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QC Analyst Bioassay Scientist

  1. North America, All US
Seattle
  1. Contract
Competitive
  1. Compliance / Quality Assurance
37478
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QC Analyst Bioassay Scientist -  US, Seattle - 8 Month Contract

Are you looking for your next contract, and fancy the opportunity to work in Seattle? Our client, a global biotechnology organisation, are recruiting for a QC Analyst Bioassay Scientist to join their team in the construction of their new biopharmaceutical production plant. This new build facility will be vital vehicle in helping our client continue global access to life changing therapeutics.

Responsibilities include:
  • Perform routine/non-routine QC testing using by techniques such as cell-based assays, ELISA, and qPCR.
  • Ensure timely and accurate completion of GMP documentation.
  • Collaborate with Analytical Development to generate and approve protocols, reports, and other technical documents required for the qualification and transfer of analytical methods.
  • Conduct laboratory investigations, deviations, OOS, change controls and CAPAs
  • Support equipment qualification (IQ, OQ, PQ).
  • Create, maintain, and revise SOPs, methods and associated documents.
  • Support all operations of the QC labs including the ordering supplies and maintaining laboratory equipment and lab spaces.
  • Support client audit/inspection readiness plans and interact with regulatory agencies during inspections on analytical related matters.
  • Participate in daily and weekly operation meetings
 Key requirements include:
  • BS in Biochemistry, molecular / cellular biology or chemistry or related field and extensive experience in GMP biopharmaceutical or biotechnology industry.
  • Knowledge of GMP regulations and experience with regulatory compliance inspections.
  • Hands on experience in the execution of potency and impurity methods (cell-based assays, immunoassays, and qPCR).
  • Laboratory experience with mammalian cell culture and cell banking.
  • Ability to adapt, work in a fast-paced environment, manage multiple projects and priorities at the same time.
  • Excellent oral/written and interpersonal communication skills; and a knowledge of Microsoft Office Suite (Excel, Word, PowerPoint).
If this role is of interest, please apply now!
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