Contract Technical Writer

Kelly Services; Raleigh (NC); On-site; USD 55,000 - 65,000; Full time

Job summary

Kelly Services is seeking multiple Contract Technical Writers to support CAPA/SOP remediation at a regulated manufacturing facility in Raleigh, NC. This on-site role focuses on reducing backlog by updating GMP-compliant documents, collaborating with Quality, Manufacturing, and Laboratory teams.

You will revise SOPs, batch records, and lab forms; ensure cGMP alignment; manage documentation timelines and change control; and use EDMS and MS Office in a fast-paced environment.

Qualifications

• Bachelor’s degree in a scientific/technical field or equivalent regulated manufacturing experience.
• 3+ years of GMP-regulated technical writing experience.
• Experience authoring SOPs, batch records, and lab documentation.
• Knowledge of CAPA processes, document control, and quality management systems.
• Strong writing clarity, regulatory compliance, and independence in fast-paced environments.
• Proficiency with MS Office and electronic document management systems.

Responsibilities

• Revise and update SOPs to support CAPA closure.
• Author, revise, format batch records and lab forms.
• Translate SME input into clear, compliant documentation.
• Ensure documents meet cGMP and internal QA standards.
• Track docs against timelines and CAPA due dates.
• Collaborate with cross-functional teams to verify technical accuracy.
• Use EDMS and change control systems to draft and maintain docs.

Skills

Technical writing

Regulatory compliance

Document control

Cross-functional collaboration

Education

Bachelor’s degree in a scientific/technical field

Tools

Microsoft Office

Job description

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: 3–4

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.