Microbiologist 2

Position Summary

This role is responsible for being a subject matter expert (SME) on the methodologies of the testing being completed in the Microbiology Lab. This will require review of samples to ensure testing is performed according to provided work instruction. Fulfill microbiology role supporting new product development and other production sterilization activities. Lead investigations and provide technical support for non-conforming events and CAPA related to microbiology.

Principal Responsibilities

•    Perform and participate in development of product validations to adopt into test procedures
•    Execute routine Bacterial Endotoxin Tests and product bioburden tests
•    Execute media growth promotion testing and Gram staining
•    Lead nonconformance investigations
•    Maintain stock of lab supplies 
•    Review and approve test results generated by the Microbiology Lab according to good documentation practices
•    Assist in training junior microbiologists in validated test methods
•    Execute testing to support sterilization cycle revalidations and product change assessments
•    Supports as an SME for audits
•    Serve as microbiology member on product development teams 
•    May perform additional tasks, as assigned
 

Education / Experience Requirements

•    Bachelor’s Degree required in a scientific discipline
•    Minimum 2 years’ experience with medical device microbiology laboratory
•    Laboratory experience in bioburden, bacterial endotoxin testing, and/or reprocessing of reusable devices
 

Specialized Skills / Other Requirements

•    Manage workload autonomously and clearly communicate status
•    Familiarity of quality management system (QMS) structure and good documentation practices (GDP) 
•    Thorough understanding of at least one discipline within microbiology
•    Previous experience in a laboratory environment
•    Analytical ability to troubleshoot and investigate laboratory errors
•    Thorough understanding of basic laboratory requirements - including aseptic technique
•    Strong computer literacy
•    Proficient in technical report writing and review
•    Ability to define, organize, and manage individual tasks
•    Effective verbal and written communication
•    Ability to coordinate and execute activities involving multiple internal and external functions
•    Interpersonal skills; working in a team and as an individual contributor
•    Foster a positive culture of growth, collaboration, and achievement across the organization
 

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