Quality Assurance Experience

Quality Assurance Mastery

Is at the core of everything I do.

Quality Assurance Experience

Bonita’s Quality Assurance (QA) experience began in 2003 where she worked as a corporate Quality Assurance Specialist for a large Site Management Organization (SMO) that included serving on the company’s Standard Operating Procedure (SOP) Harmonization Committee, providing internal QA support and consultancy for 56 Investigative sites, and assisting non-compliant sites with the required corrective and preventative action plans to bring them back within compliance. In 2010, Bonita was the Quality and Regulatory Compliance Manager for another SMO specializing in Emergency Medicine research and was tasked with writing the site’s SOPs, providing training to new investigators, research nurses, study coordinators, research laboratory technicians, regulatory staff, and setting up a Quality Management System (QMS) in the academic setting. Between 2014 and 2020, Bonita obtained her GCP auditor’s certification and worked for both large and small Contract Research Organizations (CROs) holding positions of Contract GCP Auditor, Quality Assurance Manager, Principal Auditor, and Senior Auditor where she conducted numerous Routine and For Cause Investigative Site Audits, as well as Trial Master File and Clinical Study Report Audits.

QA Consulting Experience

From 2020 – 2023, Bonita has worked full time as a Senior GCP Auditor for a consulting firm that has allowed her to understand the consulting environment working with a variety of clients from large and small pharmaceutical and biotechnology companies and adapting to different processes, templates, and report writing guidelines.

As a result of her professionalism and high work standards, Bonita was one of the most requested billable auditors.

International GCP Auditing Experience

Bonita has had the opportunity to conduct Investigator Site Audits in Estonia, The Netherlands, Mexico, and Canada. She travels to the Baltics on a semi-regular basis and hopes to have the opportunity to conduct more international audits in the future.