QA Specialist Supply Chain Quality

Technical Operations & Process Sciences Bothell, United States


Description

Position at Seagen

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 QA Specialist, Supply Chain Quality is responsible for providing quality oversight of shipping and materials management operations.  The QA Specialist partners with the Global Logistics, QC and Product Supply for transportation of clinical and commercial products across manufacturing stages, up to the final distribution service providers.  In addition, the QA specialist provides quality oversight of clinical distribution shipping events, including temperature excursions. This QA specialist participates in improvement projects for supply chain quality processes and partners with cross functional teams to develop programs and strategies to ensure a safe and high quality supply chain.  
 
Principal Responsibilities: 

  • Perform quality review and approval of routine shipping requests 
  • Review and approve temperature excursions and deviations that occur during shipment 
  • Approve transportation lanes 
  • Perform Quality review of shipping qualification 
  • Support logistic supplier qualification 
  • Support customers and answer complex questions supporting a range of projects 
  • Assess and approve change requests, deviations and CAPA 
  • Create, Review and Approve SOPs 
  • Represent Supply Chain Quality on cross-functional or external teams  
  • Develop new business processes as part of a team 
  • Process complex records that may involve external parties 
  • Assess business processes for team and identify opportunities for continuous improvement to drive efficiency, scalability, and risk reduction 
  • Influence cross-functional teams to meet compliance and business needs 
  • Acts independently to determine methods and procedures on new assignments.  
  • Participate in Regulatory inspections 

Required Qualifications:  

  • BS/BA in relevant field 
  • Minimum 8 years of experience in the pharmaceutical industry 
  • Knowledge of GMP, GDP and other applicable regulations applicable to US and international regulatory agencies 
  • Experience with temperature-controlled logistics  
  • In depth knowledge and experience with quality systems, corrective action and preventative action system, risk management, FMEA and other key tools for managing quality performance 
  • Knowledge of validation (shipping, equipment, facilities).  
  • Experience in regulatory inspections  

Preferred Qualifications: 

  • Experience with quality management systems (QMS), electronic documentation management systems (EDMS) and ERP systems 
  • Must be capable of assessing compliance to quality requirements using sound judgement and decision-making skills  
  • Excellent verbal and technical written communication skills, excellent interpersonal skills, and negotiation skills are essential  
  • Innovative, proactive, and resourceful; committed to Quality and continuous improvement  

 

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. 


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