Sanofi
biopharma
QCKeyUser
Neural analysis suggests this role is
optimal for Mid+ candidates.
“QC Key User at Sanofi. Skills: LIMS Administration, LIMS Maintenance, master data management, technical support, governance, compliance. maintenance, improvement, and governance of LIMS database applications and associated equipment. creating and updating master data for new and existing products, sampling and analyses”
What You'll Achieve.
Ensure site on-time implementation of LIMS activities; Ensure that the LIMS complies with all relevant regulatory standards; improve the regulatory review process
Industry & Context.
identify and implement opportunities for improvement; diagnostic of incidents; error identification; error correction
Flexibility to cover evenings and weekends as necessary to support business and operations needs, interact with health authorities during inspections, adaptable and able to react quickly to changing priorities in a high-stress environment
What They're Looking For.
Must Have
Bachelor's degree in Computer Science, Life Sciences or related fields, Excellent written and verbal communication skills, ability to lead and participate in cross-functional teams
Nice to Have
Experience in the use and administration of a LabWare LIMS, including LIMS Basic, Prior experience with databases, including OneLiMs and MODa, Prior experience with quality applications such as Qualipso, 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
What You'll Do.
and governance of LIMS database applications and associated equipment
creating and updating master data for new and existing products
sampling and analyses
maintaining system documentation
providing ad hoc support to other departments
administration and support of the LIMS database applications
ensuring the integrity of environmental monitoring data
alignment of programs
bridging business requirements and technical solutions
ensuring LIMS and systems remain aligned with operational
and regulatory standards
site on-time implementation of LIMS activities
Conduct system and process training
Conduct system audits covering user access and data accuracy
Serve as Administrator for database applications
assigning site locations
creating and managing templates and alert/action levels
managing particle counters
Configure and maintain instrument interfaces to laboratory equipment
Manage global system updates and changes
Develop and manage LIMS improvement projects
Provide technical support of LIMS to Quality Control
Provide first-level diagnostic of incidents
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
and maintenance of reports
Responsible for the master data management process
Support the business and Global Digital LIMS Administrator in the definition
and validation of new business requirements
Support and maintain the integrity of database applications
Ensure that the LIMS complies with all relevant regulatory standards
Play a key role in system governance
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
Create and maintain processes to improve the regulatory review process
How You'll Work.
Team & Collaboration
lead and participate in cross-functional teams; support Business and Digital LIMS Administrators; support other departments; support business users, Global Digital LIMS Administrator, and Support Center; participation in local, regional, and global governance committees
Communication Scope
Excellent written and verbal communication skills
Process & Methodology
LIMS improvement projects development and management
Full Job Description
**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
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