Contract Technical Writer

Contract Technical Writer – CAPA/SOP Remediation

Location: Raleigh, NC (On-site)

Pay Rate: $40–$47/hour

Engagement Type: Contract

Schedule: Monday-Friday 8am-5pm

Duration: Initial 6–8 weeks with strong potential for extension

Openings: 2

Overview

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.

Responsibilities

• 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.

Qualifications

• 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.

Position Details

• 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.