Technical Writer

Technical Writer - Engineering

TECHNICAL WRITER Position Summary: As a member of the Project Firefly Team, the Technical Writer will write, edit and coordinate internal technical documentation, such as operations manuals, maintenance manuals and instruction sheets. The Technical Writer will be responsible for working independently on multiple projects, and will partner closely with team members from Production, Engineering, and Quality to develop effective, user-friendly documentation, adapting quickly to deadlines, new business processes and software. The ability to follow and adhere to FDA quality standards, product specifications and all safety standards is critical. Essential Functions: · Revises, edits, and formats existing documentation, including Standard Operating Procedures, Batch Records, training manuals, and other manufacturing related instructions for use as required. · Create, edit and format new documentation and other manuals as part of the process development. · Manages all aspects of the document development and production, including document draft reviews and formal approvals and documentation control procedures. · Ensures compliance of documentation with all applicable regulatory/QSR requirements and manages approval of materials through all reviewers. · Performs other duties and responsibilities as required. Minimum Requirements: · Associates Degree in Technical Communications, Instructional Design or related field. · 3+ years experience in the writing and production of documentation for pharmaceuticals preferred. · Effective organizational skills. · Excellent writing and verbal communication skills · Effective Project Management skills. · Ability to communicate technical information in a clear and concise manner to non-technical audience. · Information and document design skills. · Knowledge of regulatory requirements. Preferred: · Bachelor?s Degree · cGMP · Working knowledge of Metric Stream Organizational Relationships/Scope: The Technical Writer has responsibility for maximizing the effectiveness of technical communications. Key working relationships include, but are not limited to the following: · Manufacturing Managers, Production Management, and Engineering to insure the technical accuracy of labeling materials. · Regulatory Affairs and other reviewers ? interacts directly to insure compliance and documentation with all applicable regulations. · Internal and External Resources ? insures labeling development in a timely and cost-effective manner. Disclaimer: The above statements are intended to describe the general nature and level of work being performed by employees and assigned to this classification. They are not intended to be construed as an exhaustive list of responsibilities, duties and skills required of employees assigned to this position.