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.
