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Documentation Specialist II

Bayside Solutions South San Francisco ,CA
  • Expired: over a month ago. Applications are no longer accepted.
Job Description
  • Provide documentation and logistics support for a variety of activities working in an IMDRF/ISO regulated environment.
  • Collaborate with Compliance & Strategy and Architecture & Design teams to research, plan, write, edit, and maintain technical documentation
  • In charge of metadata review and workflow initiation in an electronic documentation management system, adhering to specific FDA, EMA, IMDRF requirements for documentation.
  • Consult with engineering, quality assurance, technical support, and product management to update existing documentation and write new platform and product documentation
  • Entrusted to initiate, oversee and give guidance on Design Change Requests using high-level access Quality Management software to improve platform and product quality, achieve regulatory compliance and reduce risk
  • Manage highly confidential documents in hard copy format as well as log sheets to maintain traceability, prevent misuse and help with prevention/response to CAPAs.
  • Managed content development process by coordinating with engineering team to track product changes and schedules and communicating changes
  • Maintain a comprehensive library of technical terminology and documentation
  • Manage updates and revisions to technical literature
  • Edited style guide for consistency

Summary of Qualifications:

  • Bachelor’s Degree in Biochemistry, Biotechnology or related field
  • Proven experience working in a technical writing position
  • Excellent written and verbal communication skills
  • Proficiency in MS Office
  • Strong attention to detail
  • Able to write in explanatory and procedural styles for multiple audiences
  • Skilled at prioritization and multitasking


Bayside Solutions


South San Francisco, CA
94080 USA