Quality Specialist III, GxP Conformity & Continuous Improvement

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

Benefits offered by this job

Competitive salary

Excellent benefits package

Job summary

Arrowhead Pharmaceuticals seeks a QA Specialist III to support Product Complaints and Quality Events, conducting investigations and CAPAs within the eQMS system. You will assess actions, track quality metrics, and ensure timely, thorough investigations for conformance events.

Responsibilities include reviewing Quality Events, identifying root causes, communicating trends, and assisting audits. Proficiency with Word, Excel, and Smartsheet is required to ensure documentation accuracy and

Qualifications

• 6 years of experience in a regulated environment, preference for quality assurance auditing.
• Knowledge of drug GMP regulations and ICH/FDA guidance documents.
• Proficient in Microsoft Word, Excel, and Smartsheet.

Responsibilities

• Support eQMS workflows related to Quality Events, Product Complaints, and Internal Audits.
• Review, track, and approve Quality Events within eQMS.
• Identify root causes and determine corrective and preventive actions.
• Review the adequacy of CAPAs.
• Identify, communicate, and elevate observed trends with internal stakeholders.
• Prepare and present data and trends to internal stakeholders.
• Interact with representatives from other departments to investigate and close product complaints within eQMS.
• Manage product complaint tracking, escalation, and trending.
• Write, review, and approve procedural documents.
• Participate in and support audits and inspections.
• Ensure compliance with applicable regulations, international standards, and internal procedures.
• Assist with other QA duties as needed.

Skills

Quality Assurance

Regulatory knowledge

Documentation skills

Tools

Microsoft Word

Microsoft Excel

Smartsheet

Job description

The Position

The QA Specialist III role is responsible for supporting Product Complaints and Quality Events, including laboratory investigations, deviations, continuous improvement initiatives, and CAPAs within Arrowhead Pharmaceutical’s eQMS (Veeva). This position will ensure that timely, efficient, and thorough investigations are conducted for conformance events, assess the suitability and adequacy of determined subsequent actions, and support continued tracking/trending of quality metrics.

Responsibilities

• Support eQMS workflows related to Quality Events, Product Complaints, and Internal Audits.
• Review, track, and approve Quality Events within eQMS.
• Support operations with identifying root causes and determining corrective and preventive actions.
• Review the adequacy of CAPAs.
• Identify, communicate, and elevate observed trends with internal stakeholders.
• Prepare and present data and trends to internal stakeholders.
• Interact with representatives from other departments to investigate and close product complaints within eQMS.
• Manage product complaint tracking, escalation, and trending.
• Write, review, and approve procedural documents.
• Participate in and support audits and inspections.
• Ensure compliance with applicable regulations, international standards, and internal procedures.
• Assist with other QA duties as needed.

Requirements

• 6 years of experience working in a regulated environment, with a preference for quality assurance auditing.
• Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents.
• Competent knowledge of and ability to use Microsoft Word, Excel, and Smartsheet.

Preferred

• Previous experience with quality systems supporting drug-device combination products per 21 CFR Part 3 and medical devices QSR per 21 CFR Part 820/ISO 13485.

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.

Candidates must have current, valid authorization to work in the country where this role is located.