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Quality Assurance Engineer

2 months ago


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

About Arrowhead Pharmaceuticals

Arrowhead Pharmaceuticals is a leading biopharmaceutical company that specializes in developing innovative medicines to treat complex diseases. Our team of experts is dedicated to harnessing the power of RNA interference to silence the genes that cause these diseases.

Job Summary

We are seeking a highly skilled Quality Assurance Engineer to join our team in Madison, WI. As a Quality Assurance Engineer, you will play a critical role in ensuring the quality and integrity of our products and processes. You will be responsible for developing and implementing quality systems, conducting audits and inspections, and providing guidance and support to our teams.

Key Responsibilities

  • Quality System Development and Implementation
    • Develop and maintain quality systems and procedures to ensure compliance with regulatory requirements
    • Implement and maintain quality management systems, including document control, training, and corrective action
  • Audit and Inspection
    • Conduct internal audits and inspections to ensure compliance with quality systems and procedures
    • Identify and report any deviations or non-compliances to management
  • Training and Support
    • Provide training and guidance to employees on quality systems and procedures
    • Support employees in understanding and implementing quality systems and procedures
  • Regulatory Compliance
    • Ensure compliance with regulatory requirements, including FDA regulations and EU GMPs
    • Stay up-to-date with changes in regulatory requirements and implement necessary changes to quality systems and procedures

Requirements

  • Education and Experience
    • Bachelor's degree in a science field, such as biology, chemistry, or pharmaceutical sciences
    • At least 4 years of experience in quality assurance or a related field
  • Skills and Knowledge
    • Working knowledge of quality systems and procedures, including document control, training, and corrective action
    • Strong understanding of regulatory requirements, including FDA regulations and EU GMPs
    • Excellent communication and interpersonal skills
    • Ability to work in a fast-paced environment and prioritize multiple tasks

Preferred Qualifications

  • Experience with Electronic Document Management Systems
    • Experience with electronic document management systems, such as Veeva QualityDocs
  • Advanced Degree
    • Masters or Ph.D. in a science field, such as biology, chemistry, or pharmaceutical sciences

What We Offer

Arrowhead Pharmaceuticals offers a competitive salary and benefits package, including medical, dental, and vision insurance, 401(k) matching, and paid time off. We are an equal opportunity employer and welcome applications from diverse candidates.