Seagen

Quality Assurance Associate II

Technical Operations & Process Sciences - Bothell, United States

Description

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:

A Quality Assurance Associate II is responsible for supporting the operational life cycle of validated electronic systems and system users and providing front-line support for users by answering questions, providing training, investigating and resolving issues, and tracking issues to resolution. The position is responsible for program activities such as participating on functional teams and executing on defined and established procedures.

Principal Responsibilities:

• System support and administration of on-premises and hosted software solutions
• Support user requests to modify the system per routine admin tasks
• Support user issue identification and troubleshooting
• Assist with managing changes to supported systems
• Ensure software Service Level Agreements are met with end users
• Contribute to project milestones
• Revise or collaborate on program procedures
• Provide support during audits and inspections, as needed
• Participate on functional teams within the quality processes or programs
• Participate in continuous improvement activities
• Other duties as assigned

Required Qualifications:

• 2+ years in GMP operations, preferably in the pharmaceutical or biopharmaceutical 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.
• Experience with applicable software (e.g., Valgenesis, Veeva Vault Quality, Learning Management System, electronic Document Management System, data analytics, etc.).
• Excellent verbal and written communication skills
• Excellent interpersonal skills.
• Demonstrated problem solving skills and techniques commensurate with job level.
• Ability to manage day-to-day workload with minimal oversight.

Preferred Qualifications:

• Bachelors degree in relevant field; or Associate’s degree +2 years relevant experience
• Veeva Vault Quality
• Working knowledge of Valgenesis

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.

The hiring pay range for this position is $71,000 to $92,000 per year based on skills, education and experience relevant to the role. Other components of total compensation include a competitive equity grant at the time of hire (with additional annual grants, and grants upon promotion when applicable), and an annual bonus.

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: 02/10/2023