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
Work 3rd shift
• 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.
To apply for this job please visit pharmaboard.com.