Senior Quality Documentation Specialist

Arrowhead Pharmaceuticals; Madison (WI); On-site; USD 80,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Excellent benefits

Job summary

Arrowhead Pharmaceuticals is seeking an experienced QA Document Control and Training Compliance specialist in Madison, WI. You will manage controlled documents, records, and training within the eQMS and LMS systems, ensuring accuracy and regulatory compliance.

Responsibilities include creating and maintaining SOPs, supporting audits, and generating compliance reports. Candidates should have 5+ years in pharma/biotech, strong organizational skills, and excellent communication abilities.

Qualifications

• BS/BA in an applicable scientific field and relevant regulatory experience are required.
• Minimum of 5 years in a pharma/biotech setting writing and maintaining documents.

Responsibilities

• Support document formatting, metadata entry, routing, approvals, and lifecycle maintenance.
• Maintain audit-ready document control files and change records.
• Assist with document control packages for internal and regulatory audits.
• Support training material development and distribution for GxP/SOP training.
• Monitor training completion, generate compliance reports, and keep records organized.

Skills

Communication

Organization

Multi-tasking

Procedural compliance

Education

BS/BA in chemistry or biology or biochemistry

Tools

Veeva or similar eQMS

LMS software

Adobe Acrobat

MS Office (Word, PowerPoint, Excel)

Job description

Arrowhead Pharmaceuticals is seeking an experienced QA Document Control and Training Compliance specialist in Madison, WI. You will manage controlled documents, records, and training within the eQMS and LMS systems, ensuring accuracy and regulatory compliance.

Responsibilities include creating and maintaining SOPs, supporting audits, and generating compliance reports. Candidates should have 5+ years in pharma/biotech, strong organizational skills, and excellent communication abilities.