Global 1Lab & Empower System SME

Global 1Lab & Empower System SME (Subject Matter Expert)- Permanent Position.

Join an environment of excellence, where we’re backed by a belief that good can always be better. It means we search for opportunities to make valuable contributions – harnessing science and evidence to foresee risk. A place to continuously innovate to find new and better ways to ensure we are improving outcomes for patients.

Develop your expertise by being both challenged and supported to apply a ‘modern’ Quality approach. It means taking accountability and making brave decisions. Whether that’s reimagining the best way to respond to procedures and regulations, or pushing back when there’s disagreement. We partner and problem-solve with product and process guides to ensure we perform with excellence across the Quality network.

Job Responsibilities

• Build/maintain Lab Workflows ("Recipes") in the 1Lab system to follow lab testing data entry requirements
• To manage and maintain master data in the 1Lab system across the Development, Pre-Production and Production Environment
• Translating Lab methods/tests into step by step executable methods in the 1Lab system, including links to Equipment data capture and data fields which need to be populated to support lab testing.
• To provide support to Sites implementing the 1Lab system across the Globe and to support BAU maintenance. This would include regular site meetings to understand the needs of the customer, and also provide training/post go live hyper care.
• Supporting sites with Empower Queries and Supporting Empower business Changes.
• Depending on where the successful candidates would be based, a small amount of flexible working may be required to meet with sites in different time zones.
• To ensure 1Lab/Empower Global procedures are updated/created as appropriate
• Creating and reviewing user acceptance testing scripts for validation of data creation in the system
• Working with external contractors, and managing the workload & prioritization of tasks for them to complete.
• Support other Global 1Lab/Empower Activities such as supporting the Super User Forums and Governance Groups.
• To look for/support harmonization of ways of working across multiple sites
• Performing lessons learned and applying best practise principles across the network.

Essential Requirements:

• Experience of working within a QC Analytical, Microbiological and/or Biological Labs
• Being able to work collaboratively within own team and external groups.
• Flexibility to react to different customer needs/project demands
• Strong organisational skills and a high attention to detail
• Sound Knowledge and understanding of the principles of Good Laboratory/Manufacturing Practise (GxP)
• Able to work creatively to come up with solutions to unique problems within the compliance and lean framework
• As the application and most sites will be communicating requirements in English, Strong English reading/writing/speaking skills will be required
• Computer Literate
• Experience in using LES (1Lab, ELN, Smartlab/eLab or SciCord) or CDS (Such as Empower) systems.

Desirable:

• Experience in other QC applications (Such as GQCLIMS and MODA)
• Experience of managing Master data
• Execution of User Acceptance Testing or developing Testing Scripts

Why AstraZeneca?

At AstraZeneca, were dedicated to being an outstanding Place to Work. Where you are empowered to push the boundaries of science and spark your high-reaching spirit. There’s no better place to make a difference to medicine, patients, and society. We are an inclusive culture that champions diversity and partnership, and always committed to lifelong learning, growth, and development. We’re on an exciting journey to pioneer the future of healthcare!

So, what’s next?

Are you ready to bring new insights and fresh thinking to the table? Brilliant! We have one seat available, and we hope it’s yours.

Competitive salary and benefits.

📌Positions are open to Mexican Citizens and official residents of Mexico.
📍Location: Guadalajara (hybrid)
📌Strong English interpersonal skillss required.