Quality Control Analyst II, Microbiology

TOPS Administration Bothell, Washington


Description

Summary: 

Performs with intermediate to advanced proficiency lab support activities and participates in basic routine and non-routine microbiological testing and general QC laboratory work in support 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 microbiological samples in accordance with standard operating procedures (SOPs)
  • Performs cleaning verification and/or validation testing support in accordance with standard operating procedures (SOPs) and aligned to industry requirements and best practices
  • Performs environmental monitoring and sampling of water and gas clean utilities
  • Performs analytical testing of in-process manufacturing samples, including bioburden and endotoxin
  • Creates and revises standard operating procedures (SOP’s) and other documents as needed
  • Performs troubleshooting of laboratory and/or system anomalies with limited guidance
  • Performs maintenance of QC lab equipment, procedures and systems
  • Conducts laboratory investigations, as needed
  • Authors and owns deviations, CAPAs and Change Controls
  • Identifies, participates and/or leads continuous improvement projects
  • Performs method or system development and/or optimization
  • Fully complies with company health and safety procedures and practices
  • Weekend, on-call and shift work may be required

 Required Qualifications:

  • 2+ years relevant laboratory experience (Analyst II)
  • Bachelor's degree in the biological sciences
  • Broad experience with Microsoft Office products
  • Experience with basic lab equipment (e.g. pH meters, balances, pipettes)

Preferred Qualifications:

  • General knowledge of aseptic technique and microbiology concepts
  • 2+ years of cGMP laboratory experience in the biopharmaceutical industry
  • 2+ years of microbiological testing experience

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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