Job Description
Job Description
Job Title: Microbiologist
Experience Required: 3+ years
Job Description:
The Microbiologist is responsible for performing practical laboratory work including method development, method validation, and troubleshooting. This role involves taking ownership of the Quality Control (QC) portion of projects, conducting testing on raw materials, intermediates, and finished products, and supporting QC chemists with method technology transfer and project preparation to ensure timely and smooth project execution.
Key Accountabilities:
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Perform, analyze, and interpret QC and microbial limits testing according to USP and regulatory requirements for raw materials, finished products, and stability samples.
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Conduct environmental monitoring, including water sampling and testing.
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Perform microbiology methods and sampling techniques.
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Conduct investigations and implement CAPAs in response to laboratory findings.
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Manage change controls effectively.
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Manage and support microbiology projects from production or formulation development departments.
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Actively participate in customer and regulatory audits as the subject matter expert (SME) for the area.
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Develop and execute validation protocols for test methods and equipment qualification.
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Author and review SOPs and test methods related to microbiology.
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Ensure microbiological integrity of the environment, equipment, and facilities.
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Manage product testing based on internal and customer specifications.
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Manage third-party laboratory testing and reporting of data and environmental monitoring when necessary.
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Report on testing results, including Certificates of Analysis (CoAs).
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Maintain equipment, media, and sample logs as required.
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Ensure the microbiology lab is adequately supplied and maintained.
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Perform other responsibilities to support business needs as requested.
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Adhere to all defined Safety and Sustainability requirements and expectations and seek clarification when requirements are unknown or unclear.
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Promptly report Safety and Sustainability issues, problems, deficiencies, errors, incidents, or opportunities to management and correct when possible.
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Stop work when necessary to maintain safety.