GMP Technical Writer
Job in
Milwaukee, Milwaukee County, Wisconsin, 53244, USA
Listed on 2026-08-19
Listing for:
Automated Systems, Inc. (ASI)
Full Time
position Listed on 2026-08-19
Job specializations:
-
Quality Assurance - QA/QC
QA Specialist - Analyst/Manager, Quality Engineering, Regulatory Compliance Specialist
Job Description & How to Apply Below
Automated Systems, Inc. is seeking a GMP Technical Writer with engineering documentation experience to support backlog closure across Deviations (DEVs), CAPAs, and Change Controls at one of our clients pharmaceutical manufacturing sites located in the Kenosha County Area, WI.
This is a cross-discipline support role embedded with the Engineering team, providing structured writing, document control, and quality system support to Automation, Utilities, and Facilities engineers who need bandwidth relief to focus on active project execution.
Key Responsibilities- Author and finalize GMP documents including Deviation reports, CAPA records, Change Control packages, and engineering work orders.
- Interface with Automation, Utilities, and Facilities engineers to gather technical content and translate to GMP-compliant documentation.
- Manage document routing in Veeva Quality Docs and/or Master Control through review, approval, and effective date cycles.
- Draft and revise SOPs, Work Instructions, and engineering procedures to meet LQS/GQS requirements.
- Maintain documentation trackers (Smartsheet, Excel) for open items, approval queues, and closure timelines.
- Support change control classification and rationale documentation under applicable site SOPs.
- Coordinate cross-discipline document interdependencies to prevent routing bottlenecks.
- 4+ years of GMP technical writing experience in pharmaceutical, biotech, or medical device manufacturing.
- Demonstrated experience authoring Deviation reports, CAPA records, and Change Control packages.
- Proficiency with electronic quality management systems — Veeva Quality Docs, Master Control, or Track Wise.
- Strong understanding of GMP documentation principles (data integrity, version control, review/approval workflows).
- Excellent written communication and ability to distill complex engineering information into compliant, auditable documents.
- Experience supporting engineering-side documentation (automation, utilities, or facilities).
- Familiarity with quality systems or equivalent top-tier pharma QMS frameworks.
- Exposure to legacy site remediation or quality system transition projects.
- Proficiency in Smartsheet or equivalent project tracking platforms.
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