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Seagen
Senior Quality Control AnalystSeagen • Bothell, United States
Senior Quality Control Analyst

Senior Quality Control Analyst

Seagen • Bothell, United States
30+ days ago
Salary
$94,000.00–$121,000.00 yearly
Job type
  • Full-time
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:

Performs routine and non-routine testing with expert proficiency and general QC laboratory work for the in-process support, release and/or stability of Seagen’s clinical development and/or commercial products in a GMP testing environment. Must be able to work weekends, off-shifts, and overtime as required. Holiday work may be required. Applicant must be willing and able to work reliably on a flexible schedule, Monday – Friday and some weekends, to meet the demands of the project.Principal Responsibilities:

  • Applying the principles of good manufacturing practices (GMP) on a daily basis

  • Performing sample testing for stability or release testing

  • Analyzing and compiling data and preparation of reports

  • Reviewing assays/data for compliance to specifications and reports abnormalities

  • Creating and revising standard operating procedures (SOPs) and other documents as needed

  • Identifying and leading continuous improvement projects

  • Supporting special projects for analytical problem solving

  • Participating in the qualification and validation of test methods

  • Troubleshooting laboratory or system anomalies

  • Authoring and owning deviations, CAPAs, and Change Controls

  • Method or system development and/or optimization

  • Training other personnel

  • Serving as SME for Test Methods or other areas of expertise

  • Providing oversight for programs, specific to job function (., Analytical Chemistry)

  • Representing QC in cross-functional teams

Required Qualifications:

  • Associate’s degree in a relevant field with 2 years of experience or a Bachelor's degree in a relevant field (in addition to 8+ years of relevant experience) or a Master’s degree in a relevant field (in addition to 5+ years of relevant experience)

  • Broad experience with Microsoft Office products

  • 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

  • Experienced in various analytical lab equipment (balances, CE/iCIEF, HPLC/UPLC, osmometers, pH meters, pipettes, plate readers, SoloVPE,

  • Experience authoring or revising SOPs

  • Familiarity with Change Controls

  • Participation in Laboratory Investigations

  • Ability to keep order of multiple projects/tasks

Preferred Qualifications:

  • 4+ years of experience working in a GMP laboratory

  • Participation in Laboratory or Out of Specification Investigations

The hiring pay range for this position is $94,000 - $121,000 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.

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Senior Quality Control Analyst • Bothell, United States

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