The PositionThe 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 escalate 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- Bachelor's degree
- 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.
Wisconsin pay range
$78,000-$98,000 USD
Arrowhead provides competitive salaries and an excellent benefit package.
