Associate Engineer, Quality Assurance Engineering

2 weeks ago


Verona, Wisconsin, United States Arrowhead Pharmaceuticals Full time
Job Summary

Arrowhead Pharmaceuticals, Inc. is seeking a highly skilled Associate Engineer, Quality Assurance Engineering to support the development and maintenance of quality systems in our Quality Assurance department. As a key member of our team, you will be responsible for ensuring compliance with Good Manufacturing Practices (GMP) regulations and supporting the validation of systems and processes.

Key Responsibilities
  • Develop and maintain quality systems and procedures to ensure compliance with GMP regulations
  • Support the validation of systems and processes, including qualification and validation efforts
  • Review and approve system and process lifecycle documentation, including risk assessments and supporting validation documentation
  • Provide guidance and support for the issuance, review, and approval of internal deviations, change controls, and CAPAs
  • Support the development and implementation of periodic reviews for validated systems or processes
  • Review and approve internal and vendor-generated data and documentation in support of validation, qualification, and commissioning activities
  • Finalize the release of systems and instruments for use
  • Support the utilization of an electronic document management system (Veeva QualityDocs)
  • Perform quality reviews on completed forms, weight set verifications, and label reconciliations
  • Prepare documentation and provide support for internal and external audits
Requirements
  • At least 4 years of experience working on systems validation in an FDA-regulated environment, preferably in a quality assurance position
  • Working knowledge of drug GMP regulations (21CFR Parts 11, 210, 211, and EU GMPs, including Annex 11 and 15)
  • Competent knowledge of and ability to use Microsoft Word and Excel
  • Ability to follow company procedures, work instructions, and policies
  • 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
  • Work in a safe manner; properly handle materials and chemicals
Preferred Qualifications
  • A bachelor's degree, or higher, in a science field
  • Prior experience with the use of an electronic document management system in a regulated environment

Arrowhead Pharmaceuticals offers a competitive salary and an excellent benefit package. All applicants must have authorization to work in the US for a company.



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