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.