Kelly Services Technical Writer - Scientific in Boulder, Colorado

Technical Writer - Scientific - Salary negotiable (Full Time) TEMP POSITION

Duties:

  • Writes, edits, and reviews cGMP manufacturing documents, specifications, SOPs, and general work instructions. Interprets existing documentation to translate into new formatting and information requirements.

  • Maintains standardized language and documentation practices that allow for consistent execution of documents.

  • Support projects initiated by Manufacturing, Quality Assurance, Quality Control, Facilities, and Research and Development. Simplification of SOPs to remove redundancies across documents.

  • Completes document change requests within the current quality management system.

  • Edits documents written by others to verify accuracy, consistency, grammar, and format.

  • Collaborate with subject matter experts SMEs to improve existing documents Collect input from various company stakeholders to consolidate comments and collaboratively resolve conflicts.

  • Translates process maps or other process representations and apply them to appropriate documentation.

  • Ability to multi-task in a fast-moving environment.

  • Maintains tracking spreadsheets and timelines as needed to coordinate revisions.

Requirements

  • Bachelor's Degree writing, life science, or related field with 2+ years of relevant quality systems experience in the Biotech or pharmaceutical industry.

  • Knowledge of FDA Regulations Experience in working in a GXP environment with emphasis on GCP, GLP, GPV, and GMP. Exemplary Verbal and Written Communication Skills Proficiency using Microsoft Word, Excel and PowerPoint.

  • Experience working in a system for collaborative document development. Must be a self-starter and capable of working with minimal oversight. Technical writing certification a plus.

  • Knowledge of FDA Regulations Experience in working in a GXP environment with an emphasis on GCP, GLP, GPV, and GMP. Bachelor s Degree in Writing, Life Science, or related field Education degree and/or coursework /Certification Technical Writing Certification Skills Duties /Software Microsoft Word, Excel and PowerPoint Skills