Job Information
Lilly Concord IDS Analyst (CSV) in Concord, North Carolina
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.
Job Description:
Lilly is entering an exciting period of growth and we are committed to delivering innovative medicines to patients around the world. Lilly is investing over $1 billion to create a new state-of-the-art manufacturing site, in Concord, North Carolina. The brand-new facility will utilize the latest technology to increase the company's manufacturing capacity in parenteral (injectable) medications, device assembly and packaging operations. This is an exciting once-in-a-lifetime opportunity to help build and operate a new site. The Lilly Concord site will be built using the latest high-tech equipment, advanced highly integrated and automated manufacturing systems, and have a focus on minimizing the impact to our environment. This is an opportunity you don’t want to miss!
Organization Overview:
Manufacturing and Quality Information and Digital Services (MQ IDS) supports manufacturing operational excellence and productivity efforts through utilization of information and technology. MQ IDS strives to enable the making of medicine “with safety first and quality always”
Responsibility:
The IDS Analyst (CSV & Data Integrity) will partner with the Site Data Leader and Site IDS leadership to implement the DI culture and strategy for site IDS. This role will leverage a deep understanding of DI principles and computer system validation (CSV) methods ensuring compliance with regulatory requirements, consistent application, and sustainability for local and global IDS systems used at the Concord site.
This role will collaborate with the site organizations and global MQ IDS teams to enable best practices, processes, and governance and to consider new points to strengthen the IDS DI position and align with corporate objectives and initiatives.
Key Objectives/Deliverables:
The role will have business, technical, and application knowledge relied upon by leadership to:
This role will be responsible for the implementation of the DI culture and strategy for site IDS ensuring compliance with global and local regulatory requirements for systems used at the site (both local and global).
Coordinate the technical evaluation with site IDS subject matter experts (SMEs) of new and existing systems from a DI and CSV perspective.
Provide CSV consulting and assist with articulation of CSV needs to the CSV third party service provider(s).
Lead the implementation of technology solutions across the site to improve DI /CSV compliance.
Collaborate internally and externally to establish best practices and evaluate new points of consideration to improve technology use at the site.
Partner with the Site Data Leader and site IDS leadership to lead the gap analysis and remediation efforts of policies associated with DI/CSV related to Good Documentation Practices (GDP) and CSV.
Represent site MQ IDS in DI/CSV related deviations and CAPAs.
Provide support in the event of internal, external, and regulatory audits.
Partner cross-functionally with site DI SMEs to ensure a common, systematic approach to meeting existing and new DI/CSV expectations. This includes, but is not limited to, audit trail management, workstation security, and connecting stand-alone equipment.
Solves problems while exhibiting judgment.
Ensures Lilly information assets are protected from malicious content and access to information is restricted to authorized personnel only
Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
Basic Requirements:
Experience working in a regulated industry (i.e., GMP) and strong understanding of quality processes in IT applying to manufacturing and distribution.
Proficiency with CSV and demonstrated ability to right-size validation based upon risk.
Ensure compliance and inspection readiness for DI/CS across the IDS computer systems used at the Concord site.
Bachelor’s Degree in Business Administration with Major in Information Systems, Computer Science or Programming; or BS in IT, Chemistry, Pharmacy, Science, Engineering or equivalent.
Ability to communicate effectively in written and verbal form (in English), with proven success at delivering key messages to both management and peers across multiple business functions.
Additional Preferences:
Working knowledge of IT applications and/or hardware utilized within Parenteral operations.
Knowledgeable of Parenteral Products manufacturing and packaging.
Working knowledge of IT Life Cycle management, IT Business Process Model, S95 model, LSEF, and other IT processes
Other Information:
8-hour days, possible after-hour support
Occasional travel may be required.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability, or any other legally protected status.
Qualified candidates must be legally authorized to be employed in the United States. Lilly does not anticipate providing sponsorship for employment visa status (e.g., H-1B or TN status) for employment positions on the B or S paths or at levels M1-M2 or P1-P4.
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Eli Lilly and Company, Lilly USA, LLC and our wholly owned subsidiaries (collectively “Lilly”) are committed to help individuals with disabilities to participate in the workforce and ensure equal opportunity to compete for jobs. If you require an accommodation to submit a resume for positions at Lilly, please email Lilly Human Resources ( LillyRecruitingCompliance@lists.lilly.com ) for further assistance. Please note This email address is intended for use only to request an accommodation as part of the application process. Any other correspondence will not receive a response.
Lilly is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
Our employee resource groups (ERGs) offer strong support networks for their members and help our company develop talented individuals for future leadership roles. Our current groups include: Africa, Middle East, Central Asia Network, African American Network, Chinese Culture Network, Early Career Professionals, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinos at Lilly, PRIDE (LGBTQ + Allies), Veterans Leadership Network, Women’s Network, Working and Living with Disabilities. Learn more about all of our groups.
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).
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