Quality Control Microbiologist

4 weeks ago


indianapolis, United States Harba Solutions Inc. Full time

Job Responsibilities:


  • Perform microbial testing on raw materials, in-process samples, finished products, and environmental monitoring samples.
  • Analyze test results, identify contaminants, and report findings according to company and regulatory standards.
  • Conduct bioburden, endotoxin, sterility, and other microbiological assays using established protocols.
  • Conduct environmental monitoring of manufacturing areas, including air, surface, and water testing, to ensure compliance with Good Manufacturing Practices (GMP).
  • Document, analyze, and report environmental monitoring results, and perform trending analysis to identify potential issues.
  • Develop and validate microbiological testing methods to ensure accuracy and reliability.
  • Maintain laboratory equipment and ensure calibration and maintenance are performed regularly.
  • Prepare and review Standard Operating Procedures (SOPs) for microbiological testing and ensure adherence to procedures.
  • Maintain accurate records of all tests conducted and results obtained.
  • Prepare detailed reports, including deviations and corrective actions, as required.
  • Assist in investigation and resolution of microbiological quality issues, including root cause analysis and CAPA.
  • Ensure all microbiological testing complies with GMP, GLP, and regulatory guidelines (FDA, EU, etc.).
  • Participate in audits and inspections by regulatory agencies and internal quality assurance.


Qualifications:


  • Bachelor’s or Master’s degree in Microbiology, Biology, or a related field.
  • 2+ years of experience in a QC microbiology role, preferably in a pharmaceutical, biotechnology, or similar regulated environment.
  • Proficient in microbial testing methods (e.g., bioburden, endotoxin, sterility).
  • Familiarity with regulatory guidelines (FDA, EMA) and GMP/GLP standards.
  • Experience with environmental monitoring programs and aseptic techniques.
  • Strong analytical and problem-solving skills.
  • Excellent communication and documentation skills.
  • Ability to work independently and as part of a team in a fast-paced environment.
  • Experience with laboratory information management systems (LIMS).
  • Knowledge of Quality Risk Management and understanding of CAPA processes.


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