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Sharp Packaging Services

Global contract pharmaceutical manufacturing and packaging

Operations Coordinator

Validation, Compliance & Quality SystemsConfirmed live in the last 24 hours
Full-timeConshohocken, PA, USANo salary listedIn-person

About the Job

Responsibilities

  • Initiate Events and Deviations for the Operations Department and Center of Excellence where applicable.
  • Assist in creating and reviewing documentation requirements for new and ongoing projects.
  • Maintain ongoing contact with Project Managers, Account Managers, and the Documentation Department regarding documentation issues.
  • Participate in customer visits and host plant tours.
  • Investigate, facilitate, and assist in root cause analysis, problem solving, and corrective and preventive action determination for Events and Deviations.
  • Ensure successful closure and corrective and preventive action implementation for Events and Deviations.
  • Ensure system timelines are met for Events and Deviations according to Sharp’s standard operating procedures.
  • 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 is captured.
  • Track and report all open Events and Deviations weekly.
  • Categorize root causes for Events and Deviations, analyze data, and report findings to upper management quarterly.
  • Interpret company policies for workers and enforce safety regulations.
  • Interface with Project Managers, Account Managers, and the Documentation Department to resolve problems associated with the timely release of documents needed to run the packaging floor.
  • Assist in creating and reviewing or approving documentation requirements for new and ongoing projects as an Operations Representative.
  • Assist in creating and reviewing or approving Storyboards as an Operations Representative.
  • Observe packaging operations and process flow, and recommend measures to improve production methods, equipment performance, and processes to minimize defects.
  • Analyze production data.
  • Formulate and review Sharp standard operating procedures and work instructions to improve production methods and equipment performance and minimize defect occurrence.
  • Suggest changes in working conditions and equipment use to increase work-crew efficiency and support quality compliance.
  • Analyze and resolve work problems or assist workers in solving production-related issues.
  • Initiate or suggest continuous-improvement initiatives to motivate workers to achieve work goals.
  • Represent the Operations Department in formulating, reviewing, and approving internal documents, including change control records, master production records, standard operating procedures, work instructions, forms, rework, reinspection, and redress protocols.
  • Represent the Operations Department in internal and external meetings and teleconferences.
  • Represent the Operations Department during customer visits, business review meetings, and plant tours.
  • Represent the Operations Department in process Failure Mode and Effects Analyses.
  • Represent the Operations Department in associated corrective and preventive actions.
  • Represent the Operations Department in internal and external audits and audit responses.
  • Assist the Production Supervisors and Head of Operations as required.

About the Company

Sharp Packaging Services

Global contract pharmaceutical manufacturing and packaging

Sharp Packaging Services provides integrated pharmaceutical services globally, including clinical supply chain, contract manufacturing, packaging, and distribution for pharma and biotech clients, from sterile fill-finish to gene therapy packaging. It offers end-to-end solutions: manufacturing, packaging design, serialization for blisters, bottles, and specialty injectables, plus global distribution to move products from development to market. It differentiates itself by serving both clinical-trial and commercial production at scale with niche capabilities and ongoing investment in new technologies and facilities. Its goal is to help clients bring new drugs to market faster and more cost-effectively through integrated, specialized packaging, manufacturing, and distribution.

Company size
1,001-5,000
Company stage
Debt Financing
Total funding
$712.5M
Headquarters
Allentown, PA
Founded
1993

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