QC Microbiology Associate I

QC Microbiology Associate I

About Astellas

Astellas is a global life sciences company committed to turning innovative science into VALUE for patients. We provide transformative therapies in disease areas that include oncology, ophthalmology, urology, immunology and women's health. Through our research and development programs, we are pioneering new healthcare solutions for diseases with high unmet medical need. Learn more at Astellas.com.

Are you driven to make a real difference in the lives of patients?

We're seeking passionate individuals who thrive in dynamic environments, embrace new ideas, and aren't afraid to take intelligent risks. People who act with unwavering integrity and are deeply committed to making a tangible impact.

Purpose & Scope

The QC Microbiology Associate I provides direct support to GMP manufacturing operations through execution of Environmental Monitoring (EM), cleanroom qualification, personnel monitoring, and contamination control activities. This role spends the majority of time in classified cleanroom environments performing routine monitoring and sampling activities to support facility and product quality.

Role and Responsibilities

• Perform routine Environmental Monitoring sampling in Grade A/B/C/D manufacturing environments.
• Collect viable air, non-viable particle, surface, and personnel monitoring samples in accordance with approved procedures.
• Gown into classified cleanroom environments and demonstrate appropriate aseptic behaviors while supporting manufacturing operations.
• Support microbiological testing activities including bioburden, growth promotion, microbial identification, pH, Gram staining, and endotoxin testing.
• Receive, log, label, and process samples in accordance with approved procedures.
• Support laboratory housekeeping, inventory management, and equipment cleaning.
• Follow aseptic technique, cleanroom behavior requirements, laboratory safety procedures, and cGMP regulations.
• Participate in training programs and qualification activities to develop microbiology laboratory competencies.
• Support cleanroom qualification, personnel monitoring, and gowning qualification activities as assigned.
• Escalate environmental excursions, abnormal observations, equipment issues, and documentation errors.
• Participate in continuous improvement initiatives and special projects as assigned