Senior Quality Control Specialist

1 day ago


Cambridge, Massachusetts, United States Garuda Therapeutics Full time

We are seeking a highly skilled Quality Control professional to join our team at Garuda Therapeutics. This critical role will be based in our Cambridge, MA site, with occasional travel to our Watertown, MA GMP facility.

Key Responsibilities:

  • Support the development and implementation of quality control methods and procedures in accordance with ICH guidelines.
  • Conduct hands-on testing, including flow cytometry, ddPCR, cell count and viability, endotoxin and cell-based assays, potency assays, and extensive cell culture.
  • Collaborate with Analytical Development to transfer methods from development to QC Lab for GMP release assays.
  • Develop and write stability protocols with QC release methods in GMP laboratories.
  • Manage reference control development and material management for QC Lab, including QC laboratory records, reports, logs, and data.
  • Support sample management with internal and external partners (contract laboratories and suppliers).
  • Author quality systems records, such as SOPs, deviations, lab investigations, change controls, CAPAs, validation reports, etc.
  • Develop and review Environmental Monitoring Program documents.
  • Review and approve methods and procedures to ensure compliance with Garuda policies and procedures, regulatory guidelines, and current industry standards.

Requirements:

  • BS/MS degree in a relevant field is required.
  • 5+ years of experience in a GMP Quality Control function within a fast-paced biotech/pharma organization, including hands-on experience with aseptic techniques.
  • Experience with analytical test methods used for cell/gene therapy (e.g., flow cytometry, PCR) is required.
  • Prior experience with genome sequencing assays is preferred.
  • Previous experience with experiment design and execution to support method lifecycle.
  • Experience with Environmental Monitoring and microbiological testing is preferred.
  • Strong analytical skills and ability to troubleshoot and investigate issues from the testing.
  • Critical thinker with the ability to exert influence diplomatically while partnering across functions.
  • Handle issues appropriately and with a sense of urgency.
  • Possesses a positive, can-do attitude and creatively solves problems.


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