Quality Control Analyst II, Microbiology
Do you want to be part of an inclusive team that works to develop innovative therapies for patients? Every day, we are driven to develop and deliver innovative and effective new medicines to patients and physicians. If you want to be part of this exciting work, you belong at Astellas!
Astellas Pharma Inc. is a pharmaceutical company conducting business in more than 70 countries around the world. We are committed to turning innovative science into medical solutions that bring value and hope to patients and their families. Keeping our focus on addressing unmet medical needs and conducting our business with ethics and integrity enables us to improve the health of people throughout the world. For more information on Astellas, please visit our website at www.astellas.com.
Astellas Institute for Regenerative Medicine (AIRM) is a wholly owned subsidiary of Astellas Pharma Inc and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.
AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell-based therapy research programs. AIRM is headquartered in Massachusetts.
Astellas is announcing a Quality Control Analyst II, Microbiology opportunity at their Astellas Institute for Regenerative Medicine (AIRM) site in Westborough, MA.
Purpose:
QC Analyst II, Microbiology will provide support to the AIRM GMP Environmental Monitoring (EM) program and microbial testing. QC Analyst II is responsible for perform/review, lab testing, technical documents, and training. This role is scheduled for Monday to Friday Day shift supporting GMP operations.
Essential Job 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 Incident reports for OOS 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.
Quantitative Dimensions:
The QC Analyst II, Microbiology routinely interacts with Manufacturing, QC Analytical, Quality Assurance, and management for microbiological testing and special projects.
Organizational Context:
The QC Analyst II Microbiology will typically report to the Associate Director, QC Microbiology. This role is expected to Model our Core Values and to demonstrate work performance as someone who exemplifies the culture we want to create; operates with transparency; is trusted; and supports the overall mission and vision of Astellas organization.