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Quality Control Microbiologist

Infotree Global Solutions
Frederick, MD Full Time
POSTED ON 3/7/2025
AVAILABLE BEFORE 6/6/2025

Job Description :

We are seeking a dedicated and experienced Quality Control Microbiologist to join our team. The ideal candidate will have hands-on experience with bioburden, endotoxin, and environmental testing, along with a strong background in other microbiology lab techniques. The candidate will play a vital role in ensuring the microbiological quality and safety of our products by adhering to regulatory standards and internal procedures.

Key Responsibilities :

  • Perform bioburden testing on raw materials, in-process materials, and finished products.
  • Conduct endotoxin (LAL) testing in accordance with USP and internal guidelines.
  • Ensure endotoxin levels are within acceptable limits for pharmaceutical and medical device products.
  • Monitor and track microbial contamination levels, including air, surface, and water samples.
  • Perform a variety of microbiological assays including, but not limited to, total viable count (TVC), sterility testing, and antimicrobial effectiveness testing.
  • Prepare reports in compliance with GMP (Good Manufacturing Practices) and regulatory guidelines.
  • Assist in the development and review of SOPs (Standard Operating Procedures) and work instructions.
  • Ensure proper calibration and maintenance of laboratory equipment.
  • Maintain laboratory inventory and ensure that all materials are stored appropriately.

Qualifications :

  • Bachelor’s degree in Microbiology, Biology, Biochemistry, or a related field.
  • Minimum of 1 years of experience in a microbiology lab, preferably in a Quality Control role.
  • Hands-on experience with bioburden, endotoxin (LAL), and environmental monitoring testing is preferred.
  • Familiarity with microbiological assays such as TVC, sterility testing, and antimicrobial testing is preferred.
  • Strong knowledge of microbiology laboratory techniques and best practices.
  • Experience with laboratory instrumentation, software, and data analysis.
  • Experience in a GMP-regulated environment.
  • Knowledge of regulatory standards (USP, EP, ICH guidelines).
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