Contract Technical Writer

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

Benefits offered by this job

Medical benefits

Dental benefits

Vision benefits

Transit benefits

Paid holidays

Job summary

Kelly seeks multiple Contract Technical Writers to support CAPA/SOP remediation at a regulated facility. You will update GMP-compliant documents, including SOPs, batch records, and lab forms, in collaboration with Quality, Manufacturing and Laboratory teams.

This on-site Raleigh, NC role is 6–8 weeks with potential extension. Initial 3–4 contract openings are available immediately, with a Monday–Friday schedule and on-site work.

Qualifications

• 3 years of GMP-regulated technical writing experience.
• Experience writing SOPs, batch records, and lab docs.
• Knowledge of CAPA, document control and quality systems.

Responsibilities

• Revise SOPs to support CAPA closure activities.
• Author, revise, and format technical documentation including batch records and lab forms.
• Translate input from Quality, Manufacturing, and Laboratory SMEs into compliant documents.
• Ensure all 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 electronic document management and change control systems.

Skills

Technical writing

GMP compliance

CAPA processes

Independent work

Education

Bachelor's degree or equivalent

Tools

Microsoft Office

EDMS

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.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California’s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

Kelly may use AI-powered tools during the recruitment and hiring process. For full details, including how Kelly uses AI, your rights, and how to request a reasonable accommodation, visit the Recruitment Artificial Intelligence Notice.