GMP Documentation Lead: Deviations, CAPA & Change Controls

Socket.dev; Verona (WI); On-site; USD 85,000 - 98,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking a GMP Documentation professional to draft, edit, and standardize deviations, investigations, CAPAs, and change controls.

You will ensure records are clear, compliant, and inspection-ready, working with SMEs to translate technical content into high-quality QMS records. The role focuses on applying data integrity expectations and site procedures while coordinating cross-functional owners to improve first-pass approvals and support audits.

Qualifications

• BS/BA in an applicable scientific field (chemistry, biology, or biochemistry).
• 3 years GMP experience with at least 2 years authoring change controls and/or investigating deviations.
• Proficient with controlled documentation and internal CAPA investigations.
• Proficient project management skills; ability to coordinate cross-functional teams.
• Familiar with Microsoft Word and Excel for GMP records.

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 with 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 Manufacturing QMS records.
• Coordinate with cross-functional owners to improve first-pass approvals and ensure thorough investigations.
• Support audits/inspections by clarifying or revising QMS narratives as needed.

Skills

Project management

Cross-functional collaboration

Attention to detail

Multi-tasking

Controlled documentation

Education

BS/BA in chemistry/biology/biochemistry

Tools

Microsoft Word

Microsoft Excel

Job description

Arrowhead Pharmaceuticals, Inc. is seeking a GMP Documentation professional to draft, edit, and standardize deviations, investigations, CAPAs, and change controls.

You will ensure records are clear, compliant, and inspection-ready, working with SMEs to translate technical content into high-quality QMS records. The role focuses on applying data integrity expectations and site procedures while coordinating cross-functional owners to improve first-pass approvals and support audits.