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. **Required Qualifications** - B.S. degree in Biology/Microbiology with 3+ years or MS with 0-2 years of relevant industry experience in a QC lab. - Demonstrated experience of aseptic techniques and common microbiological testing. - Must be able to gown into cleanrooms to perform EM testing. - Good documentation, data organization, detail oriented, and willingness to learn. - Must be capable of observing and adhering to lab safety standards and procedures. - Successfully performs routine work independently with minimal instructions. - Excels in a fast-paced team environment and completes assigned work in timely fashion. - Strong interpersonal skills, highly collaborative within a multi-disciplinary team and contributes to a supportive and positive work environment. - This role is scheduled to work during Day shift on Monday to Friday and flexibility may be required to support weekend GMP Operations. **Preferred Qualifications** - Prior experience in QC environment, knowledge of cGMPs and regulatory requirements pertaining to biotechnology and pharmaceutical industry. - Model our core values- Be Bold, Care Deeply, getting stuff done- while promoting the team culture and Compliance. **** **Location and Working Environment** - This role frequently requires long hours of sitting, standing and use of hands and regular motion to include bending, stooping, and lifting to 35lbs. - Requires gowning inside the cleanroom for extended periods of time. - Use of gloves and mask is required to prevent exposure to biohazards and viruses. - This is an on-site role working in a cGMP regulated manufacturing facility. **What awaits you at Astellas?** - Glo…