Quality Control Microbiology Analyst

Job Description

The world's most revolutionary biopharma companies are partnering with Agilent Technologies to advance the next frontier of medicine. Agilent continues to invest in capacity and expansion of its Colorado operations. Join our team of professionals dedicated to the development and commercialization of nucleic acid therapeutics for life changing, lifesaving medicines.

We are seeking a detail-oriented and experienced Quality Control Microbiology Analyst to join our growing Quality team. In this role, you will support product release, stability testing, environmental monitoring, and cleaning verification activities under cGMP and GLP conditions. You’ll play a key part in ensuring the quality and safety of pharmaceutical products while maintaining strict compliance with FDA, ICH, and international regulatory standards.

Key Responsibilities

• Conduct routine and non-routine microbiological and analytical testing in accordance with Standard Operating Procedures (SOPs) and current Good Manufacturing Practices (cGMPs)
• 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

Wednesday-Saturday Shift. 9a.m.-7p.m.

Qualifications

Required:

• Secondary Education with QC experience
• Knowledge of analytical equipment and instrumentation

Desired:

• 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