Microbiology Lab Scientist (Med Tech)

Overview

Responsible for analyzing biological samples to detect, identify, and study microorganisms (bacteria and parasites). Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines. Performs routine sample preparation and analysis procedures. Transitions to more complex techniques/procedures and performs analysis throughout role tenure. Responsible for review and compilation of results and data comparison against SOP acceptance criteria, methodology, protocol, and product specifications.

Key Responsibilities/Essential Functions

• Perform microbiological testing on clinical trial patient samples (stool, urine, sputum)
• Culture and isolate microorganisms using appropriate media and techniques
• Identify organisms using biochemical tests, microscopy, molecular methods or automated systems
• Conduct antimicrobial susceptibility testing (AST)
• Maintain accurate lab records and document results in LIMS systems
• Ensure compliance with laboratory safety and quality standards (CLIA, CAP, GLP)
• Calibrate, maintain, and troubleshoot laboratory instruments
• Interpret and report test results to physicians, researchers, or stakeholders
• Participate in method development, validation, and quality control procedures
• Follow biosafety protocols and infection control procedures
• Trains on routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory procedures and guidelines
• Completes all laboratory documentation in clear and accurate language and according to SOP and GLPs
• Reviews and compiles results from assignments and makes initial determination on acceptability per SOP acceptance criteria
• Problem solves with assistance pertaining to extraction and/or instrumentation problems
• Performs work assignments accurately, and in a timely and safe manner
• Manages QC responsibilities with minimal/no supervisor input
• Communicates project status to project leader
• Builds an understanding of QA processes and manages responsibilities with decreasing supervisor or QA input

Required Skills & Competencies/Job Knowledge

• Strong understanding of microbiology principles (bacteriology and parasitology)
• Hands-on experience with aseptic technique, culture methods, microscopy, molecular/immunological diagnostics
• Knowledge of laboratory regulations and documentation practices
• Attention to detail and strong analytical skills
• Ability to work independently and in a team
• Problem-solving and troubleshooting ability
• Familiarity with lab software/LIMS systems
• Knowledge of routine operation, maintenance, and theory of analytical instrumentation, SOPs, and regulatory guidelines
• Knowledge of applicable regulatory authority, compendia and ICH guidelines
• Excellent manual dexterity skills
• Strong written and oral communication skills
• Exceptional time management and project management skills
• Capable of cross-training on sample preparation techniques with another laboratory group
• Thrives in a collaborative work environment

Education & Qualifications

• Bachelor's degree in Microbiology, Biology, Medical Laboratory Science, or related field (required)
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 0-2 years)
• Certification (Preferable, but not mandatory): ASCP (MLS/MT or M), AMT or equivalent