Job Details

  • Title: Documentation Specialist
  • Code: RCI-02712
  • Location: Framingham Massachusetts (MA) 01701
  • Posted Date: 07/28/2020
  • Duration: 5 Months
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  Job Description

Track and review change control documentation. Assist with the editing of quality documents (Master Batch Records, SOPs, guidelines, etc.) to ensure compliance with regulator and internal quality requirements. Must be able to work quickly with a high degree of accuracy.

Must possess sound interpersonal and information gathering skills, be able to relate well to others at all levels throughout the organization and have the ability to work in a team environment, effectively interacting with others. Prepare and/or maintain documentation pertaining to programming, systems operation, and user documentation. Translate business specifications into user documentation. Plan, write, and maintain systems and user support documentation efforts; including online help screens.

Knowledgeable of commonly used concepts, practices, and procedures within a particular field. Rely on instructions and pre-established guidelines to perform the functions of the job.. 

Successful candidate will be supplied laptop and training on site. After training all work can be performed remotely.

Maximum of 8 hrs. a day and 40 hours a week is to be logged. Hours above 40 hours per week can only be performed with express approval of Sr. Dir of Biosurgery. Only hours training, working and formatting records as well as email communication time will be logged.

Training will be required on SOP's to describe Master Batch Records (MBR's) and governing SOP's. The SOP's describe the formatting required to make the MBR's compliant.

The MBR's will be checked out of the document management system and sent securely to the new hire. The new employee will then modify the records to the compliant state. The documents will then be send to the technical/quality group for review and further modification.