Documentation Specialist

5 days ago


Round Lake, Illinois, United States Stefanini Group Full time
{"Job Title": "Documentation Specialist", "Job Description": "Job Summary

We are seeking a highly detail-oriented and organized Documentation Specialist to join our team at Stefanini Group. As a Documentation Specialist, you will be responsible for reviewing and ensuring the accuracy of manufacturing documentation, including batch records and GMP documents. Your attention to detail and ability to work independently will be essential in this role.

Key Responsibilities
  • Review and verify the accuracy of manufacturing documentation, including batch records and GMP documents.
  • Ensure compliance with cGMP, Company Policies, and local SOPs.
  • Support the manufacturing team in maintaining accurate and up-to-date documentation.
  • Initiate and close GME work orders as necessary.
  • Author Non-Conformance Records (NCRs) and Exceptions Investigations.
  • Author TCU documentation changes, including revisions, periodic reviews, and GAP assessments.
  • Use Maximo system to print department preventative maintenance work orders and assign tasks as necessary.
  • Use SYSTECH to review and approve counts for batches.
  • Initiate batch folders by performing necessary data entry.
  • Support GME cycle counting as needed.
Requirements
  • Associates degree or 3+ years of experience in a manufacturing environment and/or quality documentation.
  • Strong computer skills in MS Office Suite.
  • Knowledge of documentation systems and familiarity with batch/systems documentation preferred.
  • Strong attention to detail and ability to work independently.
  • Ability to communicate efficiently verbally and in writing with all levels of the organization.
  • Identify areas for continuous improvement.
  • Ability to adjust work hours and work overtime based on business needs.
  • Ability to lift 30 pounds.
  • Ability to pass a background check and provide proof of eligibility to work in the United States.
About Stefanini Group

Stefanini Group is a global provider of offshore, onshore, and nearshore outsourcing, IT digital consulting, systems integration, application, and strategic staffing services to Fortune 1000 enterprises around the world. Our presence is in countries like the Americas, Europe, Africa, and Asia, and more than four hundred clients across a broad spectrum of markets, including financial services, manufacturing, telecommunications, chemical services, technology, public sector, and utilities.

", "Pay Range": "$25.50"}

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