Lead, Documentation Specialist

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 75,000 - 105,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking an experienced document specialist to draft, edit, and standardize GMP documentation for deviations, investigations, CAPAs, and change controls. You will ensure records are clear, compliant, and inspection-ready, aligning with data integrity and site procedures.

Collaboration with SMEs and cross-functional owners is essential. Ideal candidates have a BS/BA in a scientific field and 3 years of GMP experience, including authoring change controls and

Qualifications

• BS/BA in an applicable scientific field (chemistry, biology, biochemistry).
• 3 years GMP experience with at least 2 years authoring change controls and/or investigating deviations.
• Proficient experience with controlled documentation.
• Experience with internal CAPA investigations.
• Ability to collaborate with cross-functional teams.
• Proficiency with Microsoft Word and Excel.

Responsibilities

• Draft, edit, and standardize GMP documentation for deviations, investigations, CAPAs, and change controls.
• Translate SME input into clear root-cause documentation with evidence-based conclusions.
• Draft CAPAs linked to root cause, including action plans and effectiveness checks.
• Draft change controls with rationale, scope, and implementation plan.
• Ensure records are complete, traceable, and inspection-ready with attachments and evidence.
• Apply site procedures and data integrity/cGMP expectations in QMS records.

Skills

GMP documentation

Deviation investigation

CAPA investigations

Change controls

Cross-functional collaboration

Education

BS/BA in Chemistry, Biology or Biochemistry

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. (Nasdaq ARWR) is a commercial stage biopharmaceutical company that develops medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference mechanism to induce rapid, deep, and durable knockdown of target genes. RNA interference, or RNAi, is a mechanism present in living cells that inhibits the expression of a specific gene, thereby affecting the production of a specific protein. Arrowhead's RNAi-based therapeutics leverage this natural pathway of gene silencing.

Arrowhead is focused on developing innovative drugs for diseases with a genetic basis, typically characterized by the overproduction of one or more proteins that are involved with disease. The depth and versatility of our RNAi technologies enables us to potentially address conditions in virtually any therapeutic area and pursue disease targets that are not otherwise addressable by small molecules and biologics. Arrowhead is leading the field in bringing the promise of RNAi to address diseases outside of the liver, and our clinical pipeline includes disease targets in the liver and lung with a promising pipeline of preclinical candidates.

Arrowhead's corporate headquarters is in Pasadena, CA with research and development teams in Madison, WI & San Diego, CA, and a state of the art manufacturing facility in Verona, WI. Our employees are nimble, science-driven innovators who are collaborating to bring new therapies to patients in need.

The Position

This position will be primarily responsible for drafting, editing, and standardizing GMP documentation for deviations, investigations, CAPAs, and change controls. Ensures records are clear, compliant, complete, and inspection-ready, aligning to site procedures, data integrity expectations, and applicable regulations. Partners with SMEs and cross-functional owners to translate technical content into high-quality QMS records with consistent structure and strong rationale.

Responsibilities

• 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).
• Apply site procedures and data integrity / cGMP expectations in all Manufacturing QMS records.
• 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.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry
• 3 years working in a GMP setting with a minimum of 2 years of experience authoring change controls and/or investigating deviations.
• Proficient experience working with controlled documentation
• Experience with internal CAPA investigations
• Ability to collaborate with and coordinate cross-functional teams
• Proficiency with Microsoft Suite applications (Word, Excel)
• High attention to detail
• Ability to multi-task and manage responsibilities within ongoing projects

Preferred

• 5+ year's GMP experience and 3+ cGMP deviation and/or change control experience.

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.