QC Lab Systems Administrator

QC Lab Systems Administrator

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 .

The Role

The Technical BioPharma Manufacturing QC Systems Administrator SFD-TC will be responsible for providing System Administration support for the QC lab systems. This role will support the ongoing operations and maintenance lifecycle of QC instruments as the primary contact for System Administration and first line technical troubleshooting on lab instruments. The role will follow site and department procedures / SOPs, perform routine tasks and troubleshooting independently, and perform non-routine tasks and small projects with oversight as needed. The role will work collaboratively with the lab equipment System Owners, Business Owners, and users as well as Validation, IT, and Quality functions.

• Support and maintain QC Lab systems and equipment as the system administrator.
• Collaborate with cross-functional groups (QA, Validation, IT, etc.) to develop user requirements and configuration documents and manage vendor IQ / OQ of equipment
• Maintain system configuration documents and administration SOPs
• Author, execute, and / or review test plans and review IQ / OQ protocols as needed
• Perform first line troubleshooting for QC Lab Systems (e.g., user access issues, Windows issues, communication issues)
• Collaborate with vendors and other support teams (Automation, IT / IS, etc.) for advanced troubleshooting and configuration
• Perform business administration activities for other QC Lab software such as the Empower chromatography system and the LabX system which supports lab instruments like balances, pH meters and conductivity meters
• Support both internal and external audits as needed
• Own and manage change controls, non-conformances, and CAPAs for QC lab computer systems, as needed
• Troubleshoot issues, solve problems, and assist with investigations and deviations
• Ensures lab systems are compliant with Astellas Policies and SOPs and applicable regulations (e.g., 21 CFR part 11)