Documentation Specialist/Technical Writer
Cranberry, PA. Posted 2 years ago
5 - 20 Years
Any Work Permit encouraged to apply
Responsible for creation and maintenance of System Validation documentation. Translates technical and/or complicated information into clear, concise documents appropriate for various purposes. Works with Development, Quality Assurance and Technical Support to produce required regulatory documents. Interviews subject matter experts and technical staff to collect information, prepare written text, and coordinate layout and material organization. Researches information such as drawings, design reports, equipment and test specifications to fill any gaps. Reviews, critiques, and edits documentation including design documents, programmer notes and system overviews. Coordinates and oversees system testing and documents test results. Must have strong organizational and project management skills and excellent writing and editing skills. Bachelor's Degree in Technical, Business Administration, or other related field. Or equivalent work experience. Typically has 3 to 5 years of regulatory requirements and system documentation. FDA electronic system validation knowledge and/or experience.
technical business administration test results system validation responsible for creation technical support system testing test specifications quality assurance gaps