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Quality Control Specialist

2 months ago

Washington, Washington, D.C., United States Kelly Science, Engineering, Technology & Telecom Full time
Quality Control Scientist Job Description

Kelly Science & Clinical is seeking a highly skilled Quality Control Scientist to join our team at a biotechnology company in Seattle, WA. As a key member of our Quality Control team, you will be responsible for designing and executing various types of bioassays, supporting assay method development, validation, and transfer from R&D to Quality Control.

Key Responsibilities:

  • Develop and execute bioassays for in-process control and lot release, ensuring robust assays can be executed in Quality Control with GMP compliance documentation.
  • Conduct data reviews and trending, troubleshooting assays, and assisting lab members in ensuring high-quality experimental execution and data recording.
  • Handle and track BSL-2 material, author and review quality documents, and maintain laboratory equipment safely and efficiently.
  • Monitor and review stability data, coordinate sample analysis with on-site staff and third-party labs, and create analytical methods and procedures to contribute to continuous improvements in safety, quality, and efficiency.

Requirements:

  • PhD in biochemistry, enzymology, or a closely related scientific field plus 3 years of work experience in Quality Control/Development in a GMP compliance environment, or a bachelor's or master's degree in biochemistry or a related scientific field plus 5 years of work experience in Quality Control.
  • Experience developing highly reproducible custom immunoassays, PCR, ddPCR assays, enzyme assays, cell-based assays, and/or other types of essays.
  • Thorough understanding of the theory and practice of dPCR, cell-based binding potency, ELISA, and enzyme activity assays.
  • Experience setting up, optimizing, and deploying bioassays, applying statistical techniques in data analysis and data trending, and managing quality events.
  • Well-organized and detail-oriented with strong technical skills, excellent written and verbal communication skills, and proven ability to multitask.
  • Thorough knowledge of relevant cGxP, ISO 9001, and ICH requirements for document control and quality records.

What We Offer:

Kelly Science & Clinical offers a competitive salary range of $90,000-120,000 + equity, a dynamic work environment, and opportunities for professional growth and development.

How to Apply:

Apply now to join our team and take the next step in your career as a Quality Control Scientist. Our team of expert Science & Clinical recruiters will review your application and contact you if your skills and experience match our requirements.