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Microbiology Analyst

Job description

What does this job involve?

  • The Microbiology Analyst will be responsible for microbiological testing, method transfers and verification, sample and data management and equipment maintenance.
  • Perform analytical testing as a main priority with efficiency and accuracy
  • Responsible for planning and performing multiple, complex routine/ non-routine methods and procedures and a large variety of assays.
  • Report, evaluate, back-up/archive, trend and approve analytical data.
  • The Microbiology Analyst will troubleshoot, solve problems and communicate with stakeholders.
  • Initiate and/or implement changes in controlled documents.
  • Participate in audits, initiatives, and projects that may be departmental or organizational in scope.
  • Write protocols and perform assay validation and equipment qualification/verification.
  • Introduce new techniques to the lab, including method transfers, reports, validations and protocols.
  • Evaluate lab practices for compliance and operational excellence improvement on a continuous basis.

What should you have?

  • Bachelor’s degree in a science discipline with Biopharmaceutical QC experience in a microbiology lab
  • Experience with regulatory compliance in cGMP manufacturing and testing of pharmaceutical products
  • Experience in a wide variety of microbiological techniques, including but not limited to Bioburden, Endotoxin, Sterility (in an Isolator), Environmental Monitoring, Rapid Micro techniques, Microbial Identification, Media prep, Water Sampling.
  • Knowledge of related regulatory/industry considerations, compliance issues and/or scientific discovery
  • Experience in LIMS, Change Control, Trackwise, SAP and EDMQ an advantage

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