Senior Microbiologist

Department: Quality Systems
Reports to: QC Manager

The Senior Microbiologist is responsible for all microbiological testing of production materials; raw, in-process and finished goods; environmental monitoring under static and dynamic conditions and personnel monitoring under GMP conditions. Responsible for process and equipment validation (autoclave and depyrognenation oven) in cooperation with Engineering and R&D (New Product Sterility and LAL validation).

Specific Responsibilities

  • Development and validation of new or improved microbiological methods
  • Perform bioburden, sterility and endotoxin testing of raw materials, in-process samples, bulk and finished products and stability samples
  • Evaluating purified and deionized water for bioburden, endotoxin and TOC testing as per USP requirements
  • Writing and/or approving validation protocols, coordinating and/or performing validation and writing and/or approving validation reports
  • Establishing databases for microbiological and validation data
  • Verify work of technicians and assists in training
  • Review environmental condition of classified areas, maintain database for environmental results of clean room environment and summarize data for annual environmental report
  • Report and investigate Out of Specification (OOS) results and Environmental Control Notifications (ECN)
  • Investigate OOS results and ECNs; determine root cause, correct and implement corrective actions as appropriate
  • Coordinate for the calibration of equipment used in the laboratory; investigate any impact from the discovery of Out of Tolerance (OOT) equipment used in the lab
  • Ability to conduct various studies that support the validity of the QC Microbiology department including cleaning validations, disinfectant efficacy studies, residual disinfectant studies, growth promotion and media qualification
  • Other duties and projects as assigned

Experience, Knowledge, and Skills Required

  • Requires BS in microbiology, biology or related science
  • More than 5 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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