Biopharmaceutical Technical Writer Specialist

3 weeks ago


Marietta, Pennsylvania, United States The Accuro Group Full time
Job Title: Biopharmaceutical Technical Writer

Join The Accuro Group as a Biopharmaceutical Technical Writer and contribute to the development of high-quality documents that support our manufacturing operations.

About the Role:

We are seeking a skilled Technical Writer to join our team. As a Biopharmaceutical Technical Writer, you will be responsible for creating, revising, and improving documents related to manufacturing processes, including business processes, SOPs, batch records, checklists, and more.

Key Responsibilities:
  • Author and revise documents to ensure accuracy, compliance, and usability.
  • Collaborate with manufacturing groups and support departments to ensure seamless communication and document control.
  • Drive continuous improvement in the controlled document system and identify best practices for document usability and practicality.
  • Champion standardization of documents across manufacturing groups, ensuring consistency in content, structure, and format.
  • Serve as a change coordinator for projects in the manufacturing department, ensuring timely and effective implementation of changes.
  • Partner with learning and development teams to ensure documents support accurate representation of operations and provide a foundation for education and competency.
  • Evaluate GMP documentation change requests, determine scope of change, and ensure accurate information in revision history.
  • Manage CAPA tasks related to GMP documentation revisions and determine when GMP documentation duplications exist, managing resolution and consolidation of affected documents.
  • Support Lean/Six Sigma program to drive continuous improvement and embed a culture of operational excellence in document usability and practicality.
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, given the highly regulated safety and quality standards.
What We Offer:

The Accuro Group offers a dynamic and challenging work environment, with opportunities for professional growth and development. As a Biopharmaceutical Technical Writer, you will be part of a team that values innovation, collaboration, and excellence.



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