Job Description
Handle and distribute various samples received for microbiological analysis; maintain the related logbook.
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Maintain housekeeping and cleanliness of the Microbiology laboratory.
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Maintain inventory of microbiological media; perform media preparation, growth promotion tests, and reconciliation.
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Handle microbial cultures and perform inoculum preparation.
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Conduct water sampling and analysis as per the defined schedule; complete all associated records and reports.
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Perform sterility testing, bacterial endotoxin testing, antibiotic microbial assay, and bioburden testing of raw materials, in-process materials, and finished products.
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Carry out environmental monitoring and non-viable particle monitoring of microbiology cleanroom areas.
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Identify and log environmental monitoring isolates.
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Conduct disinfectant efficacy testing and microbial identification as per schedule and SOPs.
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Handle and test biological indicators.
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Perform Container Closure Integrity Testing (CCIT) of post-media fill units.
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Observe microbial plates and media fill units exposed in the manufacturing area.
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Report any out-of-specification (OOS) results or deviations to the department in-charge.
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Prepare standard operating procedures (SOPs) for microbiology-related activities.
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Coordinate with manufacturing, engineering, and QC teams for qualification, validation, and re-qualification activities.
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Participate in qualification activities of manufacturing and microbiology areas.
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Monitor and test compressed air, nitrogen gas, and perform personnel monitoring.
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Prepare material/product indents as per requirements.
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Initiate and review change controls, OOS investigations, and deviations.
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Complete self-training records and maintain documentation.
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Prepare laboratory study protocols.
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Review instrument logbooks, raw data of raw materials, packing materials, in-process samples, finished products, and water samples.
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Prepare Certificates of Analysis (COA).
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Follow good laboratory practices (GLP) and safety protocols.
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Perform water analysis and maintain daily water trend reports.
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Sample, test, and release raw materials, packing materials, miscellaneous materials, and in-process samples; maintain reserve samples as per SOP.
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Update instrument logbooks and record data in laboratory notebooks or relevant software.
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Plan and monitor cleaning, sterilization, and depyrogenation of glassware and microbiological items.
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Maintain status labels, logs, and reconciliation records for all laboratory items.
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Handle and maintain pure microbial cultures.
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Record daily area readings such as temperature, humidity, differential pressure, and cleaning logs.