Microbiology Tech II

Key Responsibilities

• Perform visual, dimensional, and functional inspections of purchased materials, components, and finished products.
• Carry out testing and inspections to ensure compliance with quality specifications and regulatory requirements.
• Record inspection and test results accurately.
• Identify and document non-conforming materials within the NCMR system.
• Propose improvements to quality policies, procedures, and inspection processes.
• Ensure compliance with FDA regulations, company quality standards, and regulatory requirements.
• Collaborate with cross-functional teams, suppliers, customers, and contractors.
• Perform environmental monitoring within cleanroom environments using aseptic techniques.
• Conduct viable air sampling, viable surface sampling, non-viable particulate monitoring, and compressed dry air sampling (preferred).
• Utilize LabVantage LIMS to document testing and monitoring activities.
• Follow Good Documentation Practices (GDP).
• Maintain laboratory records and microbiology documentation.
• Follow contamination control procedures and cleanroom requirements.
• Support microbiological investigations and corrective actions.

Required Qualifications

• Experience in Quality Inspection, Microbiology, Environmental Monitoring, or a related regulated manufacturing environment.
• Knowledge of aseptic techniques and cleanroom practices.
• Familiarity with viable and non-viable environmental monitoring.
• Understanding of quality systems, inspection processes, and regulatory compliance.
• Experience with Laboratory Information Management Systems (LIMS), preferably LabVantage.
• Strong documentation skills with Good Documentation Practices (GDP).
• Strong computer skills.
• Detail-oriented with excellent organizational and problem-solving abilities.
• Strong communication and teamwork skills.
• Ability to adapt to changing business needs.