Job Title: Manufacturing Technical Writer
Location: 1220 W. Morris Street, Indianapolis, IN 46285
Duration: 06 Months
Shift: M – F 8:00 AM to 5:00 PM
Responsibilities:
Support the manufacturing, quality assurance, engineering, and a variety of other departments by incorporating subject matter expert comments into well-constructed and easy-to-read approvable documents.
Edit/write a variety of technical articles, reports, manuals, flow charts, and other documentation for a wide range of uses, including GMP operations and validation activities.
Edit/create presentations, charts, diagrams, graphics, and research documentation.
Write test scripts. Assist data entry, report generation, accuracy checks, and tracking.
Assist in assembly of validation package documents for GMP libraries.
Qualifications:
Undergraduate/Bachelors Degree or Equivalent Work.
Laboratory: Willing to perform testing in a laboratory environment using automated laboratory equipment
Laboratory Equipment
Learning Agility
Manufacturing Process Validation
Microsoft Office: Word, Excel, PPT
Quality System Compliance
Quality Systems Regulation: Able to reference company standards to meet regulatory guidelines
Software Development: Ability to capture software develop terms and transfer Subject Matter Experts knowledge to documents
Software Validation
Strong Evaluative Skills
System Verification
Written & Verbal Communication Skills
Microsoft Visio
Documenting: Expert in creating new design requirements documents including User requirements, System Overview and Configuration, Validation, and Security Plans required for GMP automation platforms.
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