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QC Analyst I

This is a 12-month contract through Randstad at Takeda Pharmaceuticals in Lexington, MA.

Job Summary/Operations Involvement:
  • Primary duties of this position will focus on the daily lab operations and execution of testing to support manufacturing operations.
  • Testing may include but not limited to samples from drug substance and drug product, manufacturing, stability, raw materials and various protocol studies using test methods.
  • This position is expected to maintain operational and GMP readiness of the QC areas.

Specific QC Focus Area:
  • Biochemistry Focus: A280, SOLO A280, Compedia methods (pH. Moisture, OSMO, Appearance, Subvisible particles), Enzyme Activity assays, DNA, PCR, Free Thiol
  • HPLC focus: techniques such as SEC-HPLC, RP-HPLC, IEX, CE-SDS, iCE, enzyme activity, glycan mapping and peptide mapping

Education and Experience:
  • Essential: Bachelors degree and minimum of 0-2 years related experience
  • Desired: GMP knowledge, work experience
  • Knowledge: Limited use and/or application of basic principles, theories and concepts. Limited knowledge of industry practices and standards. Position requires critical thinking.
  • Key Skills: MS Office, LIMS, SAP, Trackwise, EDMS, Compliance and strong science understanding