Quality Assurance Associate III External Quality

Seattle Genetics Bothell , WA 98021

Posted 2 months ago


The Seagen Quality Assurance team is dedicated to making the right product quality decisions for the protection of our patients. The QA Associate III position is responsible for reviewing batch production records and associated documentation to assure product quality is consistent with established standards and in compliance with regulatory and industry expectations.


  • Manage lot review activities for late phase and commercial GMP Intermediates, APIs, and Drug Products to ensure disposition timelines are met

  • Review and manage deviations from contractors related to manufacturing and testing

  • Review executed batch production records to ensure compliance with approved procedures, quality agreements and GMP expectations

  • Communicate and resolve discrepancies with CMOs

  • Compile and manage lot files

  • Enter data in to process monitoring system draft PQR sections

  • Participate in quality system improvements

  • Revise standard operating procedures and associated work instructions. Authoring SOPs is also possible under supervision

  • Monitoring local and global team meetings and project progress to ensure efficient and effective communication on project status and issues

  • Create and revise Standard Operating Procedures as needed

  • Participate in regulatory inspections


  • 5+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA

  • Working knowledge of cGMP, including ability to interpret and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance

  • Experience working with the production and testing of pharmaceuticals (biologic or small molecules)

  • Very detail-oriented team player with effective planning, organization, and execution skills

  • Excellent communication skills with internal and external personnel essential

  • Experience with electronic documentation management systems (EDMS)

  • Strong computer skills with Word and Excel

  • Ability to work effectively at a fast pace with cross functional departments

  • Innovative, proactive, and resourceful; committed to quality and continuous improvement

  • Ability to anticipate and mitigate challenges

  • Experience working with clinical and commercial products and supporting regulatory inspections desired

  • Occasional travel up to 10% of time


  • BS/BA or Master's Degree in a relevant field

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 visitwww.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.


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Quality Assurance Associate III External Quality

Seattle Genetics