Quality Assurance Associate III

Summary:

This position will support the manufacturing and testing of commercial GMP materials with a focus on batch / lot review. The role reports into the Associate Director of European Quality Operations. The role sits within a growing Quality Operations team that is part of our expanding Global Center of Excellence focused on External Manufacturing and Testing.

Responsibilities:

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

Requirements:

• 3+ years' experience in the regulated pharmaceutical industry, with 1-2 years in QA or manufacturing
• Knowledge and experience with US/EU GMPs, ICH and other applicable international regulations
• Experience with the production and testing of pharmaceuticals (biologic or small molecules)
• Experience working with contract givers preferred
• Excellent communication skills and proven ability to work well with internal and external teams
• Experience with electronic documentation management systems preferred
• Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
• Fluency in English is a must

Education:

• Bachelor's degree in a scientific discipline (Chemistry, Biology, etc.) or similar

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics 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.