Quality Control Analyst II - Chemistry

Global Quality Bothell, Washington


Description

Summary: 

Performs lab support activities and participate in basic routine and non-routine testing and general QC laboratory work for the release of raw materials of Seattle Genetics’ clinical development and/or commercial products in a GMP testing environment.

Principal Responsibilities:

  • Applies the principles of good manufacturing practices (GMP) in a QC laboratory on a daily basis
  • Conducts routine and non-routine analyses of raw material samples in accordance with standard operating procedures (SOPs) or compendial methods
  • Performs sampling and inspection of manufacturing aids
  • Supports analytical testing (HPLC, UV-Vis) of in-process manufacturing samples
  • Performs routine maintenance and troubleshooting of analytical laboratory instrumentation
  • Prepares buffers and test solutions used for QC testing
  • Creates and revises standard operating procedures (SOP’s), protocols, reports and other documents as needed
  • Utilizes Quality Systems to author and support Deviations, Change Controls, CAPAs
  • Contributes to the development, generation and implementation of raw material and manufacturing aid specifications for materials used in clinical and commercial manufacturing settings
  • Performs maintenance of QC lab equipment, procedures and systems
  • Develops and implements new laboratory systems and analysis techniques to support compendial testing
  • Trains other analysts in laboratory techniques
  • Works on individual projects independently with minimal supervision
  • Conducts laboratory investigations, as needed
  • Identifying and participating in continuous improvement projects
  • Fully comply with company health and safety procedures and practices
  • Weekend, on call, and shift work may be required

 Required Qualifications:

  • 2+ years relevant laboratory experience
  • Bachelor's degree in the biological or chemical sciences

Preferred Qualifications:

  • Knowledge and experience in regards to USP, EP and/or JP compendia and associated monograph testing
  • Proficient in Microsoft Office applications
  • 2+ years of cGMP laboratory experience in the biopharmaceutical industry
  • 2+ years of analytical testing experience, i.e. General Wet Chemistry Techniques, Titrations, HPLCs
  • Communicates Effectively, Nimble Learning

As the leading employer in our industry in the Pacific Northwest, Seattle Genetics 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 Seattle Genetics, please visit www.seattlegenetics.com.

Seattle Genetics 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.

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