Analysis Skills, Biology, Calibration, Cleaning Equipment, Clinical Support, Current Good Manufacturing Practice (cGMP), Disease, Environmental Monitoring, Equipment Maintenance/Repair, Equipment Validation, GMP (Good Manufacturing Practices), Healthcare, Immunology, Instrumentation, Laboratory Techniques, Manufacturing Analysis, Medical Products, Microbiology, Oncology, Ophthalmology, Preventative Maintenance, Product Testing, Production Support, Quality Control, Regulatory Compliance, Research & Development (R&D), Specimens/Samples, Testing, Urology, Women's Health, Writing Skills
Scientist Biopharma Manufacturing Quality Control Analyst II Microbiology SFD-TC, Quality Control - NC
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
This resource will be part of the Quality Control Microbiology team located at the Sanford TC in Sanford, NC, and will be responsible for environmental and utility sampling and testing, as well as additional lab functions as needed. This role will support QC testing for any products manufactured at the Sanford TC.
The Analyst II, Quality Control Microbiology will be responsible for implementing and executing microbiological testing in support of clinical and commercial products in compliance with GMP requirements. This role will also support testing for stability studies, method validation studies and equipment validation.
Role and Responsibilities
- Schedule Environmental and Utility Monitoring, ensuring all samples are collected as required
- Perform Environmental and Utility Monitoring
- Author/revise technical reports and laboratory procedures
- Author/review electronic database improvements
- Assist in data trending and summarization
- Participate in deviation and OOS investigations
- Perform plate reading and generate microbial isolates
- Receive, unpack and organize supplies for QC areas
- Perform routine cleaning, schedule equipment preventative maintenance, and organization of laboratory areas in accordance with cGMP
Other duties as required:
- Perform release, stability, and in-process testing supporting production activities. Testing includes, but is not limited to bioburden, endotoxin, pH/conductivity
- Perform growth promotion/media qualification
- Perform testing in support of method transfer/validations
- Participate in equipment qualification/validation studies
- Perform QC lab support activities including but not limited to sample management, reagent preparation, instrumentation maintenance, and instrument calibration
A
Astellas Pharma Inc
Astellas Pharma US, Inc., is a U.S. affiliate of Tokyo-based Astellas Pharma Inc. Located in Northbrook, Illinois, the company serves as the headquarters for the Americas and employs nearly 3,000 people. Astellas is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products.
Our commitment to changing tomorrow is measured not only by our focus on bringing innovative and effective new medicines to patients and physicians, but also by the importance we place on the impact we can make within the communities where we work and live. Astellas supports many causes and has created two initiatives to demonstrate our commitment: Changing Tomorrow Day, an annual, worldwide volunteer event, and Science WoRx, a nationwide mentoring program and online resource network for science teachers and their students.
2,500 to 4,999 employees
Biotechnology/Pharmaceuticals
https://www.astellas.com/us/