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Urgent! IT System Administrator for QC Lab Position in Ballerup - Genmab

IT System Administrator for QC Lab



Job description

The Role

and Department

Our QC lab is growing in activities and looking to recruit a IT System Administrator to join our team onsite in Ballerup.

As IT system administrator at Genmab, you will provide administrative and developmental support to all of our QC IT systems in our Quality Control 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), but also the Empower Chromatography software and additional software controlling analytical equipment.

The role requires a detailed understanding of the LIMS and Empower systems used by QC and its maintenance requirements.

The IT system administrator will own the system validation packages, the SOPs, and associated training packages.

The position requires compliance with regulatory requirements to cGMP.

Unique to this position is the chance to define the way we work with laboratory IT systems at Genmab.

You will be joining a small team of ambitious and professional colleagues within related fields, who can help you settle into your role, and keep the spirit high while performing the important tasks for our laboratory.

The laboratory is newly established, so expect a pioneering atmosphere, where you will help adjust the ways of working in an efficiency oriented direction.

We expect you to be ambitious, motivated, self-driven, and to be able to make your colleagues shine in an environment of respectful and flexible collaboration.

You will report to Team Lead, QC systems.

Responsibilities 

  • Liaison between System Users, Application Managers (IT) & QA.

  • Drives Business related aspects of system application operations, design, testing, and improvements.

  • Manage user access administration and providing initial and on-going training for users.

  • Responsible for practical aspects of maintaining the validated state of GxP systems.

     
  • Ensure data integrity and compliance with company SOPs, requirement specifications, and cGMP regulations.

  • Load and configure method templates in LIMS and Empower.

  • Perform all aspects of QMS processes – Change Control, Deviations, CAPAs – for software used in QC lab.

  • Report achievements and escalate issues.

Requirements 

  • It is expected that you have at least 5 years of documented professional experience working according to GMP in a QC setting  
  • You have a thorough understanding of the detailed requirements for Software Validation and are up to date with current trends 
  • Experience with qualification of analytical instruments is desirable as you will be the owner of the validation and qualification activities
  • Experience in leading projects and driving cross-functional initiatives/stakeholders

About You

  • You are genuinely passionate about our purpose

  • You bring precision and excellence to all that you do

  • You believe in our rooted-in-science approach to problem-solving

  • You are a generous collaborator who can work in teams with a broad spectrum of backgrounds

  • You take pride in enabling the best work of others on the team

  • You can 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!

Locations

Genmab maximizes the efficiency of an agile working environment, when possible, for the betterment of employee work-life balance.

Our offices are crafted as open, community-based spaces that work to connect employees while being immersed in our powerful laboratories.

Whether you’re in one of our office spaces or working remotely, we thrive on connecting with each other to innovate.


Required Skill Profession

Computer Occupations



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