GMP Technical Writer - Onsite in Madison (Contract-to-Hire)

Automated Systems, Inc.; Madison (WI); On-site; USD 69,000 - 96,000; Full time

Job summary

Automated Systems, Inc. seeks a GMP Technical Writer to support documentation and quality system activities at a pharmaceutical site in the Greater Madison Area. This role requires translating complex technical information from engineers into clear, audit-ready GMP documentation.

The position covers backlog closure for Deviations, CAPAs, Change Controls, SOPs, and engineering docs, working with Automation, Utilities, and Facilities teams. Strong GMP knowledge and meticulous editing are essential.

Qualifications

• 4+ years GMP technical writing experience in regulated environments.
• Authoring Deviations, CAPAs, Change Controls, SOPs, and Work Instructions.
• Experience with Deviation investigations and CAPA processes.
• Strong understanding of cGMP, data integrity, and document control practices.
• Experience with electronic quality management systems (Veeva/MasterControl/TrackWise).
• Smartsheet and Excel used for tracking and coordination.

Responsibilities

• Author, revise, and finalize GMP documentation (deviations, CAPAs, change controls, SOPs, work instructions).
• Collaborate with Automation, Utilities, and Facilities engineers to source technical information and translate to GMP-compliant docs.
• Support deviation investigations and root cause analysis with corrective and preventive actions.
• Manage document workflows in Veeva Quality Docs, MasterControl, or equivalent systems.
• Edit SOPs, work instructions, and related controlled documents per quality requirements.
• Maintain documentation trackers using Smartsheet, Excel, or similar tools.
• Coordinate interdependencies across engineering and quality to prevent delays and backlogs.
• Ensure documentation meets cGMP, data integrity, and audit-readiness requirements.

Skills

GMP documentation

Technical writing

Data integrity

Cross-functional coordination

Education

Bachelor’s degree in technical field

Tools

Veeva Quality Docs

MasterControl

Smartsheet

TrackWise

Job description

Automated Systems, Inc. seeks a GMP Technical Writer to support documentation and quality system activities at a pharmaceutical site in the Greater Madison Area. This role requires translating complex technical information from engineers into clear, audit-ready GMP documentation.

The position covers backlog closure for Deviations, CAPAs, Change Controls, SOPs, and engineering docs, working with Automation, Utilities, and Facilities teams. Strong GMP knowledge and meticulous editing are essential.