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Technical Writer Operations

Job Introduction

Assist with the company’s Remediation Consent Decree and CMC programme(s) to ensure the improvement initiatives are delivered on time. 

This Role supports Operations/Quality and reports to the Quality and Technical Operations Remediation Lead. 

Travel dependent on project requirements. 

6+ years of proven experience in writing technical documentation

Role Responsibility

  • Disseminate technical information in easy-to-understand language for a non-technical audience. 

  • Have technical accuracy in writing user documentation. 

  • Help other writers in creating documentation. 

  • Ability to take existing and potential content and improve it. 

  • Communicate complex ideas in a concise manner. 

  • Prepare deviation report. 

The Ideal Candidate

  • Technical Writing experience  

  • Working knowledge and experience in GMP environments and QMS Systems 

  • Detail Oriented  

  • Able to work under pressure and able to work to defined timelines.

  • Desired experiences in project management, change management, quality systems, quality assurance, validation, and manufacturing operations. 

  • Support and Mentor current QMS stakeholders through internal sharing and knowledge transfer. 


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