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Employer provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries The Quality Control Microbiologist is an integral part of the team and performs quality activities in support of product production and releases. The QC Microbiologist performs a wide variety of activities to ensure compliance with applicable regulatory requirements by conducting testing, trending and reporting results.
Join our talented workforce, where a commitment to excellence and a customer focused attitude is everything. We pursue excellence because our work has the power to improve patients’ lives with the pharmaceuticals we develop and manufacture. Responsibilities:
• Perform microbiological testing (endotoxin, bioburden) for water
• Perform microbiological testing (endotoxin, sterility and bioburden) for raw materials, in-process materials, intermediates and final product
• Perform environmental monitoring of the clean rooms (under ISO and EU specifications)
• Read, trend and report environmental, personnel, in-process, raw material, finish product and water bioburden testing results.
• Perform microbial characterization (gram stain, catalase, oxidase, and couagulase tests)
• Prepare and send out samples for microbiological identification
• Maintain historical files on organisms found in classified areas; microbial identification and trending
• Perform line clear and line start verifications
• Inspection of media fills
• Perform other microbiological assays:
• Sterility ( including Biological Indicator testing)
• Growth promotion testing of all incoming media used in the microbiology
• Preservative Effectiveness testing
• Microbial Limits testing
• QC microbiological sample receipt for internal testing, login, processing, tracking, distribution of test results, and closure
• Initiate OOS/OT or Environmental Monitoring Excursion Investigations
• Provide Support of general QC Microbiology Laboratory activities
• Chart reading and changing
• Equipment cleaning and maintenance
• Maintaining supplies and inventory
• General laboratory housekeeping


Bachelor’s Degree in scientific discipline required; microbiology strongly preferred
• Industry experience in a GMP,GLP, or pharmaceutical clean room environment Preferences:
• Knowledgeable in FDA cGMPs (21 CFR 211); ISO 9001, 13485 and 17025 a plus.

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