2nd Shift Operations Coordinator — Process & Compliance

Sharp Clinical Services; Allentown (Lehigh County); On-site; USD 34,000 - 37,000; Full time

Job summary

Sharp Clinical Services is seeking an Operations Coordinator to initiate Events and Deviations for the Operations Department and COE, and to support documentation for new and ongoing projects. The role involves frequent interaction with Project Managers, Account Managers, and the Documentation Department, and may include customer visits and plant tours.

The position emphasizes root cause analysis, CAPA determination, and timely closure of issues, with a focus on improving production methods and

Responsibilities

• Investigate, facilitate and assist in root cause analysis, problem solving and CAPA determination for Events and Deviations.
• Ensure successful closure and CAPA implementation for Events and Deviations.
• Communicate with internal and external customers to ensure all applicable information related to Events and Deviations have been captured.
• Track and report all open Events and Deviations on a weekly basis.
• Interpret and enforce safety regulations and company policies with workers on site.
• Assist in the creation and review/approval of documentation requirements for new and ongoing projects.
• Observe packaging operations/process flow and suggest improvements to minimize defects.

Skills

Root cause analysis

CAPA

Documentation management

SOPs development

Process improvement

Problem solving

Job description

Sharp Clinical Services is seeking an Operations Coordinator to initiate Events and Deviations for the Operations Department and COE, and to support documentation for new and ongoing projects. The role involves frequent interaction with Project Managers, Account Managers, and the Documentation Department, and may include customer visits and plant tours.

The position emphasizes root cause analysis, CAPA determination, and timely closure of issues, with a focus on improving production methods and