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.