GMP Technical Writer
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.
