QA Specialist II - GLP/GCLP Audits & Compliance

Arrowhead Pharmaceuticals, Inc.; Madison (WI); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Competitive salaries

Excellent benefits package

Job summary

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a QA Specialist II to provide quality oversight for GLP/GCLP bioanalytical and biomarker activities.

The QA Specialist II conducts audits, collaborates with stakeholders, and ensures that studies are compliant with regulatory standards. You will plan and conduct audits, review protocols, manage QA activities across studies, lead non-conformance investigations, and support regulatory readiness.

Qualifications

• Bachelor's degree in a scientific field.
• 3+ years of GLP/GCLP QA experience in pharma 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 and audit-report writing skills.
• Excellent interpersonal, verbal, and written communication skills.
• 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

• 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 (chromatography, LIMS) 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.
• Proactively identify areas for quality improvement and update audit tools or SOPs accordingly.
• Serve as QA liaison for assigned projects and ensure proper documentation in systems like LIMS or Vault; mentor QA Specialist I personnel.

Skills

GLP/GCLP QA experience

Audit experience

Communication skills

Independence

Prioritization

Education

Bachelor’s degree in a scientific field

Tools

LIMS

Veeva Vault QMS

eTMF

HPLC

LC-MS/MS

ELISA

Job description

Arrowhead Pharmaceuticals, Inc. in Madison, WI is seeking a QA Specialist II to provide quality oversight for GLP/GCLP bioanalytical and biomarker activities.

The QA Specialist II conducts audits, collaborates with stakeholders, and ensures that studies are compliant with regulatory standards. You will plan and conduct audits, review protocols, manage QA activities across studies, lead non-conformance investigations, and support regulatory readiness.