Josh Carter

About Josh Carter

I have recently accepted a position in the quality organization at Merck as an Associate Director. In this role, I have been managing the stability, incoming quality, and sterility assurance teams.Other roles include a Senior Engineering Specialist supporting sterility assurance objectives and projects and a Quality Assurance Specialist supporting the sterile supply of the pharmaceutical manufacturing site. I have also served as the Aseptic Compliance Supervisor where I managed and developed around 30 environmental cleaning specialists. The group played a big part in the Quality support function for aseptic manufacturing.I also previously held the position of a Quality Engineer. In this role, I drove towards continuous improvement within the aseptic manufacturing area by completing various projects. I have also taken a position at Hospira as a Remediation Engineer. This job is part of a rotational program, where I developed a variety of skills across a multitude of different areas within the facility itself. My first rotation was in Chemical Quality Remediation where I assisted with an assessment of in-process specifications, the creation of laboratory test worksheets, and performing and writing Chemical Quality investigations and developing CAPAs to help reduce non-conformities. My next rotation was working as a Remediation Engineering in the Biological Quality Laboratory. I have worked on a team to help install a continuous particulate monitoring system on the manufacturing lines. I have also utilized Lean/Six Sigma skills to help reduce waste and unused materials in the stockroom. I also assisted with updating standard operating procedures to ensure that quality systems are maintained and to help drive toward continuous improvement within the organization.

Experience

1. Associate Director, Quality

   Merck

   Jan 2024 — Present · Durham, NC, US

Education

• North Carolina State University

  B.S. Degree, Biomedical Engineering

  2008 — 2012

Skills

• Trackwise
• Biomedical Engineering
• Data Analysis
• Six Sigma
• Change Control
• Gmp
• Quality Assurance
• Iso 13485
• Windows
• Technical Writing
• Sop
• Fda
• Design Control
• Lean Manufacturing
• Laboratory
• Visio
• Mac Os
• Microsoft Office
• Biomaterials
• Kaizen
• Kepner-Tregoe
• Solidworks
• Minitab
• Matlab
• Medical Devices
• Capa