Technical Writer

Description

Must be onsite

Job Summary:

• The Technical Writer develops, designs and controls instructional and informational tools needed to assure safe, appropriate, and effective use of science and technology, intellectual property and manufactured products and services.
• This individual combines multimedia knowledge and strong communication skills with technical expertise to educate across the entire spectrum of user abilities, technical experience and visual and auditory capabilities.

Essential Duties and Responsibilities:

• Works closely with key personnel and participates in technical training to develop expert level understanding of assays, instrumentation, and software as it applies to documentation.
• Manages multiple user documentation projects at a time.
• Designs and implements work instructions, area guidelines, knowledge base topics, style guides/templates and departmental SOPS.
• Analyze current processes, identifying and evaluating options and suggesting changes with the intent of improving efficiency, or quality.
• Guides or performs the creation of new documentation and the review, revision and enhancement and approval of existing documentation.
• Identify and implement document changes to maintain consistency across product lines/processes.
• Performs and troubleshoots instrumentation, assays, software applications, etc. to develop and improve content.
• For INVs/CAPAs, conduct investigations using analytical skills and judgement, conferring with other writers and SMEs when appropriate, to determine root cause, and to recommend and implement changes.
• Uses discretion and judgement, including consideration of business priorities, to prioritize deliverables and manage “expedites.”
• Independently integrate SDS information into package inserts to comply with GHS standards.
• For inventoried items, prepare specs and work with procurement to ensure accuracy.
• Coordinates final production of documents w/ print vendors as required.
• As required, assign document change responsibilities, and provide training and assistance to EDMS users.
• Processes labeling project change orders in EDMS/Agile system.
• Works in conjunction with other departments where appropriate.
• Must follow all applicable FDA regulations and ISO requirements.

Qualifications:

Education

• Preferred Minimum Non-Technical Degree: College Degree

Experience

• Experience with PLM systems
• Experience with source controls such as Team Foundation Server and GitHub is beneficial.

Skills

• In depth knowledge of Technical Writing Theory and Practices, Design Theory
• Proficiency in Adobe FrameMaker, MadCap Flare, InDesign, Author-IT and MS Office applications
• Project and time management skills