Contract Technical Writer
Job Description
Contract Technical Writer – CAPA/SOP Remediation
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Location: Raleigh, NC (On-site)
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Pay Rate: $40–$47/hour
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Engagement Type: Contract
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Schedule: Monday-Friday 8am-5pm
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Duration: Initial 6–8 weeks with strong potential for extension
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Openings: 2
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Overview
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We are seeking multiple Contract Technical Writers to support a high-priority documentation remediation initiative at a regulated manufacturing facility. This project focuses on reducing a backlog of CAPA-related documentation by updating and creating GMP-compliant technical documents. The team will work collaboratively with Quality, Manufacturing, and Laboratory personnel to ensure documentation meets regulatory and internal quality standards.
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Responsibilities
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- Revise and update Standard Operating Procedures (SOPs) to support CAPA closure activities.
- Author, revise, and format technical documentation, including batch records and laboratory forms.
- Translate input from Quality, Manufacturing, and Laboratory subject matter experts into clear, compliant documentation.
- Ensure all documents comply with cGMP requirements and internal quality systems.
- Track assigned documentation against project timelines and CAPA due dates.
- Collaborate with cross-functional teams to verify technical accuracy before document approval.
- Utilize electronic document management and change control systems to draft, route, and maintain documentation.
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Qualifications
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- Bachelor's degree in a scientific, technical, engineering, or communications-related field preferred; equivalent regulated manufacturing experience will be considered.
- 3+ years of technical writing experience in a GMP-regulated pharmaceutical, biotech, medical device, or similar manufacturing environment.
- Experience authoring and revising SOPs, batch records, work instructions, and laboratory documentation.
- Working knowledge of CAPA processes, document control, and quality management systems.
- Strong technical writing skills with an emphasis on clarity, consistency, and regulatory compliance.
- Ability to work independently in a fast-paced, deadline-driven environment.
- Proficiency with Microsoft Office and electronic document management systems.
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Position Details
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- 3–4 contract openings available immediately.
- Initial project expected to last 6–8 weeks, with a strong possibility of extension based on ongoing documentation needs.
- This is a fully on-site position in Raleigh, NC.
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