Harba Solutions Inc. is hiring: Technical Writer in Indianapolis
Harba Solutions Inc. - Indianapolis, IN, United States, 46262
Work at Harba Solutions Inc.
Overview
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Overview
This range is provided by Harba Solutions Inc.. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.
Base pay range
$65,000.00/yr - $80,000.00/yr
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Responsibilities:
- Develop, write, and revise Standard Operating Procedures (SOPs), Batch Records, Work Instructions, and Technical Reports for GMP manufacturing operations.
- Ensure all documentation complies with FDA, EU, and other regulatory requirements.
- Collaborate with Subject Matter Experts (SMEs) to translate technical processes into clear, concise, and accurate documents.
- Review and edit existing documents to improve clarity, consistency, and compliance with GMP guidelines.
- Assist in document control processes, including version control, approvals, and archival.
- Support training programs by developing training materials and ensuring documentation is user-friendly.
- Work with Quality Assurance to manage deviations, CAPAs, and change control documentation.
- Maintain an up-to-date knowledge of current industry regulations, best practices, and emerging trends in GMP documentation.
Qualifications:
- Bachelor’s degree in Technical Writing, Life Sciences, Engineering, or a related field.
- 2-5 years of experience in technical writing within a GMP-regulated pharmaceutical, biotechnology, or medical device manufacturing environment.
- Strong understanding of FDA, EU GMP, ICH, and ISO documentation requirements.
- Proficiency in Microsoft Office (Word, Excel, PowerPoint), document management systems (e.g., Veeva, MasterControl, Documentum).
- Excellent writing, editing, and proofreading skills with a strong attention to detail.
- Ability to work collaboratively with cross-functional teams and meet deadlines in a fast-paced environment.
- Experience with process mapping, risk assessment documentation, and training material development is a plus.
Seniority level
Mid-Senior level
Employment type
Full-time
Job function
Writing/Editing, Manufacturing, and Science
Industries
Pharmaceutical Manufacturing, Biotechnology Research, and Medical Equipment Manufacturing
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