Writes and edits complex technical documentation, including user manuals, job aids, installation instructions, technical instructions/bulletins, and other technical publications from document plans and style guides. Develops on-line help screens for company products. Researches technical and engineering information, including drawings, design and test specifications, product prototypes, and interviews with subject matter experts. Completes all phases of document development cycle, including project scope and requirements, documentation design, etc. May develop, recommend and implement technical documentation process and policy changes.
The Technical Writer will be responsible for pre-identified change projects. This will include change documentation, detail analysis of the changes, gathering of any necessary information, drafting, editing, coordinating with production area leads and area manager, and implementing complex technical production, testing, process, and change documentations. The focus of the documentations is in the areas of reagents and calibrators. These reagents and calibrators impact the Dimension, Vista, Stratus CS and Atellica platforms at the site. The efforts are categorized into projects leading to quality improvements and production systems implementation.
Functions and responsibilities include:
- Learn the Quality Change Process required in the Operations area.
- Follow the Quality Change Process to implement various changes categorized by projects.
- Plan, author, document, and execute the projects.
- Formatting, writing and editing of complex technical documentation by following templates
- Develops, recommends and implements technical documentation changes to meet regulatory quality requirements and SAP based manufacturing system needs.
- Strong background with documented evidence of having worked in technical writing at the industry level.
- Understand the basics of Chemistry and Biology.
- Knowledge of FDA regulated environment.
- Familiar with GMP, GLP and GDP processes.
- Knowledge or familiarity with SAP production system is a plus.
- Familiar with basic laboratory techniques used in chemistry labs is a plus.
- Strong computer skills in the knowledge of Microsoft Word and Excel
- Strong communication and interpersonal skills.
- Must be able to work independently and be able to multi-task and prioritize daily work.
- Identifies problems as they occur and takes appropriate steps to solve them.
A two year degree and 5 years of experience.