GMP Documentation Lead: Deviations & CAPAs

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. 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