GMP Technical Writer: Quality Systems & Compliance

Automated Systems, Inc. (ASI); Madison (WI); On-site; USD 70,000 - 100,000; Full time

Job summary

Automated Systems, Inc. (ASI) is seeking an experienced GMP Technical Writer to support documentation and quality system activities at a pharmaceutical manufacturing site in the Greater Madison Area.

The role focuses on backlog closure across Deviations, CAPAs, Change Controls, SOPs, and engineering documentation, collaborating with Automation, Utilities, and Facilities teams. The ideal candidate combines strong technical writing with pharmaceutical GMP experience and a solid understanding of

Qualifications

• 4+ years of GMP technical writing experience in regulated manufacturing.
• Experience authoring Deviations, CAPAs, Change Controls, SOPs, Work Instructions and other GMP docs.
• Experience supporting deviation investigations and CAPA processes with root-cause actions.
• Strong understanding of cGMP, data integrity, document control, version control, and review/approval workflows.
• Experience with electronic quality management or document management systems such as Veeva QualityDocs, MasterControl, TrackWise.
• Proficient in using Smartsheet, Excel and MS Office for tracking and coordination.
• Experience supporting Engineering organizations (Automation, Utilities, Facilities, Manufacturing).
• Excellent attention to detail, organization, critical thinking and problem-solving.
• Ability to work with cross-functional stakeholders in fast-paced pharmaceutical manufacturing.

Responsibilities

• Author, revise, and finalize GMP documentation including deviations, CAPAs, Change Controls, SOPs, and work instructions.
• Gather technical information from engineers and translate into GMP-compliant documentation.
• Support deviation investigations and CAPA processes with root-cause documentation and corrective actions.
• Manage document workflows using Veeva QualityDocs, MasterControl, TrackWise, or similar systems.
• Draft and edit SOPs, work instructions, engineering procedures, and related controlled documents.
• Maintain document trackers (Smartsheet, Excel) to monitor open items and approval queues.
• Coordinate document interdependencies to prevent routing delays and support timely closure.
• Ensure compliance with cGMP, data integrity, document control, and audit-readiness.
• Learn and apply site procedures and technologies for electronic documentation.

Skills

GMP technical writing

Cross-functional collaboration

Quality systems documentation

Attention to detail

Audits and audit readiness

Education

Bachelor’s degree in technical writing, engineering, science, or related field

Tools

Veeva QualityDocs

MasterControl

TrackWise

Smartsheet

Excel

Microsoft Office

Job description

Automated Systems, Inc. (ASI) is seeking an experienced GMP Technical Writer to support documentation and quality system activities at a pharmaceutical manufacturing site in the Greater Madison Area.

The role focuses on backlog closure across Deviations, CAPAs, Change Controls, SOPs, and engineering documentation, collaborating with Automation, Utilities, and Facilities teams. The ideal candidate combines strong technical writing with pharmaceutical GMP experience and a solid understanding of