Operations Coordinator - First Shift
Sharp Services
Summary
At Sharp, being resourceful is a defining value, not just a buzzword. We adapt to changing circumstances; adjusting our plans when we need to. We think through how a project might play out so we can anticipate challenges while finding clever ways to solve problems. We're looking for resourceful, adaptable professionals who can navigate evolving circumstances.
Job description
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 formulating, reviewing and approving Internal Documents (CCRs/MPRs/SOPs/WRKIs/Forms/Rework/Reinspection/Redress Protocols).
- Represent the Operations Department in internal and external meetings / teleconferences.
- Represent the Operations Department in customer visits, business review meetings and host plant tours.
- Represent the Operations Department in pFMEAs.
- Represent the Operations Department in any associated corrective/preventative actions.
- Represent the Operations Department in 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.
Requirements
- Ability to investigate, facilitate and assist in root cause analysis, problem solving and CAPA determination for Events and Deviations
- Ability to ensure successful closure and CAPA implementation for Events and Deviations
- Ability to ensure system timelines are met for Events and Deviations per SOPs
- Ability to determine, facilitate and/or complete corrective and preventive action activities
- Ability to communicate with internal and external customers
- Ability to track and report open Events and Deviations
- Ability to categorize root causes, analyze data and report to upper management
- Ability to interpret company policies and enforce safety regulations
- Ability to interface with Project Managers, Account Managers and Documentation Department
- Ability to assist in creation and review/approval of documentation requirements
- Ability to observe packaging operations/process flow and recommend improvements
- Ability to analyze production data
- Ability to formulate/review SOPs/WRKIs
- Ability to suggest changes to increase efficiency and support quality compliance
- Ability to analyze and resolve work problems
- Ability to initiate or suggest continuous improvement initiatives
- Ability to represent Operations Department in various meetings and audits
- Ability to assist Production Supervisors and Head of Operations
Company overview
Sharp Services is a global leader in pharmaceutical contract development and manufacturing services with over 70 years of heritage. The company specializes in three core areas: sterile manufacturing for clinical use and small-scale commercial requirements, comprehensive clinical trial supply services from preclinical to commercial launch, and innovative commercial packaging solutions. With a workforce of over 2,500 employees across state-of-the-art GMP facilities in the United States, United Kingdom, Belgium, and the Netherlands, Sharp provides end-to-end support for pharmaceutical and biotechnology clients. Their expertise spans the entire drug development lifecycle, offering solutions that reduce risk, complexity, and timelines for clinical trials while ensuring regulatory compliance and quality standards. The company's recent $100 million investment in expanding its EU and US facilities demonstrates its commitment to enhancing capabilities and capacity to better serve partners worldwide.