GMP Technical Writer

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

Contract: 6+ months with strong potential for contract-to-hire

Location: Greater Madison Area, WI — Onsite

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. This role will support backlog closure across Deviations, CAPAs, Change Controls, SOPs, and engineering documentation, working closely with Automation, Utilities, and Facilities engineering teams.

The ideal candidate will combine strong technical writing skills with pharmaceutical GMP experience and a solid understanding of quality systems and document control. This position requires the ability to gather complex technical information from engineers and translate it into clear, accurate, compliant, and audit-ready documentation.

Key Responsibilities

• Author, revise, and finalize GMP documentation, including Deviation reports, CAPAs, Change Controls, engineering work orders, SOPs, and Work Instructions.
• Partner with Automation, Utilities, and Facilities engineers to gather technical information and translate engineering concepts into clear, GMP-compliant documentation.
• Support Deviation investigations, root cause documentation, corrective and preventive actions, and Change Control packages, including classification and rationale.
• Manage document workflows through Veeva QualityDocs, MasterControl, or comparable electronic quality management systems, including review, approval, and effective-date processes.
• Author and edit SOPs, Work Instructions, engineering procedures, and related controlled documents in accordance with site and global quality requirements.
• Maintain documentation trackers using Smartsheet, Excel, or similar tools to monitor open items, approval queues, dependencies, and closure timelines.
• Coordinate document interdependencies across engineering and quality functions to prevent routing delays and support timely closure of documentation backlogs.
• Ensure documentation meets cGMP, data integrity, document control, version control, and audit-readiness requirements.
• Apply strong attention to detail and critical thinking when reviewing technical content for accuracy, completeness, consistency, and compliance.
• Support electronic documentation and quality systems while learning and applying site-specific procedures, processes, and technologies.

Required Qualifications & Experience

• 4+ years of GMP technical writing experience within pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Demonstrated experience authoring Deviations, CAPAs, Change Controls, SOPs, Work Instructions, and other GMP-controlled documentation.
• Experience supporting Deviation investigations and CAPA processes, including documenting root causes, corrective actions, and preventive actions.
• Strong understanding of cGMP documentation practices, 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, or equivalent platforms.
• Experience using Smartsheet, Microsoft Excel, and Microsoft Office for documentation tracking and project coordination.
• Relevant experience supporting engineering organizations, particularly Automation, Utilities, Facilities, Manufacturing, or related technical functions.
• Strong technical writing and editing skills, with the ability to translate complex technical information into clear, concise, compliant, and audit-ready documentation.
• Excellent attention to detail, organization, critical thinking, and problem-solving skills.
• Ability to work effectively with engineers, Quality, Operations, and other cross-functional stakeholders in a fast-paced pharmaceutical manufacturing environment.
• Bachelor’s degree in a relevant discipline such as Technical Writing, Engineering, Science, Business, Computer Science, or a related field, or equivalent combination of education and experience.

Preferred Qualifications

• 1–2+ years of pharmaceutical industry experience in a GMP-regulated environment.
• Experience authoring or maintaining electronic batch record recipes.
• Familiarity with systems such as ComplianceWire, JD Edwards, Unicorn, or similar pharmaceutical quality/manufacturing platforms.
• Working knowledge of manufacturing and laboratory operations and the ability to quickly learn new processes, systems, and technologies.
• Experience supporting quality system backlog reduction, documentation remediation, or continuous improvement initiatives.