Brian Bennett Email & Phone Number

Durham, NC, US

Apex, NC, US

As Quality Systems Team Leader I’m responsible for supervising the Quality Team at the Durham Site and for ensuring that the laboratory achieves compliance with business and regulatory requirements in a timely manner. I’m also responsible for supervising and supporting Design Control activities ensuring product files are kept up to date and risk management.

As Quality System Specialist II I’m responsible for compiling and executing validation activities that ensure equipment (non-computerized and computerized) and that the laboratory and achieve compliance with business and regulatory requirements in a timely manner and to ensure that the validated status is maintained throughout the Operational and product.

Raleigh, NC, US

• Assist in developing quality assurance policies and procedures.
• Assist in development and implementation of laboratory changes and process improvements.
• Identify and investigate inconsistencies in laboratory processes. (Write Non-Conformance Reports and Corrective Actions/Preventative Actions Reports)
• Analyze QC data in order to identify trends in data and respond to the fluctuations in the laboratory.
• Ensure the calibration and maintenance of laboratory equipment through monitoring.
• Assist in Proficiency Testing, Validation Programs, Split Specimen Analysis.

• Evaluate current processes and recommend improvements with the goals of increased efficiency, improved product/service quality, and overall compliance.
• Perform analysis of workflow and recommend quality improvements.
• Setup and perform stability studies and review results with management.
• Setup validations for GC/MS instrument.
• Manage all paperwork for validations and studies preformed.
• Resolve all problems related to quality assurance and operations.

• Responsible for the extraction and derivatization of lab samples.
• Collect all aliquoted samples, along with appropriate calibrators, controls,labeled columns, tubes and vials for each GC/MS assay.
• Follow Standard Operating Procedures (SOP) for extraction and derivatization.
• Extract and derivative samples, calibrators and controls.
• Place extracted samples into ALS vial, and into GC/MS auto sampler.
• Prepare reagents and buffers, according to SOP.