Seagen

Associate III, Quality Systems

Description

Summary

The Quality Systems Associate III is responsible for supporting the development and maintenance of Seagen's Pharmaceutical Quality System (PQS) in accordance with internal standards, regulatory requirements, and applicable guidelines. The individual will support cross-functional project teams and will be accountable for ensuring risks within Seagen's PQS are consistently and effectively assessed, controlled, communicated, and reviewed. The individual must be able to interact with staff at various management levels.

Principal Responsibilities:

• Support the Quality Risk Management (QRM) program through improvements to documents, risk management tools and software, and training materials, as well as through executing on the program procedures, providing training, answering questions, and providing support for validation activities
• Support the Management Review/Metrics program, including updating guidance for metrics development, assisting departments with defining metrics, scheduling/participating in review meetings, preparing reports, and tracking metrics and action items
• Assist with other quality systems such as change management, data integrity, deviations, CAPA, and training, as needed, including processing records, sending notifications, collecting metrics, etc.
• Contribute to milestones associated with specific projects outside of routine program activities
• Write/revise, review, collaborate on, and approve program standard operating procedures, and ensure documents reflect current practices
• Provide support for audits and inspections, as needed
• Represent the Quality Programs group within the Quality Systems department on cross-functional teams or teams with external parties
• Own simple continuous improvement activities
• Other duties as assigned

Qualifications:

• 5+ years in GMP operations, preferably in the biopharmaceutical or the pharmaceutical industry
• Working knowledge of cGMP, including ability to understand and apply ICH guidance, regulatory guidance, and pharmaceutical organization guidance
• Working knowledge of current industry practices and standards
• Advanced expertise with Office 365, SharePoint, Power BI
• Experience with applicable software (e.g. Learning Management System, electronic Quality Management System, data analytics, etc.)
• Excellent written and oral communication skills
• Demonstrated problem-solving skills and techniques commensurate with job level
• Ability to manage routine and non-routine workload with minimal oversight

Education:

• Bachelor's degree in relevant field or equivalent experience; or 8+ years of relevant quality assurance, manufacturing, or quality control experience in the biotech or pharmaceutical industry

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.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 12/18/2020