LIMS System Administrator
7 days ago
About the Role
At Genmab, we're looking for a skilled LIMS system administrator to join our QC team. As our new LIMS system administrator for QC Lab, you will provide administrative and developmental support to all of our QC IT systems in our state-of-the-art GMP QC Laboratory.
The laboratory is responsible for supporting Genmab's innovative products by performing release and stability testing according to ICH guidelines. Systems are mainly the Labvantage Laboratory Information Management System (LIMS), the Laboratory Empower Chromatography Data System, and additional software used to control analytical equipment.
Key Responsibilities
- Responsible for maintaining the validated state of GxP systems.
- Liaison between System Users, Application Managers (IT), and QA.
- Drives business-related aspects of application design, testing, operations, and system improvements.
- Manage user access administration.
- Provide initial and ongoing training for users.
- Maintain data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
- Perform all aspects of QMS processes – Change Control, Deviations, CAPAs, writes, reviews, assesses, and/or approves change controls for software used in QC lab.
- Report achievements and escalate issues.
- Load and configure method templates in LIMS and Empower.
Requirements
- At least 5 years of documented professional experience working according to GMP in a QC setting.
- A thorough understanding of the detailed requirements for Software Validation and current trends.
- Experience with qualification of analytical instruments is desirable.
About You
- You are passionate about our purpose and genuinely care about our mission to transform the lives of patients through innovative cancer treatment.
- You bring rigor and excellence to all that you do. You are a fierce believer in our rooted-in-science approach to problem-solving.
- You are a generous collaborator who can work in teams with diverse backgrounds.
- You are determined to do and be your best and take pride in enabling the best work of others on the team.
- You are not afraid to grapple with the unknown and be innovative.
- You have experience working in a fast-growing, dynamic company (or a strong desire to).
- You work hard and are not afraid to have a little fun while you do so.
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