Hiring: Lead, Documentation Specialist Company: Arrowhead Pharmaceuticals Location: Madison, WI Job Posted Time: 2026-09-10 11:14:01 Target Skills & Keywords : Microsoft Excel, Project Management About the job Experience: •3 years working in a GMP setting with a minimum of 2 years of experience authoring change controls and/or investigating deviations. •5+ year's GMP experience and 3+ cGMP deviation and/or change control experience. Required Skills: •Draft and edit deviations and investigation narratives (event description, timeline, impact, conclusions). •Convert SME input into clear root cause documentation aligned to evidence. •Write CAPAs linked to root cause, including action plans and effectiveness checks. •Draft change controls (rationale, scope, impacted areas/docs, implementation plan). •Ensure records are complete, consistent, and inspection-ready (traceability, attachments, objective evidence). •Coordinate with cross-functional owners to improve first-pass approvals and ensure thorough investigations. •Support audits/inspections by quickly clarifying or revising QMS narratives as needed. •Demonstrated capacity to collaborate with and coordinate cross-functional teams Qualifications: •BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry •Proficient experience working with controlled documentation •Wisconsin pay range: $85,000 USD - $98,000 USD •Arrowhead provides competitive salaries and an excellent benefit package. •Candidates must have current, valid authorization to work in the country where this role is located. Interested candidates, please apply directly through the job posting on company's career page or try via AI auto apply on this platform. Don't miss this opportunity to join a forward-thinking team!