Job Description

Department: Quality Control Microbiology | Position: Microbiologist

Job Summary

We are seeking a detail-oriented Microbiologist to support routine Quality Control Microbiology operations in a pharmaceutical manufacturing environment. This position will primarily perform environmental monitoring (EM), personnel monitoring (PM), and routine microbiology laboratory activities to support aseptic manufacturing, contamination control, and compliance with established procedures and applicable regulatory requirements. The successful candidate will work closely with Manufacturing, Quality Assurance, and other QC personnel to ensure timely, accurate, and complete execution and documentation of assigned activities.

Key Responsibilities

• Perform routine environmental monitoring in classified cleanroom areas, including viable air, surface, and settle plate sampling, in accordance with approved procedures and monitoring schedules.
• Perform personnel monitoring, including gown and glove sampling, and support aseptic gowning qualification and periodic requalification activities as assigned.
• Provide microbiological monitoring support during manufacturing operations, including cleanroom setup, aseptic processing, interventions, and post-operation activities, as required.
• Prepare, label, handle, incubate, read, and document microbiological samples and culture media; accurately record colony counts and observations within established timeframes.
• Perform routine laboratory activities such as media receipt and inventory, sample preparation, media growth promotion testing, microbial enumeration/bioburden, bacterial endotoxins, and sterility testing, as trained and assigned.
• Follow aseptic technique, cleanroom behavior, gowning practices, contamination-control measures, and laboratory safety requirements.
• Complete contemporaneous, accurate, and traceable records in accordance with Good Documentation Practices and data integrity requirements; review records for completeness before submission.
• Promptly communicate environmental or personnel monitoring excursions, atypical observations, equipment issues, and potential deviations to laboratory supervision; support investigations and corrective actions as assigned.
• Operate, clean, and perform routine checks of laboratory equipment; identify maintenance or calibration needs and maintain orderly, inspection-ready work areas.
• Maintain adequate supplies, media, and consumables; coordinate daily testing priorities with manufacturing schedules and the QC Microbiology team.
• Follow approved SOPs, GMP requirements, and applicable USP and FDA expectations; participate in training, continuous improvement activities, and inspection readiness.

Qualifications

Education: Bachelor's degree in Microbiology, Biology, or a related life science field required.

Experience: 1-3 years of relevant microbiology laboratory experience preferred; pharmaceutical, sterile manufacturing, or GMP-regulated experience strongly preferred.

Knowledge, Skills & Abilities

• Familiarity with environmental and personnel monitoring, aseptic technique, microbiological culture methods, and laboratory sample handling.
• Working knowledge of current GMP, Good Documentation Practices, data integrity principles, and applicable USP/FDA requirements.
• Ability to accurately follow written procedures, maintain complete records, recognize atypical results, and escalate issues promptly.
• Strong organizational skills, attention to detail, communication skills, and ability to work both independently and collaboratively.
• Ability to prioritize tasks and support time-sensitive manufacturing and laboratory schedules.

Work Environment & Expectations

Work requires routine entry into classified cleanroom environments while wearing required gowning and personal protective equipment, standing and walking for extended periods, and performing repetitive laboratory tasks. Flexibility to support scheduled manufacturing activities, including occasional off-shift or weekend work, may be required based on operational needs.

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