QA Labs Scientist II

Key Responsibilities

• Perform sampling and analysis of water systems, in-process materials, pre-sterile products, and environmental monitoring data
• Determine compliance of microbiological data with established specifications
• Conduct organism identification and perform media preparation and quality control testing
• Initiate and support laboratory and non-conformance investigations, including root cause analysis and documentation
• Review, trend, and report microbiological and sterilization data
• Ensure compliance with GMP, GLP, FDA, and ISO standards
• Execute sterilizer qualifications and support equipment validation activities
• Participate in test method validation and other qualification-related projects
• Support troubleshooting, calibration, and maintenance of laboratory equipment
• Write and revise SOPs, protocols, technical reports, and investigation summaries
• Identify process improvement opportunities and recommend corrective actions
• Maintain accurate records in LIMS and ensure proper documentation practices
• Provide technical guidance and review work of junior staff
• Train laboratory personnel on microbiology procedures and best practices
• Collaborate cross-functionally with manufacturing, QA, and other teams
• Support environmental, health, and safety initiatives and departmental objectives
• Participate in special projects and perform additional duties as assigned

Qualifications

• Bachelor’s degree in Microbiology, Chemistry, or related field
• Minimum of 5 years of experience in microbiological testing and quality assurance
• Experience with sterility testing, environmental monitoring, and equipment validation
• Strong analytical skills and ability to troubleshoot complex issues
• Excellent communication and collaboration skills
• Knowledge of GMP, GLP, FDA, and ISO regulations