Operations & Quality Improvement Coordinator

Sharp Packaging Solutions, part of UDG Healthcare plc; Conshohocken (Montgomery County); On-site; USD 52,000 - 70,000; Full time

Job summary

Sharp Packaging Solutions, part of UDG Healthcare plc, seeks an Operations Coordinator to drive CAPA, Events/Deviations, and documentation accuracy. You will collaborate with Project Managers, Account Managers, and the Documentation Department, host plant tours, and support continuous improvement on the packaging floor.

The role emphasizes root-cause analysis, data review, and timely escalation of production issues while upholding safety and quality standards across operations.

Qualifications

• To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
• Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

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, seeks an Operations Coordinator to drive CAPA, Events/Deviations, and documentation accuracy. You will collaborate with Project Managers, Account Managers, and the Documentation Department, host plant tours, and support continuous improvement on the packaging floor.

The role emphasizes root-cause analysis, data review, and timely escalation of production issues while upholding safety and quality standards across operations.