QC Key User

Sanofi•Swiftwater, PA

1d•Onsite

About The Position

The Key User is essential to Quality Operations at the Swiftwater, PA site, serving as a primary resource for the maintenance, improvement, and governance of LIMS database applications and associated equipment supporting the sampling and testing. This role supports Business and Digital LIMS Administrators in creating and updating master data for new and existing products, EM sampling and analyses, maintaining system documentation, and providing ad hoc support to other departments. In addition, the Key User is responsible for the administration and support of the LIMS database applications, ensuring the integrity of environmental monitoring data and alignment of EM programs, procedures, templates, and alarms. The Key User is expected to play a critical role in bridging business requirements and technical solutions, ensuring both the LIMS and EM systems remain aligned with operational, quality, and regulatory standards. The candidate may be required to interact with health authorities during inspections and must be adaptable and able to react quickly to changing priorities in a high-stress environment. Join a global network that powers how Sanofi delivers — seamlessly, purposefully, and at scale. In Manufacturing & Supply, you’ll help reimagine how life-changing treatments reach people everywhere, faster. About Sanofi: We’re an R&D-driven, AI-powered biopharma company committed to improving people’s lives and delivering compelling growth. Our deep understanding of the immune system – and innovative pipeline – enables us to invent medicines and vaccines that treat and protect millions of people around the world. Together, we chase the miracles of science to improve people’s lives.

Requirements

Bachelor's degree in Computer Science, Life Sciences or related fields.
Excellent written and verbal communication skills with the ability to lead and participate in cross-functional teams.

Nice To Haves

Experience in the use and administration of a LabWare LIMS, including LIMS Basic.
Prior experience with EM databases, including OneLiMs and MODA.
Prior experience with quality applications such as Qualipso.
Strong working knowledge of laboratory processes, including cGMPs in a pharmaceutical environment.
Experience in system testing, validation, and master data management.
Familiarity with 21 CFR Part 11 data integrity best practices in a pharmaceutical environment.
Prior experience with Microsoft Office, specifically Excel and PowerPoint.
Experience with complementary laboratory and enterprise systems (e.g., laboratory instrument control and acquisition systems, Empower, Crystal Reports, NuGenesis, SAP).
Experience with SQL and database structures.
Experience in the development and delivery of end-user training.
Ability to assess processes and workflows to identify and implement opportunities for improvement.
Flexibility to cover evenings and weekends as necessary to support business and operations needs

Responsibilities

Ensure site on-time implementation of LIMS activities through support of master data configuration and data migration, system validation, SOP revisions, and development of end-user training.
Conduct system and process training, as well as system audits covering user access and data accuracy.
Serve as Administrator for EM database applications, assigning EM site locations, creating and managing templates and alert/action levels, and managing particle counters to ensure EM Program, area-specific procedures, EM templates, sites, and alarms are in alignment.
Configure and maintain instrument interfaces to laboratory equipment.
Manage global system updates and changes, which may include new modules and workflow changes.
Develop and manage LIMS improvement projects.
Provide technical support of LIMS to Quality Control, Batch Release, Production, Stability, and R&D operations.
Provide first-level diagnostic of incidents and support business users, Global Digital LIMS Administrator, and Support Center in the management and timely resolution of technical issues.
Support the business and Global Digital LIMS Administrator in the creation, validation, and maintenance of reports, calculations, and queries.
Responsible for the master data management process, including the updating of specifications and supporting the approval process.
Support the business and Global Digital LIMS Administrator in the definition, approval, and validation of new business requirements.
Support and maintain the integrity of EM database applications by identifying and correcting errors, communicating errors to Manufacturing & Supply (M&S), and driving corrections as part of the Data Management Systems request process.
Ensure that the LIMS complies with all relevant regulatory standards.
Play a key role in system governance through participation in local, regional, and global governance committees.
Provide ad hoc support to other departments to ensure compliance with all regulatory standards.
Support audits and inspections by providing data and information on request, including potential direct interaction with health authorities during inspections.
Create and maintain processes to improve the regulatory review process.