Qualifications:
Background: ⢠BS or MS degree in arts or sciencesĀ
⢠4+ years of technical writing experienceĀ
⢠Experience in change managementĀ
⢠Experience in medical, pharmaceutical, or other FDA regulated environmentĀ
⢠Understanding of CAPA and Quality processĀ
⢠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.Ā
⢠Knowledge of computer hardware and software, including Microsoft Office, Visio, Adobe Acrobat applications.Ā
⢠Communicating effectively in writing as appropriate to the audience.Ā
⢠Strong prioritization and multitasking skills. Managing one's own time and the time of others.Ā
Responsibilities:Ā
⢠Manage the documentation, change order, and change control processesĀ
⢠Experience with computer based change management software. Write change plans, document change ordersĀ
⢠Maintain records and files of work and revisionsĀ
⢠Develop SOPs and associated technical documentation as requiredĀ
⢠Interview and build relationships with SMEs in cross functional groups, including walking down a process to insure completeness and verify correctnessĀ
⢠Edit, standardize, or make changes to material prepared by SMEs or other Company personnelĀ
⢠Manage new documentation and revised documentation through lifecycle and document management systemĀ
⢠Help with investigations, non-conformances and CAPA processĀ
⢠Confer with customer representatives, vendors, regulatory personnel, or others to establish technical specificationsĀ
⢠Review established documentation and recommend revisions or changes in scope, format, and contentĀ
⢠Spend time with SMEs observing production, developmental, and experimental activities to determine operating procedure and detail.Ā
⢠Develop specific goals and plans to prioritize, organize, and accomplish your work.
Integrated Resources INC
https://careers.smartrecruiters.com/IntegratedResourcesINC