Contract Technical Writer

Contract Technical Writer – CAPA/SOP RemediationLocation: Raleigh, NC (On-site)Pay Rate: $40–$47/hourEngagement Type: ContractSchedule: Monday-Friday 8am-5pmDuration: Initial 6–8 weeks with strong potential for extensionOpenings: 2OverviewWe 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. ResponsibilitiesRevise 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. 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 Details2 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. 000000.