Technical Writer III

Qualifications:

Background: • BS or MS degree in arts or sciences 

• 4+ years of technical writing experience 

• Experience in change management 

• Experience in medical, pharmaceutical, or other FDA regulated environment 

• Understanding of CAPA and Quality process 

• Strong knowledge of the English Language -- Knowledge of the structure and content of the English language including the meaning and spelling of words, rules of composition, and grammar. 

• Knowledge of computer hardware and software, including Microsoft Office, Visio, Adobe Acrobat applications. 

• Communicating effectively in writing as appropriate to the audience. 

• Strong prioritization and multitasking skills. Managing one's own time and the time of others. 

Responsibilities: 

• Manage the documentation, change order, and change control processes 

• Experience with computer based change management software. Write change plans, document change orders 

• Maintain records and files of work and revisions 

• Develop SOPs and associated technical documentation as required 

• Interview and build relationships with SMEs in cross functional groups, including walking down a process to insure completeness and verify correctness 

• Edit, standardize, or make changes to material prepared by SMEs or other Company personnel 

• Manage new documentation and revised documentation through lifecycle and document management system 

• Help with investigations, non-conformances and CAPA process 

• Confer with customer representatives, vendors, regulatory personnel, or others to establish technical specifications 

• Review established documentation and recommend revisions or changes in scope, format, and content 

• Spend time with SMEs observing production, developmental, and experimental activities to determine operating procedure and detail. 

• Develop specific goals and plans to prioritize, organize, and accomplish your work.