meetings.- Assisted/Led in preparing and directing multiple clinical research facilities through successful (No objectionable 483 findings) FDA inspections.- Supported sister facility in preparation for internal audit.- Served on the R&D Site Quality Committee for enhancement of streamlines and workflows.- Conducted Electronic Signature training as well as multiple GCP/GLP refresher quality training sessions in various locations.

Greensboro, Nc

- Responsible for monitoring studies by contacting Investigators, scheduling external study site visits, reviewing study records and preparing reports in compliance with FDA guidances/requirements.- Kept current on all animal health regulations regarding drug development.- Assisted with preparation of reports to verify accuracy with protocol requirements.- Participated in training Investigators for study preparation.- Responsible for ensuring proper storage and reconciliation of study Investigational Veterinary Product (IVP) and/or Placebo materials.

Greensboro, Nc

- Provided timely Customer Service to Veterinary clinics and Distributors for product ordering.- Utilized SAP for order entry when interacting with customers.- Interacted with internal Sales Representatives for general business needs.- Assisted Veterinary clinics with resolutions when reconciling credit inquiries.