Biopharmaceutical Technical Writer

2 weeks ago

Marietta, Pennsylvania, United States The Accuro Group Full time
Job Summary

We are seeking a highly skilled Biopharmaceutical Technical Writer to join our team at The Accuro Group. As a key member of our organization, you will be responsible for creating, revising, and improving documents within our manufacturing department.

Key Responsibilities
  • Develop and maintain high-quality documents, including business processes, SOPs, batch records, checklists, and other controlled documents.
  • Collaborate with manufacturing groups and support departments to ensure accurate, compliant, and streamlined controlled documents.
  • Drive continuous improvement in the controlled document system and identify best practices to increase usability and practicality of documents.
  • Champion standardization of documents across manufacturing groups, including content, structure, and format.
  • Serve as a change coordinator for projects in the manufacturing department.
  • Partner with learning and development and manufacturing groups to ensure documents support accurate representation of operations and provide a foundation for education and competency.
  • Format and manage documents using established guidelines and document templates.
  • Evaluate GMP documentation change requests and ensure accurate information in revision history.
  • Manage CAPA tasks related to GMP documentation revisions and determine when GMP documentation duplications exist.
  • Support Lean/Six Sigma program to drive continuous improvement and embed a culture of operational excellence.
Requirements
  • Bachelor's degree in a relevant field.
  • Master's degree preferred.
  • Knowledge of cGMP, FDA, and other regulatory requirements and quality systems.
  • Working knowledge of SAP and MES eBR, with demonstrated ability to learn other facets of SAP and MES.
  • Proficient use of MS Office Suite, Visio, Arris, and digital imaging.
  • Practical experience in the biopharmaceutical industry, with a strong understanding of highly regulated safety and quality standards.

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