Brandon Blackhart Email & Phone Number

United States

I coordinated comprehensive Quality Assurance Auditing operations, demonstrating advanced application of SOPs and STPs across multiple departments and test types, in addition to familiarity with ISO and FDA regulations. I routinely coordinate review of GLP studies throughout testing, ensuring the study maintains compliance with established procedures and regulations. I frequently oversee audits of standard procedures in Master Control, as well as inspect logbooks and write QE's. Moreover, I collaborate with Section Leaders, Managers, Study Directors and Lab Analysts to perform facilitation, trend reviews and ensuring all data and reports are accurate. Key accomplishments include:• Successfully completing 10% of the organizations QA datapack reviews, in addition to 10% of team audits. • Demonstrating ability to quickly learn new procedures, implementing process changes as necessary.• Identified compliance issues in multiple departments and updated procedures to meet regulatory demands. • Mentor and train new employees.• Routinely contributing to key decisions increasing process quality.

United States

Throughout my tenure in this role, I contributed to department training and new instrument validation. I conducted numerous daily operations, operating a variety of technical instruments, including Gas Chromatography, Ultraviolet-Visible Spectroscopy, Centrifuge, and Hydrostatic Pressure. Engage in training, mentorship, and tech review. I regularly partnered with colleagues to complete studies in a timely manner, while upholding strict scientific standards. Additionally, I followed protocols and GLP standards to ensure data integrity. Significant contributions include:• Consistently assisting departments in meeting monthly revenue, utilization, and efficiency goals.• Increasing organizational effectiveness, becoming cross-trained to fillvacant roles across the organization.• Successfully written 4 STPs for Chemistry EO residual testing.• Showing a proven competency in more than 75% of testing completed in the section.

United States

Australia