Scientific - Quality Control Scientist - Microbiology

Key Responsibilities

• Perform sterility testing, endotoxin testing, microbial identification, and routine microbiological testing on raw materials, in-process samples, and finished products.
• Carry out compendial tests including BacT assay, Endotoxin, and Mycoplasma assay.
• Support ongoing Environmental Monitoring Program (EMPQ), cleaning and disinfection, and improvement of aseptic control.
• Conduct environmental monitoring of manufacturing and laboratory areas.
• Execute trend analysis of EM and sterility data and write monitoring reports.
• Suggest/initiate resolution plans based on risks identified.
• Participate in investigations related to microbiological deviations, out-of-specification results, and non-conformances.
• Support CAPA, Change Control, and change actions.
• Collaborate with cross-functional teams, including Quality Assurance, Manufacturing, and Research & Development.
• Support the development and implementation of the site Microbial Control Strategy from incoming raw materials through final product release.
• Perform growth promotion as release testing.
• Analyze and interpret test results, documenting findings in compliance with SOPs and regulatory requirements.
• Ensure laboratory equipment is calibrated, maintained, and functioning properly.
• Perform monthly and quarterly cleaning of refrigerators, incubators, and BSCs.
• Stay current with industry trends, regulatory changes, and advancements in microbiological techniques.
• Support internal and external audits by providing data and documentation related to microbiological activities.
• Train and mentor other staff and new hires in microbiological techniques, laboratory procedures, and growth promotion.
• Maintain the QC microbiological lab, ordering reagents, and logging activities.

Required Qualifications

• Bachelor’s or master’s degree in microbiology, Biochemistry, Analytical Chemistry, Molecular Biology, or a related field.
• Minimum of 4-7 years of experience in a microbiology and/or bio-analytical laboratory, preferably in a pharmaceutical, biotechnology, or related industry. Alternatively, 10 years of relevant experience.
• Strong understanding of microbiological and bio-analytical techniques and principles, including aseptic techniques, ddPCR, Flow Cytometry, ELISA, Viability assay, and cell culture.
• Experience with method development and validation in a regulated environment.
• Familiarity with regulatory requirements (e.g., FDA, EMA) and cGMP guidelines.
• Proficiency in using laboratory equipment and software for data analysis.
• Excellent attention to detail and strong analytical skills.
• Ability to troubleshoot and solve technical problems related to microbiological and bio-analytical testing.
• Strong communication skills, both written and verbal.
• Ability to work independently and as part of a team in a fast-paced environment.
• Knowledge of statistical analysis and data interpretation.
• Familiarity with quality management systems and continuous improvement processes.