Qc Microbiologist

Position Title QC Microbiologist Department Quality Control Location Pharmaceutical Production Unit Reports To Quality Control Manager Microbiology Supervisor Job Summary The QC Microbiologist is responsible for ensuring the microbiological quality of pharmaceutical products by performing routine microbiological tests and analyses monitoring environmental conditions and maintaining adherence to GMP Good Manufacturing Practices and regulatory requirements The role involves identifying isolating and characterizing microorganisms performing microbiological validation and implementing corrective actions when necessary Key Responsibilities Microbiological Testing and Analysis Perform microbiological testing on raw materials in-process materials and finished products Conduct tests such as sterility testing endotoxin testing LAL bioburden testing and microbial limit testing Analyze results of microbiological testing and provide accurate reports Environmental Monitoring Monitor and assess microbiological quality in the production environment including air water surfaces and personnel Ensure that cleanroom and controlled environments meet the required microbiological standards Implement regular environmental monitoring programs and provide documentation of results Microbial Identification and Investigation Identify microorganisms through various techniques such as gram staining biochemical testing PCR or other molecular methods Investigate and report microbiological out-of-specification OOS results and deviations and provide recommendations for corrective actions Validation and Compliance Participate in microbiological method validation equipment qualification and requalification processes Ensure all microbiological testing complies with current cGMP current Good Manufacturing Practices and FDA WHO or other applicable regulatory standards Maintain accurate and up-to-date records of all microbiological tests and results Documentation and Reporting Prepare and review laboratory reports testing protocols and batch records for accuracy and compliance Ensure the timely completion of documentation for microbiological testing in accordance with standard operating procedures SOPs Training and Support Provide microbiological expertise and training to production staff ensuring the proper implementation of microbiological best practices Support troubleshooting of microbiological issues related to production processes Equipment and Inventory Management Ensure calibration and maintenance of microbiological testing equipment Maintain an inventory of microbiological reagents culture media and other supplies ensuring stock levels are adequate for testing needs Continuous Improvement Collaborate with cross-functional teams to improve microbiological processes enhance testing methods and optimize laboratory workflows Participate in audits and inspections and contribute to CAPA Corrective and Preventive Action processes as necessary Skills and Qualifications Education Bachelor s degree in Microbiology Biotechnology or a related field A Master s degree or relevant certifications in microbiology is a plus Experience Minimum of 2-4years of experience in microbiological testing and quality control in a pharmaceutical or related industry Technical Skills Proficient in microbiological techniques such as microbial identification sterility testing endotoxin testing and microbial limit tests Familiar with laboratory equipment and instruments used in microbiological testing e g incubators autoclaves laminar flow hoods etc Knowledge of microbiological safety and laboratory hygiene protocols Regulatory Knowledge Understanding of cGMP GLP and regulatory requirements such as FDA USP and ICH guidelines Familiarity with pharmaceutical industry standards and laboratory best practices Soft Skills Strong attention to detail and accuracy in testing and documentation Excellent problem-solving skills and the ability to perform investigative work Good communication and team collaboration skills Certifications Certification in microbiology or related fields is desirable e g ASQ PMP Job Type Full-time Pay 20 000 00 - 30 000 00 per month Benefits Cell phone reimbursement Internet reimbursement Leave encashment Experience QC Microbiologist 3 years Required Work Location In person