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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BioTech FYI Center
http://biotech.fyicenter.com/