395373BR
Apr 10, 2024
Mexico

About the Role

This is an Open Role, Available for Immediate Job Selection

Relo statement: Novartis is unable to offer relocation support for this role. Please only apply if Mexico City is accessible for you. This role will remotely support international manufacturing locations.

About this role:

The Laboratory Information Management System (LIMS) Application Manager will administer, manage, and support automated digitalized laboratory business processes, information flow and documentation collection for laboratory testing lifecycles. The LIMS Application Manager will work closely with the equipment vendor and supporting Information Technology personnel on all system upgrades as well as support Quality Assurance and Quality Control operations and manufacturing activities involving LIMS and LIMS interfaces with other systems and equipment.

Key Responsibilities:

•English oral and written communicator who is proactive, responsive, and able to work independently with all levels of the organization. Ability to handle multiple conflicting tasks in a fast-paced environment is a must. Very high attention to detail is critical, including strong technical writing and proofreading skills.
•Perform general administration, support and maintenance of LIMS system, and stay current on advances in LIMS enhancements and maintain LIMS certifications. Translate customer goals and objectives into documented application configuration specifications and solutions. Actively participate in LIMS configuration and programming upgrades. Coordinate the development, testing and validation activities in response to requirements.
•Serve as a tier-1 and tier-2 resource for end-user questions and problems as well as perform system user training.
•Responsible for change request impact assessments involving LIMS which will include participation in meetings and work streams that affect LIMS such as site change control meetings, requirements gathering meetings, investigation or deviation meetings and continue to be involved in projects that impact LIMS.
•Initiate, monitor and oversee 3rd party contracts for LIMS programming and upgrades.
•Responsible for the development of reports generated from LIMS (i.e. Certificate of Analysis, Dose Report, Calculation Reports and Summary Reports). Ensure report content is accurate and aligns with source documents.
•Create and maintain training and account certification documentation; Stay current with site training objectives.
•Participate in the Global LIMS project to align site Development and Manufacturing with other TechOps sites throughout Novartis.
•Ensure that LIMS support staff follow QA/QC procedures for data analysis, data evaluation, data transfer and LIMS operation.

Diversity & Inclusion / EEO

We are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration and empowers our people to unleash their full potential.

Accessibility and Reasonable Accommodations: Individuals in need of a reasonable accommodation due to a medical condition or disability for any part of the application process, or to perform the essential functions of a position, please let us know the nature of your request, your contact information and the job requisition number in your message:

Job Sourcing Statement

You are applying to be part of the Novartis Talent Pool. We are not currently recruiting for this role but we are building a pipeline for future opportunities. If you would like to be considered for a similar position in future, then please submit your CV.

Role Requirements

Essential Requirements:

•Bachelor’s degree required in a Computer Science or Life Sciences related field; Master’s degree preferred.
•Minimum of 5 years of experience working as a LIMS super-user, Subject Matter Expert (SME), system analyst, or similar position.
•Fluent English speaking and written communication.
•Proficiency with general system administration including account creation, security role setup, reporting, instrument interfaces, data interfaces, workflows, etc.
•Experience in writing SOP’s, validation documents and reports for LIMS applications.
•The ability to work highly independently in pursuit of operational, tactical, and strategic goals.
•Experience with Crystal Reports and working knowledge of database technologies/Oracle and/or writing SQL Queries.
•Ability to plan, prioritize and execute multiple tasks simultaneously under tight deadlines and manage projects and lead teams utilizing modern project management methodology and tools.

Benefits and rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards

Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? https://www.novartis.com/about/strategy/people-and-culture

Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network

Operations
US PHARMA
Mexico
Ciudad de México
Technical Operations
Full Time
Regular
No
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395373BR

LIMS Application Manager, QC Support

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