Onsite Operations & Documentation Coordinator

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

Job summary

Sharp Clinical Services seeks an Operations Coordinator to support the Operations Department and COE. Responsibilities include initiating Events and Deviations, reviewing documentation needs for new and ongoing projects, and maintaining contact with Project Managers, Account Managers, and Documentation.

The role involves visiting customers, hosting plant tours, and working with cross-functional teams to investigate root causes, CAPA determinations, and process improvements to minimize defects.

Qualifications

• Investigate root cause analysis, problem solving and CAPA for Events and Deviations.
• Track and report all open Events and Deviations weekly.
• Interface with Project Managers, Account Managers and Documentation Department to resolve issues related to documentation.

Responsibilities

• Investigate root cause analysis, problem solving and CAPA determination for Events and Deviations.
• Ensure closure and CAPA implementation for Events and Deviations.
• Track and report all open Events and Deviations on a weekly basis.
• Categorize root causes for Events and Deviations and report to upper management quarterly.
• Assist in creation/review/approval of documentation requirements for new and ongoing projects as an Operations Representative.
• Observe packaging operations and recommend improvements to production methods and reduce defects.
• Formulate/review Sharp SOPs/WRKIs to improve methods and minimize defects.
• Represent the Operations Department in meetings and plant visits.

Job description

Sharp Clinical Services seeks an Operations Coordinator to support the Operations Department and COE. Responsibilities include initiating Events and Deviations, reviewing documentation needs for new and ongoing projects, and maintaining contact with Project Managers, Account Managers, and Documentation.

The role involves visiting customers, hosting plant tours, and working with cross-functional teams to investigate root causes, CAPA determinations, and process improvements to minimize defects.