Kelly Services Technical Writer - Scientific in Boulder, Colorado
Technical Writer - Scientific - Salary negotiable (Full Time) TEMP POSITION
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.
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