Quality Assurance Specialist

The Position

The purpose of this position within the Quality Assurance department is to support on-going development programs for preclinical and clinical drug candidates at Arrowhead.  A key function of the position will involve review of manufacturing batch records, analytical data, and associated documents within the Quality Assurance department and will also support general quality systems related to Good Manufacturing Practices (GMP) within the organization. The candidate will be expected to interact with multiple internal departments.

Responsibilities

• Interact with representatives from other departments, including QC and Analytical Development, to obtain the necessary information for review of documentation
• Review and approve analytical testing data and final reports from internal and external sources
• Assist with investigations and deviations, as appropriate
• Organization and control of project related documentation
• Perform release of controlled documents such as logbooks and other forms, as well as a final quality review on completed forms, weight set verifications, label reconciliations
• Scan and upload executed documents to the EDMS, properly categorize within the system, and route for verification/approval
• Maintain knowledge of current compliance expectations and regulations pertaining to drug development.
• Review and perform QA disposition of all incoming raw materials intended for GMP manufacturing, including proper labeling of packaging/containers (Released, Quarantine, Rejected) according to Arrowhead Quality Procedures
• Additional duties as assigned

Requirements:

• Bachelor's degree in a science field
• At least three years of experience working in a regulated environment with preference to quality assurance auditing and/or raw material experience
• Working knowledge of drug GMP regulations, as well as ICH/FDA guidance documents
• Competent knowledge of and ability to use Microsoft Word and Excel and Smartsheet
• Ability to follow company procedures, work instructions, and policies
• Work in a safe manner; properly handle materials and chemicals
• Excellent attention to detail and organizational skills
• Ability to multi-task and prioritize work tasks with minimal supervision
• Excellent interpersonal, verbal, and written communication skills

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
• Prior experience with use of an electronic document management system in a regulated environment