Seagen

Senior Quality Assurance Specialist

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!

Position Summary:

This position acts as advisor to management and customers on advanced technical work, that performs review of documents, records, and procedures supporting release of clinical and/or commercial GMP products. This role also participates with a full understanding of GMP operations, and strong ability to resolve a wide range of issues in creative ways.

Developing professional expertise, applies company policies and procedures to resolve a variety of work on problems of diverse scope where analysis of data requires evaluation of identifiable factors. Applies advanced technical principles, theories, and concepts and contributes to the development of new principles and concepts. Represents the organization on advanced projects and/or programs. Demonstrates strong judgment in selecting methods and techniques for obtaining solutions. Networks with internal and external personnel in own area of expertise. Contributes to the completion of specific programs and projects of complex nature, where independent action and a high degree of initiative are required in resolving problems and developing recommendations.

Can develop advanced technological ideas and guides their development into a final product. Works under consultative direction toward predetermined long-range goals and objectives and contributes to the design of those goals and objectives. Assignments are largely established in accordance with schedules and deliverables and are often self-initiated.

Principal Responsibilities:

• Perform MQA (Manufacturing Quality Assurance) role to support cGMP production and testing operations.
• 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 GMP and internal standards.
• Write and review Standard Operating Procedures.
• Review executed batch production records to ensure compliance with approved procedures and GMP expectations. Communicate and resolve discrepancies.
• Provide MQA oversight of in plant operations
• Review/approve Direct Material (i.e., raw material, other) testing to ensure data accuracy, conformance to specifications and documentation standards.
• Review receiving and testing documentation, label, and disposition Direct Materials (i.e., raw material, other).
• Compile or assist with managing lot files.
• 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:

• Knowledge of cGMP and applicable FDA/international regulations.
• Bachelor’s degree in a scientific discipline or equivalent with 10 years or more relevant industry experience in a cGMP/FDA regulated environment such as Manufacturing/QC or QA
• Direct experience with plant operations, pharmaceutical/biotechnology manufacturing, and analytical testing a plus
• Detail oriented team player with effective planning, organization, and execution skills
• Excellent communication skills with internal and external personnel essential
• Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems
• Strong computer skills (i.e., Word, Excel, Project, other)
• 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 working with clinical and commercial products and supporting regulatory inspections desired
• Experience with Lean-Six Sigma methodology preferred
• Experience with process validation activities (cleaning, viral, other)
• Ability to work weekend or holiday on an as needed basis
• Ability to gown into the plant, stand for prolonged time and lift up to 25 Pounds
• Ability to travel domestically and/or internationally up to 10% of time

Education:

• Typically requires a minimum of 10 years of related experience with a 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 $113,000 to $146,000 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.

To prevent the spread of COVID-19, and as an integral part of its public health and safety measures, Seagen requires that all newly-hired employees be fully vaccinated against COVID-19 before commencing employment, subject to reasonable accommodation and other requirements of applicable federal, state, and local law.

Apply:

Seagen

Seagen is an Equal Opportunity Employer

Submitted: 01/13/2023