Seagen is a global, multi-product biotechnology company dedicated to developing and commercializing transformative cancer medicines. As the industry leader in antibody-drug conjugate (ADC) technology, we pioneered a new generation in the science of harnessing antibodies to deliver cell-killing agents directly to cancer cells. Seagen’s dedication to improving the lives of cancer patients goes beyond science, and we believe that every employee has a role in contributing to this mission. By working together with a shared dedication and diverse perspectives, we are able to reach our full potential and make a real difference in the world. Seagen is a fast-growing company and has an abundance of opportunities available for you to grow your career. Put your passion to work at Seagen and join us!

Summary:

The Seagen Quality Operations team is dedicated to making the right product quality decisions for the protection of our patients. The QA Associate III position is responsible for department administration of ERP electronic systems, project management support, and document delivery to third parties, such as CMOs and partners.

Principal Responsibilities:

• Quality Operations support for ERP electronic systems
• Responsible for electronic system data entry as it relates to Quality Operations processes
• Generate monthly reports for Quality Operations processes and metrics
• Partner with Quality System team for development and optimization of electronic forms and processes, specific to Quality Operations
• Design and create job aids, course materials, and computer-based training for electronic Quality Operations system processes
• Deliver system training to end users
• Support Quality Hold Assessments for product complaints and expired materials
• Responsible for material quarantine process
• May support the following Quality Operations activities:
  • Participate in internal audits; write audit reports and follow up on observations/CAPAs
  • Assist with reporting and presentation of department metrics including Quarterly reports and Annual product reviews
  • Create and revise Standard Operating Procedures
  • Regulatory inspection support

Required Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent with 5+ years relevant industry experience in a cGMP/FDA regulated environment
• Knowledge of cGMP and applicable FDA regulations

Preferred Qualifications:

• Experience with Enterprise Resource Planning (ERP) systems and Electronic Documentation Management Systems (EDMS)
• Strong computer skills with Word and Excel

As the leading employer in our industry in the Pacific Northwest, Seagen is proud to offer a competitive total compensation package as well as a comprehensive benefits program designed to support the whole lives of our employees and their families. Benefits include medical, vision and dental coverage, group and supplemental life insurance, 401(k) with company match, tuition reimbursement, relocation assistance and much more. To learn more about Seagen, please visit www.seagen.com.

Seagen is an equal opportunity employer. All qualified applications will receive consideration for employment without regard to race, age, gender identity, sexual orientation, color, religion, sex, marital status, national origin, protected veteran status, disability status, or any other status protected by federal, state, or local law.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

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