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Actalent Quality Technical Writer in Noblesville, Indiana

SEEKING Quality Technical Writer

Job Description

This role involves supporting the documentation for a new product scheduled for production in the coming years. The primary goal is to prepare a submission to the FDA by August, with more products anticipated in the pipeline, making this an ongoing opportunity. As a Quality Technical Writer, you will develop and write validation protocols, test scripts, reports, and user manuals for spreadsheets used in regulated environments. Additionally, you will create and maintain documentation templates for spreadsheet validation, review and edit documents for accuracy, completeness, and consistency, track document status, manage document revisions and updates, implement improvements in spreadsheet validation processes and documentation practices, and manage and prioritize projects in an organized and structured manner. You must maintain operational compliance with US and international regulatory agencies and guidelines.

Hard Skills

  • Bachelors Degree in Engineering or related field

  • Technical Writing experience

  • Experience with GMP / cGMP regulations

Soft Skills

  • Ability to manage and prioritize projects

  • Strong organizational skills

  • Excellent documentation and editing skills

Work Site

This is a fully on-site position in Noblesville, Indiana.

Work Environment

This role is based in our Noblesville, Indiana location. The work involves ongoing projects with a focus on compliance and excellence in documentation for new product introductions. You will work in a structured environment that prioritizes operational compliance and documentation accuracy.

About Actalent

Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500.

Diversity, Equity & Inclusion

At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through:

  • Hiring diverse talent

  • Maintaining an inclusive environment through persistent self-reflection

  • Building a culture of care, engagement, and recognition with clear outcomes

  • Ensuring growth opportunities for our people

The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.

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