Dublin College Park, Ireland
20 hours ago
QC 1Lab System Specialist APICOM - FTC

QC 1Lab System Specialist FTC (End date 31st Dec 2026)

Location: Dublin, Ireland

Closing date: 4th February 2025

Competitive Salary and Bonus

Introduction to role

At AstraZeneca, we are committed to pushing the boundaries of science to deliver life-changing medicines. The APICOM facility plays a vital role in our global strategy, serving as a centre of excellence for the development and launch of small molecule Active Pharmaceutical Ingredients (API) that make a real difference for patients worldwide. The 1Lab System Specialist is a 2-year fixed-term contract role and will play a key role in supporting the rollout and implementation of the 1Lab system at the APICOM QC laboratory, working closely with the global team to align with AstraZeneca’s overarching Quality Control (QC) systems strategy. This role focuses on configuring, maintaining, and supporting the 1Lab system locally while actively contributing to global initiatives and ensuring harmonization across QC testing sites.

The 1Lab system is an electronic platform designed to capture lab data, including raw data such as reagents used, volumes, and instrument measurements. It consists of three main parts:

Hub: Supports solution preparation and sample analysis.CisPro: Tracks lab reagents and generates barcode labels.Metrology: Maintains an interactive logbook for instrument usage, calibration, and verification.

This system interfaces with other QC systems such as GQCLIMS, Empower, and SAP. It is being rolled out globally across all of our sites.

Accountabilities

In this FTC role up until 31st December 2026), you will focus on the implementation and support of the 1Lab system at the APICOM QC laboratory while aligning with global processes and strategies. Key responsibilities include:

Local Implementation and Support

Configure and maintain lab workflows ("Recipes") in the 1Lab system to meet the specific needs of the APICOM QC laboratory and project timeframes.Translate local lab methods/tests into step-by-step executable methods in the 1Lab system, including links to equipment data capture and required data fields.Serve as the main point of contact for 1Lab system-related queries and issues at the APICOM QC laboratory.Deliver training and ongoing support to local users during and after system release.Collaborate with local QC teams to ensure compliance with Good Laboratory/Manufacturing Practice (GxP) during system implementation.

Collaboration with Global Teams

Work closely with the global 1Lab team to ensure local implementation aligns with global standards and strategies.Participate in global super-user forums and governance groups, providing feedback and sharing lessons learned from the local rollout.Support global harmonization efforts by discovering opportunities to standardize workflows across sites.Contribute to the development and review of global procedures and user acceptance testing (UAT) scripts.

System Maintenance and Continuous Improvement

Manage and maintain master data in the 1Lab system for the APICOM facility across Development, Pre-Production, and Production environments.Collaborate with external contractors to prioritize and manage local tasks and system updates.Monitor system performance to find opportunities for improvement in order to improve lab efficiency and compliance.

Essential Skills/Experience

Experience working within a QC Analytical, Microbiological, and/or Biological lab environment.Strong organizational skills and high attention to detail.Sound knowledge of Good Laboratory/Manufacturing Practice (GxP) principles.Proven ability to work collaboratively within your team and with external groups.Flexibility to adapt to evolving customer needs and project demands.Strong problem-solving skills, with the ability to develop creative solutions within a compliance and lean framework.Strong English reading, writing, and speaking skills, as most communications will be in English.Proficiency in using computer systems and software.Master Data coding experienceExperience of managing LIMS Master Data

Desirable Skills/Experience

Previous experience using Lab Execution Systems (LES) such as 1Lab, ELN, SmartLab/eLab, or SciCord.Experience with other QC applications such as GQCLIMS, Empower, and MODA.Experience in managing master data and system configuration.Experience in executing User Acceptance Testing (UAT) or developing testing scripts.

At AstraZeneca, our work is important and valued. We have an unrivalled forward-looking mindset, always innovating and trialling the latest models and technologies to improve reliability and excellence in our processes. Here you'll feel empowered to step up, follow the science, and make decisions that put patients first. Our team is ambitious, proactive, science-based, and solutions-oriented. We work together across functions, sites, and regions to ensure we deliver what will have the biggest impact on our patients.

Are you ready? Join us at AstraZeneca and be part of a team that is making a real difference in patients' lives!

We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status. We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation!

Date Posted

21-Jan-2025

Closing Date

03-Feb-2025

Our mission is to build an inclusive and equitable environment. We want people to feel they belong at AstraZeneca and Alexion, starting with our recruitment process. We welcome and consider applications from all qualified candidates, regardless of characteristics. We offer reasonable adjustments/accommodations to help all candidates to perform at their best. If you have a need for any adjustments/accommodations, please complete the section in the application form.
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