Quality Assurance Associate II/III

Summary:

The Seattle Genetics Quality Compliance team is dedicated to supporting the Quality Management System (QMS) for the protection of our patients. The QA Associate III position is responsible for assisting the compliance group as needed with associated documentation to assure vendor management and internal quality systems are consistent with established standards and in compliance with regulatory and industry expectations.

Responsibilities:

• Assist in internal audits; document, and track audit reports, observations/CAPAs
• Supporting external audits of CMOs and other service providers; via questionnaire preparation and review; document, and track reports and observations/CAPAs
• Supporting reporting including filing and tracking Annual product reviews
• Supporting reporting including filing and tracking Quality Agreements
• Revise Standard Operating Procedures as needed
• Participate as backroom, document runner support in regulatory inspections
• Assist in special projects as required, including archiving of documentation

Qualifications:

• Knowledge of cGMP and applicable FDA regulations
• Bachelor's degree in a scientific discipline or equivalent with 3+ years relevant industry experience in a cGMP/FDA regulated environment such as manufacturing/QC or QA
• Very detail oriented team player with effective planning, organization, and execution skills
• Excellent communication skills with internal and external personnel essential
• Experience with electronic systems such as Electronic Documentation Management System (EDMS), Quality Management System (QMS)
• Strong computer skills with Word and Excel
• Ability to work effectively and independently in a fast paced environment
• Innovative, proactive, and resourceful; committed to quality and continuous improvement
• Ability to anticipate and mitigate challenges
• Experience supporting regulatory inspections desired

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.