Contract Technical Writer

Kelly Science, Engineering, Technology & Telecom; Raleigh (NC); On-site; USD 55,000 - 65,000; Full time

Job summary

Kelly Science, Engineering, Technology & Telecom is seeking Contract Technical Writers to support a GMP-regulated CAPA/SOP remediation initiative at a Raleigh, NC facility. The role involves updating and creating GMP-compliant documentation and collaborating with Quality, Manufacturing, and Laboratory teams to meet regulatory standards.

This on-site contract project requires 3+ years of GMP technical writing experience and offers a pay rate of $40-$47/hour for an initial 6-8 week engagement with

Qualifications

• 3+ years technical writing in a GMP-regulated environment.
• Bachelor's degree or equivalent in a regulated manufacturing field.
• Experience writing SOPs, batch records, work instructions, and lab documentation.
• Knowledge of CAPA processes and document control.

Responsibilities

• Revise and update 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 SMEs into compliant documentation.
• Ensure documents comply with cGMP and internal quality systems.
• Track documentation against project timelines and CAPA due dates.
• Collaborate with cross-functional teams to verify technical accuracy before approval.
• Utilize EDMS to draft, route, and maintain documentation.

Skills

Technical writing

GMP compliance

SOP development

CAPA processes

Documentation

Regulatory compliance

Independent work

Education

Bachelor's degree in scientific/technical field

Tools

MS Office

EDMS

Job description

Contract Technical Writer - CAPA/SOP Remediation

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.
• 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.