Quality Control Microbiologist

Responsibilities:

• Maintain operational compliance with U.S. and international regulatory agencies and guidelines (e.g., FDA, ISO, USP, cGMP, etc.).
• Conduct Sterility, Endotoxin, Particulates, and Bioburden testing on drug products, intermediates, and raw materials using aseptic techniques, following USP guidelines and internal SOPs.
• Execute Growth Promotion testing in line with USP methods for various microbiological media.
• Prepare and analyze Biological Indicators to support Validation and Qualification activities.
• Quantify microbial growth, subculture pure isolates, and document findings accurately.
• Enter and review data in Laboratory Management Systems (LIMS).
• Perform general laboratory housekeeping and routine maintenance of laboratory premises and equipment.
• Conduct in vivo biological performance testing to support product efficacy and quality according to USP and internal standard test methods.
• Collaborate with team members to ensure the timely and consistent completion of testing and other department objectives.
• Support laboratory investigations, root cause analyses, and assist in the implementation of corrective and preventative actions (CAPA).
• Adhere to safety protocols and maintain compliance with quality and site-specific operational guidelines.
• Participate in inventory management and ensure adequate stock of laboratory supplies.
• Assist with monthly equipment safety inspections.
• Help train less experienced technicians as needed.

Qualifications:

• Bachelor of Science in Microbiology, Biology, or relevant field of study.
• 3+ years of relevant experience in a laboratory or regulated environment.
• Experience working in a cGMP-regulated production or quality environment.
• Strong interpersonal, analytical, problem-solving, and decision-making skills.
• Excellent written and verbal communication skills.
• High attention to detail and strong organizational skills.
• Proficiency with computers and data entry systems.
• Flexibility, adaptability, and a commitment to teamwork.
• High level of energy with regular, consistent attendance.