GMP Technical Writer

GMP Technical Writer

Contract: 12 - 18 months duration

Location: Kenosha County, WI. – onsite

Role Summary:

ASI is seeking a GMP Technical Writer with engineering documentation experience to support backlog closure across Deviations (DEVs), CAPAs, and Change Controls at the Kenosha County site. 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.

•      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 QualityDocs and/or MasterControl 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

Requirements

Required Qualifications:

•      3–6+ 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 QualityDocs, MasterControl, or TrackWise

•      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