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US: Senior Microbiologist

Date: 28-Jan-2016
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Senior Microbiologist

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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