Quality Assurance Professional
2 weeks ago
Arrowhead Pharmaceuticals is seeking a dedicated Quality Assurance Professional to join our team in Pasadena, CA. As a key member of our quality assurance department, you will be responsible for ensuring compliance with Good Clinical Practice (GCP) standards and regulations.
About the PositionThe ideal candidate will have a minimum of 5 years of experience in GCP, investigator site audits, and compliance. A strong background in authoring, reviewing, and managing controlled documents is also essential. In addition, the selected individual must possess excellent communication and problem-solving skills.
Key Responsibilities- Develop and maintain clinical quality study risk plans and updates in the Quality Management System
- Share risk plans and updates with functional QA leads
- Collect site metrics for the selection of investigator site audits
- Implement and update investigator site audit annual plans
- Participate in program and protocol team meetings as the QA representative
- A minimum of a bachelor's degree in a Science discipline
- A minimum of 5 years of relevant experience in GCP, investigator site audits, and compliance
- Experience administering deviation and/or CAPA processes
- Experience authoring, reviewing, and managing controlled documents
- Strong knowledge of GCP and Food & Drug Administration (FDA), European regulations, and ICH guidelines
We offer a competitive salary range of $125,000 - $145,000 per year, depending on experience. Additionally, we provide an excellent benefit package, including health insurance, retirement plan, and paid time off.
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Quality Assurance Specialist
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Clinical Quality Assurance Manager
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Construction Quality Control Specialist
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