Braxton Summers Email & Phone Number

United States

Review and approval of Change control initiation. Review and approve minor change controls.

Durham, North Carolina, United States

Batch Record reviewSOP revisionDeviation writing, review. Execution of CAPAs. Change Control

Raleigh-Durham, North Carolina Area

Lead and mentor direct reports ensuring responsibilities are competently performed. Ensure site is inspection ready at all times utilizing sound quality principles, self inspection learning and non conformity remediation. Prepare reports to site, area, and corporate quality management as to the state of quality and systems at the site. Oversee training of center staff.

Durham, Nc

Drive quality and yield improvements through the use of KPI’s in conjunction with techniques, such as mistake proofing, visual standard work, and value stream analysis. Focus on continuous improvement, collaborating with other departments to increase yield through quality improvement methodologies.• Hosted a PPTA audit resulting in a 3 year recertification.

Raleigh, Nc

Followed continuous improvement practices and participated in cross-functional teams, impacting production, increasing efficiency, solving problems, generating cost savings, and improving quality systems. • Ensured all quality standards and procedures were maintained including training and monitoring of new and existing employees in the processes and methods required to achieve business standards. • Reviewed analyses of activities, costs, operations, and forecast data to determine progress toward stated goals and objectives. • Identified and addressed technical and validation gaps in analytical methods while implementing improvements in analytical methods.

Raleigh-Durham, North Carolina Area

Participated in annual audit of QA group. Primary responsibility was to accurately process all forms of department documentation Handled majority of testing documentation and quality review of test run paperwork During review of test results, handled initiation of incident and error correction forsituations occurring outside of normal processing procedures

Raleigh-Durham, North Carolina Area

Ran site wide calibration program while performing testing duties Responsible for writing new procedures for equipment calibration and revising multipleprocedure Handled investigation/troubleshooting for instrument issues. Also equipment/instrumentmaintenance, calibrations.

Raleigh, Nc

Performed in-process testing and FDA regulated tests using nucleic acid testingtechnologies to screen blood plasma samples for HIV, hepatitis C, hepatitis B or parvovirus B19 Experience with robotic pipettors and high throughput testing