Quality Assurance Associate III/ Specialist
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!
The QA Specialist is responsible for review of documents, records, and procedures supporting release of clinical and/or commercial GMP products. Position also participates with an understanding of GMP operations, and ability to resolve a wide range of issues in creative ways.
Contributes to the completion of specific programs and projects of complex nature, where independent action and a degree of initiative are required in resolving problems and developing recommendations.
Work is reviewed for accuracy and completeness. Can develop advanced technological ideas and guide their development into a final product. Works under consultative direction toward predetermined long-range goals and objectives and contributes to those goals and objectives. Assignments are established in accordance with schedules and deliverables and are often self-initiated.
- Review/approve deviations, CAPAs, and change controls. Monitor open quality system records to closure
- Review/approve executed batch production records to ensure compliance with approved procedures and cGMP expectations
- Compile and assist with managing lot files
- Review/approve controlled documents such as master batch production records, SOPs, test methods, specifications
- Review receiving and testing documentation, label, and disposition Direct Materials (i.e., raw material, other)
- Provide MQA (Manufacturing Quality Assurance) oversight of in plant operations
- Assist with reporting and/or presentation of department metrics
- Participate in audits: internal, external (vendor, partner), and regulatory inspections
- Ability to work weekend or holiday on an as needed basis
- Other duties as requested
- QA Associate III: 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
- QA Specialist: Bachelor’s degree in a scientific discipline or equivalent with 8+ 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
- Experience with clinical and commercial plant operations, pharmaceutical/biotechnology manufacturing, and analytical testing
- Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and inventory management systems
- Experience supporting audits and regulatory inspections a plus
- Experience with Lean-Six Sigma methodology a plus
- Detail oriented team player with effective planning, organization, and execution skills
- Excellent communication skills with internal and external personnel are essential
- Ability to work effectively at a fast pace with cross functional departments
- Innovative, proactive, and resourceful: committed to continuous improvement
- Ability to go into the plant, stand for a prolonged time and lift up to 25 Pounds
- Ability to travel domestically and/or internationally up to 10% of time
- Knowledge and experience with US/EU GMPs, ICH and other applicable international regulations
- Experience with the production facilities, utilities, and automation of pharmaceutical industry (biologic)
- Excellent communication skills and proven ability to work well with internal and external teams
- Ability to prioritize work and handle multiple assignments, while maintaining a high level of quality
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.
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.