Biopharma QA Specialist II — GMP & Documentation Expert

Arrowhead Pharmaceuticals; Madison (WI); Hybrid; USD 70,000 - 110,000; Full time

Benefits offered by this job

Competitive salary

Benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Quality Assurance Specialist II to support ongoing development programs for preclinical, clinical, and commercial drug candidates.

The role focuses on reviewing manufacturing batch records, analytical data, and related documents to ensure cGMP compliance and data integrity. The position requires a BS/BA in a scientific field, 3+ years of QA experience in biotech/pharma, strong communication, and organizational skills.

Qualifications

• BS/BA in a scientific field such as chemistry, biology, or biochemistry.
• Minimum 3 years of quality assurance or similar experience in a biotech or pharmaceutical development, manufacturing, or contract manufacturing organization.
• Working knowledge of GMP, GCP, and/or GLP regulations as well as ICH and FDA guidance documents.
• Excellent interpersonal, verbal, and written communication skills.
• Ability to consistently communicate with external parties in a professional manner.
• Ability to follow company procedures, work instructions, and policies.
• Excellent attention to detail and organizational skills.
• Ability to work independently with minimal supervision as well as manage priorities within a fast-paced environment.

Responsibilities

• Interact with representatives from other departments to obtain information for review of documentation.
• Review and approve analytical testing data and final reports from internal and external sources with minimal supervision.
• Review and approve manufacturing batch records, forms, and associated testing with minimal supervision.
• Review and approve internally generated raw material data and documentation with minimal supervision.
• Perform lot disposition and release of raw materials with minimal supervision.
• Perform room releases as required.
• Perform QA on the floor as required.
• Assist with investigations and deviations as appropriate with minimal supervision.
• Organization and control of project related documentation.
• Issue, review, and reconcile controlled forms.
• Review, verify, and reconcile labels.
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval.
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Assist with Good Documentation Practices, GMP, and data integrity training as needed.
• Additional duties as assigned.

Skills

Communication skills

Attention to detail

Independent work

Prioritization

Documentation

Education

BS/BA in science

Tools

Microsoft Word

Excel

Smartsheet

EDMS

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a Quality Assurance Specialist II to support ongoing development programs for preclinical, clinical, and commercial drug candidates.

The role focuses on reviewing manufacturing batch records, analytical data, and related documents to ensure cGMP compliance and data integrity. The position requires a BS/BA in a scientific field, 3+ years of QA experience in biotech/pharma, strong communication, and organizational skills.