Operations Coordinator 3rd Shift

Sharp Corporation; Allentown (Lehigh County); On-site; USD 55,000 - 75,000; Full time

Job summary

Sharp Packaging Services in Allentown, PA seeks an Operations Coordinator to drive documentation control and CAPA for events and deviations. You will coordinate with Project Managers, Account Managers and the Documentation Department, participate in customer visits and host plant tours to ensure timely document release for packaging operations.

Responsibilities include root cause analysis, CAPA closure, weekly tracking of open events, data analysis, SOP/WRKIs updates, and continuous improvement

Qualifications

• Experience coordinating documentation and CAPA in a manufacturing environment.
• Ability to collaborate with cross‑functional teams and customers.

Responsibilities

• Investigate, facilitate and assist in root cause analysis, problem solving and CAPA for Events and Deviations.
• Ensure closure and CAPA implementation for Events and Deviations.
• Maintain system timelines for Events and Deviations per SOPs.
• Perform corrective/preventive actions related to Event and Deviation reports.
• Communicate with internal/external customers to capture all information related to Events and Deviations.
• Track and report open Events and Deviations weekly.
• Analyze data and categorize root causes; report quarterly to upper management.
• Interface with Project Managers, Account Managers and Documentation Department to resolve document release issues.
• Assist in creating/reviewing documentation requirements and Storyboards as an Operations Representative.
• Observe packaging operations and recommend improvements to production methods and equipment performance.
• Formulate/review SOPs/WRKIs to improve processes and reduce defects.
• Suggest changes to working conditions and equipment use to increase efficiency and quality compliance.
• Support continuous improvement initiatives to motivate the work crew to meet goals.
• Represent Operations in internal/external meetings, audits and site visits.

Job description

Job Description SUMMARY:

Responsibilities include initiating Events and Deviations for the Operations Department and COE where applicable, assisting in the creation/review of documentation requirements for new and ongoing projects. Responsible for ongoing contact with Project Managers, Account Managers, and the Documentation Department regarding issues related to documentation. Will participate in customer visits and host plant tours.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• The following is a list of minimum responsibilities related to the Operations Coordinator position.
• Other duties may also be assigned.
• 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.

QUALIFICATIONS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

SUPERVISORY RESPONSIBILITIES:

Direct reports if any and the level of supervision.

PREFERRED / REQUIRED EDUCATION and/or EXPERIENCE:

Based on requirements that are job-related and consistent with business necessity.

PHYSICAL DEMANDS:

The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

WORK ENVIRONMENT:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

DISCLAIMER:

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned at any time with or without notice.

Sharp Packaging Services works across the world to create unique commercial and clinical packaging solutions for the pharmaceutical and biotechnology industry. We are made up of two dynamic international divisions, Sharp Packaging Solutions and Sharp Clinical Services. Together our 1,600 strong team works from state-of-the-art facilities in the United States, United Kingdom, Belgium and the Netherlands. We've built an exceptional global reputation for the design, serialisation and production of innovative, cost-effective compliance packaging for even the most complex products. Our extensive range includes blister packs, bottles, pouches and stick packs, but our expertise goes far beyond, enabling us to support your product through every stage of design, development, manufacture and delivery. Our clinical services division is one of the world’s leading providers of innovative clinical supply chain services, with a talented and highly experienced team that can handle every aspect of your supply chain. Our work spans everything from drug development and manufacturing to clinical supplies packaging, labelling, distribution, Qualified Person auditing and comparator sourcing.