Quality Control Microbiologist
4 weeks ago
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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