QC Lab IT Systems Administrator

1 week ago

Ballerup, Ballerup Kommune, Denmark Genmab Full time

At Genmab, we are dedicated to crafting extraordinary futures by developing innovative antibody therapies that significantly impact the lives of patients and the future of cancer treatment. Our team is characterized by a culture of care, transparency, and a commitment to making a difference, all rooted in scientific innovation.

We focus on the creation and advancement of unique antibody products aimed at enhancing the quality of life for cancer patients.

As the new Quality Control LIMS Administrator, you will play a vital role in providing both administrative and developmental support for our Quality Control IT systems within our state-of-the-art GMP QC Laboratory. This laboratory is essential for supporting Genmab's groundbreaking products through rigorous release and stability testing in accordance with ICH guidelines. The primary systems you will manage include the Labvantage Laboratory Information Management System (LIMS), the Empower Chromatography Data System, and various software used for controlling analytical instruments.

A significant aspect of this position involves overseeing the operational integrity of live IT systems. A comprehensive understanding of the LIMS and Empower systems utilized by Quality Control, along with their maintenance needs, is crucial. You will be responsible for managing the system's Standard Operating Procedures (SOPs) and Work Instructions (WIs), along with the associated training materials. This role requires strict adherence to regulatory standards while operating in compliance with current Good Manufacturing Practices (cGMP).

Key Responsibilities

  • Ensure the validated state of GxP systems is maintained effectively.
  • Act as a liaison among System Users, Application Managers (IT), and Quality Assurance.
  • Drive business-related aspects of application design, testing, operations, and enhancements.
  • Manage user access and administration.
  • Deliver initial and ongoing training for system users.
  • Uphold data integrity and ensure compliance with company SOPs, specifications, and cGMP regulations.
  • Oversee all elements of the Quality Management System processes, including Change Control, Deviations, and CAPAs, and manage documentation related to software changes in the QC lab.
  • Report accomplishments and escalate any issues as necessary.
  • Load and configure method templates within LIMS and Empower.

Qualifications

  • A minimum of 5 years of documented professional experience in a Quality Control environment adhering to GMP standards.
  • A solid understanding of Software Validation requirements and current industry trends.
  • Experience in the qualification of analytical instruments is advantageous.

About You

  • You are genuinely passionate about our mission to transform patient lives through innovative cancer therapies.
  • You approach your work with rigor and excellence, firmly believing in a science-based approach to problem-solving.
  • You are a collaborative team player, capable of working effectively with individuals from diverse backgrounds.
  • You are committed to achieving your best and take pride in enabling the success of your colleagues.
  • You embrace challenges and are open to innovative solutions.
  • You thrive in a fast-paced, dynamic environment and are eager to contribute.
  • You work diligently while also valuing a positive and enjoyable work atmosphere.

Work Environment

Genmab promotes an agile working environment to enhance employee work-life balance. Our offices are designed as open, community-oriented spaces that foster collaboration while being integrated with our cutting-edge laboratories. Whether working in our thoughtfully designed office spaces or remotely, we prioritize connection and innovation.

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