QC Key User

Job Title: QC Key User

• Location: Swiftwater, PA

About the Job

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.

Main Responsibilities:

LIMS Administration & Maintenance

• 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.

LIMS Technical Support & Incident Management

• 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.

LIMS Master Data & Business Requirements

• 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.

Governance, Compliance & Audit Support

• 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.

About You

Mandatory 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.

Preferred Requirements

• 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

Why choose us?

•  Bring the miracles of science to life alongside a supportive, future-focused team. 

• Discover endless opportunities to grow your talent and drive your career, whether it’s through a promotion or lateral move, at home or internationally. 

• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact. 

• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks’ gender-neutral parental leave.

• Shape the future of medicine and vaccine delivery with cutting-edge technology, ensuring seamless launches and a resilient global supply.

• Power industry-leading performance by leveraging digital, data, and AI-driven innovation – at speed and scale

• Transform lives worldwide by delivering life-changing treatments anywhere, anytime.

Sanofi Inc. and its U.S. affiliates are Equal Opportunity and Affirmative Action employers committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status; domestic violence victim status; atypical cellular or blood trait; genetic information (including the refusal to submit to genetic testing) or any other characteristic protected by law.

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All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.