Quality Assurance Specialist II - Internal Quality

Arrowhead Pharmaceuticals, Inc. (Nasdaq: ARWR) is a commercial-stage biopharmaceutical company developing medicines that treat intractable diseases by silencing the genes that cause them. Using a broad portfolio of RNA chemistries and efficient modes of delivery, Arrowhead therapies trigger the RNA interference (RNAi) mechanism to induce rapid, deep, and durable knockdown of target genes. The company focuses on developing innovative drugs for diseases with a genetic basis, addressing conditions across virtually any therapeutic area and pursuing disease targets not otherwise addressable by small molecules and biologics. Arrowhead leads the field in bringing RNAi therapies to diseases outside the liver, with a clinical pipeline targeting the liver and lung, and a robust preclinical pipeline.

About the role

The Specialist II, Quality Assurance, supports ongoing development programs for preclinical, clinical, and commercial drug candidates. This role involves reviewing manufacturing batch records, analytical data and reports, and other documentation to ensure compliance with current Good Manufacturing Practices (cGMP). The position requires interaction with multiple internal departments and supports general quality systems within the organization.

Responsibilities

• Interact with representatives from manufacturing, QC, and Analytical Development to obtain necessary information for documentation review.
• 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 with minimal supervision.
• Organize and control project-related documentation.
• Issue, review, and reconcile controlled forms.
• Review, verify, and reconcile labels.
• Scan and upload executed documents to the EDMS, categorize them properly, 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.
• Perform additional duties as assigned.

Requirements

• BS/BA in an applicable scientific field such as chemistry, biology, or biochemistry.
• Minimum of 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 and manage priorities in a fast-paced environment.

Preferred Qualifications

• Experience with quality systems supporting GMP regulations (21 CFR Parts 11, 210, 211, and EU GMP, including Annex 11 and 15).
• Competent knowledge of Microsoft Word, Excel, and Smartsheet.
• Prior experience with an electronic document management system in a regulated environment.

Pay

Wisconsin pay range: $70,000 USD - $85,000 USD.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.