Seagen

Quality Assurance Associate III

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:

The successful candidate will perform review of documents, records and procedures supporting disposition of clinical or commercial cGMP products and participate in cGMP operations, as assigned. Works on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Contributes to the completion of specific programs and projects.

Demonstrates good judgment in selecting methods and techniques for obtaining solutions. Uses ability as a skilled specialist in accordance with company policies and procedures to complete complex tasks in creative and effective ways. Normally receives no instruction on day-to-day work, general instructions on new assignments. The ideal candidate will independently determine and develop an approach to solutions.

Principal Responsibilities:

• Perform QA role to support cGMP production and testing operations
• Provide QA in plant support for manufacturing operations
• Review executed batch production records to ensure compliance with approved procedures and cGMP expectations. Communicate and resolve discrepancies
• Compile or assist with managing lot files
• Review/Approve Direct Material (i.e., raw material, other) testing to ensure data accuracy, conformance to specifications and documentation standards. Disposition and status label materials post disposition
• Work with internal cross functional teams to resolve issues and identify corrective actions
• Review and Approve deviations, CAPA, and change controls. Monitor responsible open quality system records to closure
• Review cGMP Controlled Documents such as master batch production records, test methods, specifications and manage implementation of required changes to meet cGMP and internal standards
• Write and review Standard Operating Procedures as needed
• Assist with the reporting and/or presentation of department metrics
• Participate in audits: internal, external (vendor, partner), and regulatory inspections
• Other duties as requested

Qualifications:

• Bachelor’s degree in a scientific discipline or equivalent with 5 years or more relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing, QC or QA
• Knowledge of cGMP and applicable FDA/international regulations
• Direct experience with plant operations, pharmaceutical/biotechnology manufacturing and analytical testing a plus
• Experience working with clinical and/or commercial products
• Detail oriented team player with effective planning, organization, and execution skills
• Excellent communication skills with internal and external personnel essential
• Ability to work effectively at a fast pace with cross functional departments
• Innovative, proactive, and resourceful: committed to continuous improvement
• Ability to anticipate and mitigate challenges
• Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems
• Strong computer skills (i.e., Word, Excel)
• Ability to work weekends, evenings, holidays or overtime, as needed
• Ability to lift up to 25 Pounds and gown into manufacturing plant
• Ability to travel domestically and/or internationally up to 10% of time

Education:

• Bachelor’s degree in a scientific discipline or equivalent

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 $88,000 - $114,000 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 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: 10/27/2023