Quality Control Microbiologist

QC Microbiology SpecialistThe QC Microbiology Specialist is responsible for performing environmental monitoring, water testing, and microbiological analysis of raw materials and in-process samples. This role also involves executing validation and qualification protocols within a GMP-regulated environment, supporting sterile manufacturing operations.Key Responsibilities:Collaborate with manufacturing, technical, and quality teams to achieve site objectives related to safety, quality, delivery, and cost.Maintain a strong focus on safety, ensuring proper use of PPE, safety tools, and permits during sampling and laboratory activities. Uphold high laboratory housekeeping standards.Conduct environmental monitoring, water testing, and microbiological analyses, including endotoxin and bioburden testing, TOC/conductivity analysis, growth promotion, microbial identification, and biological indicator testing.Participate in and lead laboratory investigations using structured problem-solving methodologies.Develop laboratory procedures and contribute to broader site procedure development.Execute validation protocols, including process and method validation activities.Review laboratory data and documentation as required.Perform routine maintenance and upkeep of laboratory equipment.Develop and deliver GMP sterility assurance and microbiology awareness training to site personnel.Support bi-annual media fill studies to maintain manufacturing line qualification.Ensure accurate, complete, and timely documentation in compliance with cGMP requirements.Proactively identify and escalate any risks related to safety, quality, or performance.Skills and Knowledge:Proven experience in microbiological testing of sterile drug products, including environmental and utility monitoring.Experience in method validation.Strong understanding of regulatory requirements for microbiology and sterility assurance within cGMP manufacturing.Knowledge of Quality Risk Management principles.Education:Degree in Microbiology or a related discipline.Experience:Minimum of 5 years’ experience in a cGMP Quality Control Microbiology laboratory, including at least 2 years within the pharmaceutical industry.Work Environment and Physical Demands:This role involves significant physical activity due to sampling requirements, cleanroom support, and laboratory testing using isolators and similar equipment. Duties include regular use of hands, sitting, standing, walking, reaching, and occasionally crouching. The role may require lifting or moving items up to 5 kg. Appropriate protective and safety equipment must be worn as required.The position is typically day shift-based; however, flexibility may be required to work shifts depending on operational needs.Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.Travel:Occasional travel may be required (up to 10%), including national and international trips for training or equipment-related activities, with potential overnight stays.