Quality Control Analyst

Quality Control Analyst Microbiology MA-TC

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

QC Analyst, Microbiology will provide support to the AIRM GMP Environmental Monitoring (EM) program and microbial testing. This role is responsible for performing and reviewing laboratory testing, developing and managing technical documents, and conducting training. This role is scheduled for Monday to Friday Day shift supporting GMP operations.

Role and Responsibilities

• Attire gowning for Grade B/A manufacturing areas and collect EM samples for viable air, non-viable particulates, and surface viable samples.
• Perform QC testing of samples for bioburden, microbial identification, growth promotion, and Endotoxin analysis.
• Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
• Read and Review routine EM plates, lab testing data, logbooks, and documents for product release and trend reports.
• Understand and follow aseptic behavior, good laboratory and manufacturing practices, and documentation.
• Help with assay/instrument qualification, troubleshooting, and procedure/report writing.
• Author/update laboratory procedures, protocols, and help in EM data trend reports.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Initiate investigations results and work with the team to find a root cause and corrective actions.
• Perform QC lab support activities like lab set up, housekeeping, instrumentation maintenance, and coordinate instrument calibration.