Quality Control Analyst III Analytical Testing

Company: Seattle Genetics
Location: Bothell
Posted on: January 25, 2023

Job Description:

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 Seagen Quality Control (QC) team is dedicated to supporting the release and stability testing of both our commercial and clinical stage programs. The QC Analyst II/III position is responsible for supporting the QC department by reviewing assays, equipment maintenance/verification, testing, and maintaining the lab in a GMP inspection ready state.

Principal Responsibilities:

• Applying the principles of good manufacturing practices (GMP) on a daily basis
• This person is responsible for reviewing assays/data for compliance to specifications and reports abnormalities within the QC laboratory
• This person works closely both within the QC organization as well as on a select number of cross-functional teams to ensure successful completion of group objectives
• Performing some sample testing for stability or release testing
• Creating and revising standard operating procedures (SOP's) and other documents as needed for change or improvement
• Supporting special projects for potency/analytical problem solving
• Troubleshooting laboratory or system anomalies
• Authoring and owning deviations, CAPAs and Change Controls
• Training other personnel
• Serving as SME for Test Methods or other areas of expertise Required Qualifications:
  • Proficient with Microsoft Applications (Word, Excel, Outlook, SharePoint, etc.)
  • Some experience with troubleshooting and/or an understanding of the listed equipment
  • Experience authoring or revising Standard Operating Procedures
  • Be highly organized with an attention to detail
  • Strong data interpretation/analytical skills
  • Strong troubleshooting skills
  • Strong knowledge of GMP compliance
  • Strong technical writing and communication skills
  • Experience authoring or revising Standard Operating Procedures Preferred Qualifications:
    • Experience working in a GMP regulated environment (GMP, GLP etc.).
    • Preferred experience with Empower Software Education:
      • Associates degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 4+ years of relevant experience) 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 visitwww.seagen.com.
        
        The hiring pay range for this position is $83,000.00 to $107,800.00 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.
        
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Keywords: Seattle Genetics, Seattle , Quality Control Analyst III Analytical Testing, Professions , Bothell, Washington