QC Scientist I Microbiology

QC Scientist I, Microbiology

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 Scientist, Microbiology will provide support to the AIRM MA-TC GMP Environmental Monitoring (EM) program, and microbial testing. QC Scientist will be responsible for supporting review of EM and lab test results, technical writing/projects, and training/coaching team members. This role is scheduled for Monday to Friday First shift (8 am to 5 pm) supporting GMP operations.

Role and Responsibilities

• Support day-to-day operations in QC Microbiology laboratories and the GMP facility.
• Reviews EM, lab test results, and documents for product testing, EM, and trend reports.
• Oversee the trending and reporting of environmental data.
• Be an SME/Trainer for microbial testing of media release, products testing for gram staining, pH, bioburden, bacterial endotoxin, and microbial identification.
• Be an SME for EM/lab assays and help with assay qualification, instrument troubleshooting, and procedure/report writing.
• Receive manufacturing samples for QC analysis, ship samples to the contract labs testing, review data for lot disposition.
• Author any non-conformance, deviations, and OOS investigations-work with the team to find a root cause and corrective actions for out of specification results.
• Support cleanroom qualification, gowning qualification, aseptic process qualification, and personnel monitoring for manufacturing activities.
• Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at contract labs and CMOs.
• Support QC equipment validation, maintenance, calibration, and QC laboratories scheduling and maintenance.
• Participate and own technical projects/documents for process improvement and implementation, experience with rapid assays (CCIT, Mycoplasma, and Sterility) is required.
• Represent QC in cross functional meetings and provide support/feedback for microbial quality/contamination control of the facility.
• Collaboratively develop and maintain the facilities contamination control strategy.