Quality Assurance Specialist II

Arrowhead Pharmaceuticals•Madison, WI

5d•$70,000 - $85,000

About The Position

Arrowhead Pharmaceuticals is a commercial-stage biopharmaceutical company developing RNA interference-based medicines for diseases with a genetic basis. The Quality Assurance Specialist II provides quality oversight for GLP/GCLP-compliant bioanalytical and biomarker activities. The role conducts audits, collaborates with stakeholders, and helps ensure study compliance with regulatory standards. It manages QA activities across assigned clinical and nonclinical studies and may mentor QA Specialist I personnel.

Requirements

Bachelor’s degree in a scientific field.
At least 3 years of GLP/GCLP quality assurance experience in pharmaceutical or CRO settings.
Knowledge of OECD GLP, FDA/EMA regulations, ICH M10, and 21 CFR Part 11.
Working experience auditing HPLC, LC-MS/MS, and ELISA.
Excellent communication skills and experience drafting audit reports.
Excellent interpersonal, verbal, and written communication skills.
Ability to communicate professionally with external parties.
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.
Current, valid authorization to work in the country where the role is located.

Nice To Haves

Master’s degree.
ASQ Certified Quality Auditor (CQA) or equivalent certification.
Experience supporting biologics, gene therapies, or biomarkers in oncology or rare disease programs.
Familiarity with electronic systems including Veeva Vault QMS, LIMS, and eTMF.

Responsibilities

Independently plan, conduct, and report study-specific audits, including method validation and sample analysis phases.
Review and approve study protocols, validation reports, and analytical plans for QA compliance.
Audit raw data, including chromatography and LIMS data, for integrity and regulatory alignment.
Support regulatory readiness efforts, including preparing responses to audit findings.
Manage QA activities across assigned clinical and nonclinical studies.
Lead non-conformance investigations and draft comprehensive CAPAs.
Identify quality-improvement opportunities and update audit tools or SOPs accordingly.
Serve as QA liaison for assigned projects and ensure proper documentation in systems such as LIMS or Vault.
May mentor QA Specialist I personnel and contribute to their onboarding.