2nd Shift Operations & CAPA Coordinator

Sharp Packaging Solutions, part of UDG Healthcare plc; Allentown (Lehigh County); On-site; USD 60,000 - 90,000; Full time

Job summary

Sharp Packaging Solutions, part of UDG Healthcare plc, is seeking an Operations Coordinator in the United States for the Lehigh Valley area. The role focuses on initiating Events/Deviations, CAPA, and documenting project requirements while maintaining strong liaison with Project Managers, Account Managers, and the Documentation Department.

You will participate in customer visits, host plant tours, and drive continuous improvement across packaging operations.

Qualifications

• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.
• Based on requirements that are job-related and consistent with business necessity.

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.
• Ensure the system timelines are met for Events and Deviations per Sharp’s SOPs.
• Determine, facilitate and/or complete corrective and preventive action activities associated with Event and Deviation reports.
• 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.
• Categorize root causes for Events and Deviations, analyze data and report to upper management on a quarterly basis.
• Interprets company policies to workers and enforces safety regulations.
• Interface with Project Managers, Account Managers and Documentation Department to: Resolve problems associated with the timely release of documents needed to run the packaging floor.
• Assist in the creation and review/approval of documentation requirements for new and ongoing projects as an Operations Representative.
• Assist in the creation and review/approval of Storyboards as an Operations Representative.
• Observe packaging operations/process flow and recommend measures to improve production methods, equipment performance and process improvements to minimize defect occurrence.
• Analyze Production data.
• Formulate/review Sharp SOPs/WRKIs to improve production methods, equipment performance, and minimize defect occurrence.
• Suggest changes in working conditions and use of equipment to increase efficiency of work crew and support quality compliance.
• Analyze and resolve work problems or assist workers in solving production related issues/problems.
• Initiate or suggest continuous improvement initiates to motivate workers to achieve work goals.
• Represent the Operations Department in: Formulate, review and approve Internal Documents (CCRs/MPRs/SOPs/WRKIs/Forms/Rework/Reinspection/Redress Protocols); Internal and external meetings / teleconferences; Customer visits, business review meetings and host plant tours; pFMEAs; Any associated corrective/preventative actions; Internal and external Audits /Audit Responses.
• Assist the Production Supervisors and Head of Operations as required.

Job description

Sharp Packaging Solutions, part of UDG Healthcare plc, is seeking an Operations Coordinator in the United States for the Lehigh Valley area. The role focuses on initiating Events/Deviations, CAPA, and documenting project requirements while maintaining strong liaison with Project Managers, Account Managers, and the Documentation Department.

You will participate in customer visits, host plant tours, and drive continuous improvement across packaging operations.