Position Summary
The Senior Quality Control Microbiology Analyst performs routine and non-routine microbiological testing of raw materials, in-process samples, finished goods, and stability samples in compliance with Good Manufacturing Practice (GMP) standards. This role involves reviewing batch documentation, conducting analytical investigations, writing technical reports, and supporting laboratory validation initiatives.
Key Responsibilities
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Routine & Technical Testing: Perform bioburden testing (membrane filtration and direct inoculation), bacterial endotoxin testing (Gel Clot and Kinetic methods), and sterility testing across raw materials, in-process, final product, water, and stability samples.
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Environmental & Utility Monitoring: Execute routine environmental monitoring of classified cleanrooms, analyze personnel and surface samples, perform growth promotion testing on culture media, and inspect media fill processes.
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Data Review & Compliance: Review raw testing data, batch release documentation, and calibration schedules. Conduct microorganism identifications (bacteria and mold) and ensure full compliance with relevant pharmacopeial standards (e.g., USP, EP).
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Investigations & Validation: Lead internal deviation and laboratory error investigations using standard risk analysis tools. Draft investigation reports, support process/method validation protocols, and document method validation results.
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Team & Operations Support: Assist with training junior staff, maintain equipment calibration tracking, and contribute to continuous improvement projects directed by laboratory leadership.
Qualifications & Experience
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Education: Bachelor's degree in Microbiology, Biology, or a related scientific discipline.
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Experience: 5-7 years of Quality Control Microbiology experience within a regulated life sciences or manufacturing environment.
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Regulatory & Technical Knowledge: Demonstrated proficiency with standard microbiology assays (Sterility, Bioburden, Endotoxin) and familiar with international regulatory guidelines (e.g., FDA, EMA, or equivalent regional health authorities).
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Core Competencies: Strong analytical problem-solving skills using formal root-cause analysis tools, technical writing capabilities, high attention to detail, and proficiency with standard office software.
