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Microbiology Quality & Sterility Assurance Scientist

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Job Function:
Quality

Job Sub Function:
R&D/Scientific Quality

Job Category:
Professional

All Job Posting Locations:
Warsaw, Indiana, United States of America

Job Description:

Depuy Synthes a member of the Johnson & Johnson Family of Companies is currently recruiting for a Microbiology Quality & Sterility Assurance Scientist! This position will be located in Warsaw, IN.

Position Summary

The Laboratory Technician is responsible for performing microbiological, environmental monitoring, and analytical testing activities that support medical device development, manufacturing, contamination control, and validation programs.

The position operates in a regulated laboratory environment and performs testing in accordance with approved procedures, protocols, work instructions, and applicable regulatory requirements.

The Laboratory Technician will conduct microbiological analyses, prepare laboratory media and reagents, support reusable device validation studies, perform equipment maintenance activities, and maintain accurate laboratory documentation while ensuring compliance with ISO 13485 quality system requirements.

Essential Responsibilities

Microbiological Testing

Perform routine microbiological testing including:


* Product bioburden testing


* Sterility testing


* Bacterial endotoxin testing


* Microbial water testing


* Compressed air microbiological testing


* Environmental monitoring sample processing


* Microbial limits testing, as applicable

Environmental Monitoring

Support the laboratory environmental monitoring program by performing:


* Viable air sampling


* Surface monitoring


* Personnel monitoring


* Non-viable particulate monitoring


* Cleanroom monitoring activities


* Environmental sample incubation and analysis


* Trending data collection and reporting support

Microbial Identification & Characterization

Perform microbiological identification activities including:


* MALDI-TOF microbial identification


* Gram staining


* Colony morphology characterization


* Pure culture isolation


* Culture maintenance and preservation


* Investigation ...




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