Quality Documentation & Training Specialist III

Arrowhead Pharmaceuticals, Inc.; Verona (WI); On-site; USD 78,000 - 98,000; Full time

Job summary

Arrowhead Pharmaceuticals, Inc. is seeking an experienced Document Control and Training Compliance professional to support day-to-day quality assurance activities at our Wisconsin facilities.

You will manage controlled documents, training records, and GxP documentation within the eQMS and LMS systems, ensuring accuracy, traceability, and regulatory compliance. The role focuses on document control, records management, and training administration, working with cross-functional teams to prepare

Qualifications

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry.
• Minimum of 5 years of experience in a pharmaceutical/biotech company, contract manufacturing organization or contract research organization writing and maintaining documents.
• Ability to follow company procedures, work instructions, and policies.
• Ability to multi-task and prioritize work with minimal supervision.
• Excellent interpersonal, verbal, and written communication skills.
• Strong organizational skills with the ability to manage multiple tasks, prioritize workload, and meet competing deadlines.

Responsibilities

• Document Control and Records Management: Support formatting, metadata entry, routing, approval workflows, effective date coordination, periodic review activities, and controlled document lifecycle maintenance.
• Support issuance, reconciliation, and review of controlled documents and completed records to verify completeness and compliance with GxP requirements.
• Maintain organized and audit-ready document control files, including effective documents, superseded or obsolete records, document change records, and supporting documentation.
• Support preparation and organization of document control packages for internal audits, client audits, regulatory inspections, and document change control activities.
• Assist with controlled copy management, document distribution, retrieval, archival, and record retention activities, as applicable.
• Assist with the development, revision, and maintenance of document control work instructions and SOPs, as directed.
• Support formatting and routing of corporate policies through approval workflows, and coordinate periodic review timing with Legal, Health Care Compliance, IS&I and applicable stakeholders.
• Perform additional duties as assigned.
• Training Administration and Compliance: Monitor training completion rates, identify at-risk or past-due training items, and proactively elevate concerns, as applicable.
• Assist in developing and updating training materials, including slide decks, assessments, and Read-and-Understand documents for GxP and SOP-based training programs.
• Support new hire orientation and classroom training activities.
• Compile and organize training completion data and generate routine compliance reports for review by management.
• Maintain training records in an organized, accurate, and audit-ready state.
• Perform additional duties as assigned.

Skills

Document control

Training administration

GxP compliance

Multitasking

Communication

Education

BS/BA in science

Tools

Veeva

LMS software

Adobe Acrobat

Microsoft Word

PowerPoint

Excel

Job description

Arrowhead Pharmaceuticals, Inc. is seeking an experienced Document Control and Training Compliance professional to support day-to-day quality assurance activities at our Wisconsin facilities.

You will manage controlled documents, training records, and GxP documentation within the eQMS and LMS systems, ensuring accuracy, traceability, and regulatory compliance. The role focuses on document control, records management, and training administration, working with cross-functional teams to prepare