Contract GMP Writer: CAPA & SOP Remediation (On-Site)

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

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.