Paxton Ebright

Manager, Group Quality System @Bachem

San Diego County, CA, US
EMAILS
p••••••••@bachem.com
MOBILE NUMBERS
+18•••••••43

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WORK HISTORY

Feb 2024 — Present

Manager, Group Quality System @Bachem

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Vista, CA, US

Ensure the Group Quality System US team is properly trained. Coach and mentor direct reports as needed to achieve organizational goals. • Oversee Quality System and Digital Quality, including enhancement and implementation of new software solutions • Assigns responsibilities, monitors projects and oversees team to ensure goals are met in a timely manor • Lead/support the harmonization of quality systems between two US sites and the European sites • Lead/support continuous improvement initiatives at two US locations and at global level • Support the system administration of the electronic QMS including new functionalities/workflow requests and QMS related incidents • Ensure select quality system elements e.g. Bachem’s eQMS are kept in a compliant state • QA-oversight of CSV activities at US sites • Lead/support the compilation of Quality System Management Review • Support customer audits and regulatory inspections

EDUCATION

1990 — 1994

UC Irvine

Bachelor of Science (B.S.), Biological Sciences

2017 — 2019

The George Washington University School of Medicine and Health Sciences

Master of Science - MS, Regulatory Affairs

1999 — 2002

San Diego State University

Master of Business Administration (M.B.A.), Business Administration and Management, General

SKILLS

Medical DevicesCapaStatisticsVerification and Validation (V&V)Lean ManufacturingSupplier QualityIso 14971FdaDesign ControlCorrective and Preventive Action (Capa)Six SigmaLife SciencesQuality ControlGmpManufacturingProject ManagementIso 13485Quality SystemV&VComplianceU.s. Food and Drug Administration (Fda)AuditingQuality AssuranceBiotechnologyValidation

ABOUT PAXTON EBRIGHT

I have over 20 years of experience in the medical diagnostic field, with a M.S. in Regulatory Affairs from GWU and a Six Sigma Green Belt certification from ASQ.My core competencies include quality assurance, quality control, technical operations, and auditing. I am adept at providing pragmatic solutions using strong technical skills and Six Sigma/Lean methodologies. I have led multiple Kaizen and process improvement initiatives, resulting in savings of work hours annually. I am passionate about staff development and continuous improvement, and I believe that the Quality Organization can be the driving force for innovation and growth.

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