Job Title:  Microbiologist

Supervisor: QC Manager

Summary of Primary Responsibilities:

In support of production activities, the Microbiologist is responsible for all microbiological testing of production specific items to include raw materials, in-process and finished goods. The Microbiologist performs environmental monitoring under static and dynamic conditions and personnel monitoring under cGMP conditions. The position provides assistance with process and equipment validation in cooperation with Engineering and R&D.

 Specific Responsibilities:

  •  Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples according to USP and SOP
  • Evaluate purified and deionized water for bioburden, endotoxin and TOC testing as per USP requirements
  • Maintain accurate logbooks and complete documentation as required
  • Verify work results of other technicians and assists in training as required
  • Report and investigate Out of Specification (OOS) results and Environmental Control Notifications (ECN); determine root cause and implement corrective actions as appropriate
  • Maintain database for environmental results of clean room environment and summarize data for annual environmental report
  • Participate in project teams and perform other duties as assigned

Job Complexity:

Works on complex problems requiring in-depth analysis and evaluations of factors, and on assignments that are required to be performed according to defined procedures and practices. Exercises considerable judgment and intiative within broadly defined practices and policies in selecting methods and techniques. Normally receives no instruction on routine work, general instructions on new assignments.

 Experience, Knowledge, and Skills Required:

  •  Bachelors degree in microbiology, biology or related science
  • 2-4 years experience in pharmaceutical industry with microbiological testing such as sterility/bioburden, new product validation, LAL testing and validation, microbial identification, gram staining, purified water testing as per USP (membrane filtration, endotoxin and TOC), bacteriostasis and growth promotion assay
  • Experience with GMP laboratory operations and FDA regulations
  • Experience in environmental monitoring of clean room, aseptic media fill evaluation
  • Excellent verbal and written communication skills
  • Proven ability to meet deadlines for testing and reporting
  • Proficient in the use of Microsoft Office Suite including PowerPoint

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