Quality Assurance Auditors

Quality Assurance Auditors

Judith McDowall, Director

Barbara Randolph, Senior Quality Assurance Auditor

Sherry Fowler, Senior Quality Assurance Auditor

Presentations and Posters by BSI QA Staff are available here for download.

Professional Society Involvement

BSI Auditors are actively involved in the Society of Quality Assurance (SQA) including elected positions, committees, and specialty sections such as the Council on Professional Registration, the BioAnalytical Specialty Section, and the Animal Health Specialty Section. BSI is a Silver Supporter of SQA.

BSI Quality Assurance staff members maintain involvement with:

Experience and Qualifications

BSI's auditors have more than 25 years of experience in regulated industry quality assurance including auditing/inspecting GLP and GCP research within the FDA- and EPA-regulated industries. BSI's quality assurance auditors are Registered Quality Assurance Professionals in Good Laboratory Practice (RQAP-GLP). As a team, they possess scientific education and training in the following disciplines: biochemistry, biology, chemistry, genetics, medical technology, microbiology, and toxicology; and have more than 25 years of experience working in clinical or research laboratories.

Training and Continuing Education

BSI maintains a full complement of SOPs and current training records for all auditors. By attending external training events and providing internal refresher courses, BSI's auditors understand and maintain knowledge of current issues in quality assurance. The staff learns of regulatory agency opinions, and changes in regulations and guidance documents by subscribing to updates and conversing with others in the field. Auditors attend specialized client-, project-, or protocol-specific training modules as necessary. Records of client-specific training are maintained confidentially in "client specific" sections of each auditor's training file. Training files are updated as needed and are reviewed annually.