GMP Deviation & CAPA Documentation Lead

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

Benefits offered by this job

Medical, Dental, Vision

401K

Paid Time Off

Job summary

cGMP Consulting Inc. is seeking a motivated technical writer to lead documentation activities for quality system records in a GMP environment. You will author deviations, change controls, and CAPAs, while coordinating with Manufacturing, Quality, and Engineering teams to ensure compliance and accuracy.

The ideal candidate has strong writing skills, attention to detail, and knowledge of FDA guidelines. The role involves cross-functional collaboration, investigations support, and maintaining

Qualifications

• Bachelor's degree in Engineering, Science, English/Communications, or a related field.
• 2-5 years’ GMP manufacturing experience, drafting SOPs/protocols/reports with regulatory familiarity (FDA).
• Experience authoring deviations, change controls, and CAPAs in GMP quality systems.

Responsibilities

• Author, revise, and review deviation records with root cause analyses and CAPAs.
• Manage change controls with justifications and impact assessments across departments.
• Draft and revise SOPs, work instructions, protocols, and reports; ensure GMP/data integrity compliance.
• Lead cross-functional meetings; track action items and escalate overdue items.

Skills

GMP knowledge

Technical writing

Cross-functional collaboration

Education

Bachelor's degree (Engineering/Science/English)

Tools

TrackWise

Veeva

Quality Management System (QMS)

Job description

cGMP Consulting Inc. is seeking a motivated technical writer to lead documentation activities for quality system records in a GMP environment. You will author deviations, change controls, and CAPAs, while coordinating with Manufacturing, Quality, and Engineering teams to ensure compliance and accuracy.

The ideal candidate has strong writing skills, attention to detail, and knowledge of FDA guidelines. The role involves cross-functional collaboration, investigations support, and maintaining