Microbiology Analyst

Overview

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Are you a detail-oriented Microbiology Analyst with a passion for science and quality? Do you want to make a real difference in the pharmaceutical industry by helping deliver safe, life-saving products to patients? Join our Quality Control team, where your expertise will directly impact product quality, team performance, and the health of people around the world. This role offers opportunities to grow your skills, lead initiatives, and be a key contributor in a dynamic, science-driven environment.

• As a Microbiology Analyst in our laboratory, you will perform moderately to complex technical microbiological duties with precision, ensuring all testing meets regulatory standards and contributes to the release of high-quality products. Your responsibilities will include:
• Microbiological Testing:
  Conduct testing on in-process samples, raw materials, finished products, stability samples, and process validation samples using a range of techniques such as NAT, growth promotion, bioburden, microbial identification, LAL, I&E testing, sterility, and SAT assays. You will help ensure the safety, consistency, and reliability of all products released from the facility.
• Environmental Monitoring:
  Perform and trend environmental monitoring (EM) data to assess the cleanliness and integrity of production areas and laboratory spaces. Your work will support regulatory compliance and proactive identification of potential risks.
• Documentation & Reporting:
  Draft, review, and maintain high-quality laboratory documentation, including in-process data, external testing results, lab investigations, analytical reports, SOPs, technical reports, test plans, quarterly reports, and presentations. Your documentation will directly support product release and quality assurance initiatives.
• Method, Equipment, and Software Support:
  Participate in method, equipment, and software validation and transfer studies. Draft and execute protocols, analyze results, troubleshoot methods, and provide recommendations for improvements. You will support continuous improvement efforts and ensure laboratory processes are robust and reliable.
• Laboratory Operations & Support:
  Maintain laboratory housekeeping and operational excellence, including sample and reagent inventory management, consumables purchasing, equipment calibration and preventive maintenance, LFH/BSC cleaning, microbial , and general safety checks. Your efforts will help maintain a highly organized, safe, and efficient laboratory environment.
• Mentorship & Training:
  Share your expertise with team members by providing training and guidance on microbiological techniques, documentation practices, and laboratory procedures. You will play a key role in developing the skills of others and promoting a culture of scientific excellence.
• Data Analysis & Problem Solving:
  Apply statistical analysis to laboratory data, including hypothesis testing, trending, and regression analysis. Identify operational problems, propose solutions, and help implement improvements to enhance laboratory efficiency and accuracy.

• Bachelor’s degree in microbiology, Biological Sciences, or a related scientific field.
• 2+ years of laboratory experience in the pharmaceutical industry, including hands-on experience with microbiological assays, environmental monitoring, and utility testing.
• Strong aseptic technique and deep understanding of cGMP principles and quality control systems.
• Excellent written and verbal communication skills, organizational abilities, and attention to detail.
• Proficiency in Microsoft Office Suite;
  Trackwise experience is preferred.
• Experience with method, software, and equipment development or validation is a plus.
• Familiarity with Lean Six Sigma tools and methodologies such as 5S, Kanban, and Visual Factory elements is a plus.

Kedrion Biopharma Inc. participates in E-Verify and provides the federal government with Form I-9 information to confirm employment authorization. For more information, please contact the Department of Homeland Security.