Quality Specialist III, GxP Conformity & Continuous Improvement

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.
• Affirm compliance with applicable regulations, international standards, and internal procedures.
• Afford assistance 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.

Qualifications

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

Benefits

Arrowhead provides competitive salaries and an excellent benefit package.