GMP Deviation & CAPA Documentation Lead

cGMP Consulting Inc.; Joliet (IL); On-site; USD 80,000 - 95,000; Full time

Benefits offered by this job

Medical

Dental

Vision

PTO

401K

Job summary

cGMP Consulting is seeking a motivated professional to lead technical writing for quality system records in a GMP environment. The role involves deviations, change controls, and CAPAs with collaboration across Manufacturing, Quality, and Engineering.

The ideal candidate will demonstrate independent work, strong writing skills, and a solid understanding of cGMP and FDA guidelines, contributing to compliant, inspection-ready documentation.

Qualifications

• Bachelor's degree in Engineering, Science, English/Communications or related field.
• 2-5 years’ experience in a GMP manufacturing environment, including drafting SOPs, protocols, and/or reports.
• Hands-on experience authoring deviations, change controls, and CAPAs in a GMP quality system (e.g., TrackWise, Veeva, or similar QMS).
• Advanced critical thinking and technical writing skills, with strong attention to detail.
• Strong organizational, communication, and interpersonal skills.

Responsibilities

• Author, revise, and review deviation records with descriptions, impact, risk, root cause, and CAPAs.
• Author and manage change controls with descriptions, justifications, impact assessments, and implementation plans.
• Draft, track, and support closure of CAPAs with action plans and effectiveness checks.
• Interview SMEs to gather technical information for clear, inspection-ready docs.
• Author and revise SOPs, work instructions, and reports including updates from CAPA/change control.

Skills

Technical writing

GMP knowledge

Regulatory compliance

Attention to detail

Communication

Education

Bachelor's degree in Engineering, Science, English/Communications

Tools

TrackWise

Veeva

Quality Management System (QMS)

Job description

cGMP Consulting is seeking a motivated professional to lead technical writing for quality system records in a GMP environment. The role involves deviations, change controls, and CAPAs with collaboration across Manufacturing, Quality, and Engineering.

The ideal candidate will demonstrate independent work, strong writing skills, and a solid understanding of cGMP and FDA guidelines, contributing to compliant, inspection-ready documentation.