Lilly Quality Control Lab Systems Analyst in Branchburg, New Jersey
At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our 35,000 employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.
At Lilly, we serve an extraordinary purpose. We make a difference for people around the globe by discovering, developing and delivering medicines that help them live longer, healthier, more active lives. Not only do we deliver breakthrough medications, but you also can count on us to develop creative solutions to support communities through philanthropy and volunteerism.
This position will provide in depth support to the QC laboratories for new and existing computerized laboratory systems and databases. Assist in the selection, implementation, maintenance, and continuous improvement of computerized systems within the QC laboratories. Serve as a technical lead on system implementation and validation projects and serve as a technical representative on project teams. Provides technical support in the diagnosis and resolution of QC computerized system issues. Identify compliance and data integrity issues related to QC computerized systems and implement effective resolutions.
Act as business representative and contact SME for laboratory systems e.g., StarLIMS, MODA, NuGenisis, Empower, LabX
Serve as a primary interface with customers including but not limited to QC, IDS, VTS, QA and vendors related to QC computerized systems.
Provide support, troubleshooting, and maintenance of QC lab systems (providing ‘on-call’ service, as needed).
Assist with the selection and implementation of computerized systems within the QC laboratories, as well as upgrades to existing systems.
Provides training, documentation and post- implementations support to users to the new application and or systems.
Lead site deployment and upgrade activities of QC laboratory systems.
Serve as a technical lead on QC computer system validation projects, driving the technical implementation and design/configuration of these systems required to achieve group and corporate objectives (also reviewing validation documentation and executing IQ/OQ/PQ protocols as needed).
Author and manage change control related to QC computer systems, as needed.
Ensure validated computerized lab systems are maintained in a manner compliant with corporate and regulatory requirements (including 21 CFR Part 11).
Identify compliance issues and process improvements related to the ongoing administration of QC computerized systems, implementing effective resolutions.
Bachelor’s Degree in a scientific field related to the lab (e.g., Chemistry, Microbiology or Biology) with a minimum of 1-3 year of equipment life cycle management experience
Proficient and familiar with the operation of laboratory equipment such as HPLCs, spectrophotometers, plate readers, etc.
Working knowledge and understanding of computer system validation requirements and data integrity in laboratory systems
Strong knowledge and hands on experience on data and systems lifecycle methodologies, ISPE GAMP 5 system development lifecycle methodologies, and regulatory requirements: 21 CFR Parts 11, 210, and 211.
Experienced in handling quality deviations, impact assessments, root cause analyses, and development of CAPAs in a dynamic, multi-functional, and regulated environment.
Previous experience in a cGMP regulated environment related to QC laboratories or computer systems.
Understanding of laboratory quality system and their dependencies such as StarLIMS, Empower, MODA, NuGensis, etc.
Understanding of laboratory equipment qualification.
Previous experience with creating Capital Investment Requests.
Demonstrate strong oral, written communication and interpersonal interaction skills.
Critical analytical thinker with strong troubleshooting skills.
Shift information: M-F Days
Position location: Branchburg, NJ
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As a condition of employment with Eli Lilly and Company and its subsidiaries in the United States and Puerto Rico, you must be fully COVID-19 vaccinated and provide proof of vaccination satisfactory to the company (subject to applicable law).
At Lilly we strive to ensure our employees are part of a team that cares about them and our shared purpose of making life better for those around the world. How do we do this? We continue to look for ways to include, innovate, accelerate and deliver while maintaining integrity, excellence and respect for people. We hope that you seek to join us on our journey as we create medicine and deliver improved outcomes for patients across the globe!