Quality Control Microbiology Analyst at Agilent… · US-CO-Fre…

Summary: Agilent Technologies is a leading company in the biopharma industry, dedicated to advancing the next frontier of medicine. They are seeking a Quality Control Microbiology Analyst to support product release, stability testing, and environmental monitoring while ensuring compliance with regulatory standards. Responsibilities: - Conduct routine and non-routine microbiological and analytical testing in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMP) - Perform testing for Active Pharmaceutical Ingredients (APIs), final drug products, and in-process samples - Review and interpret data to ensure compliance with product specifications; troubleshoot and escalate abnormalities as necessary - Conduct environmental monitoring, cleaning verification, and stability testing - Ensure laboratory equipment is functioning properly and initiate corrective actions as needed - Maintain thorough and accurate documentation following Good Documentation Practices (GDP) - Communicate effectively with project managers and internal stakeholders regarding test results, timelines, and any issues - Participate in the continuous improvement of laboratory processes, procedures, and quality systems - Collaborate cross-functionally to meet project timelines and operational goals Required Qualifications: - Secondary Education with QC experience - Knowledge of analytical equipment and instrumentation Preferred Qualifications: - Bachelor's of Science (Microbiology, Life Sciences, or related field) - One year of experience in a Quality Control laboratory setting, preferably in the pharmaceutical or biotechnology industry - Knowledge of cGMP guidelines as well as international regulations - Knowledge of FDA regulations and guidelines - Personal leadership skills and fosters working in a team environment - Knowledge of and skills in using computer software and hardware applications, including Microsoft Word and Excel - Familiarity with a wide range of microbiological and analytical techniques below is preferred: Bacterial Endotoxin Testing (LAL Analysis), Bioburden Testing (Membrane Filtration), Total Organic Carbon (TOC) Testing, Compressed Gas Monitoring, Environmental Monitoring, UV Analysis, USP <61> testing Required Skills: Quality Control experience, cGMP, Analytical techniques Important Skills: Bachelor’s in Microbiology, FDA regulations knowledge Nice-to-Have Skills: Microsoft Word, Microsoft Excel, Personal leadership skills Benefits: Bonus, Stock, Benefits