Lead Specialist - Learning & Development - Fde

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 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.
Lilly employees embrace Operational Excellence in everything we do, to achieve our mission of Making Medicine with Safety First & Quality Always; following our common purpose under TEAM Lilly and our Manufacturing Standards under the strict code of conduct guided by our Red Book assuring data integrity in all we do in order to deliver a reliable supply of medicine for people around the world.
The Lead Specialist-FDE, Manufacturing and Quality Learning & Development (MQ L&D) Programs Support, is responsible for applying business support for the creation, revision, and implementation of learning content and documents to support learning initiatives related to Manufacturing and Quality (MQ) areas at the Branchburg, NJ site. The position is responsible to follow the document management suite of SOPs, support associated training, qualification, and communications for all Document Management System (DMS) roles (for example, Functional Document Controller Qualification). Support for L&D projects, identified as fulfilling the learning capability and addressing proficiency gaps in the MQ areas, in partnership with other L&D team members and/or supervisor will also be included. This role is also responsible to support training and learning projects and learning initiatives related to quality management, target audience identification, and instructor identification, as needed. The specialist supports communication and awareness regarding MQ training programs and initiatives and ensures the successful quality delivery of projects through the Lilly learning services supplier business process. This role will provide support to ensure personnel are qualified and capable, which includes the monitoring of personnel fulfilling compliance requirements. Responsibilities also include the administration of Job Descriptions and other documents, implementing the New Hire / Onboarding Process, coordinating the Read & Understand Effectiveness projects, manage and centralize the Branchburg Metrics & Communications in addition to other MQ/L&D projects as assigned.
Do you have experience in a regulated environment establishing strong relationships to get the job done? Come join the Lilly family and make an impact in patients' lives today!
Responsibilities:

• Centralized Document Controller Function for documents with training associated.
• Provide technical assistance throughout the document initiation, review, and approval process in the Document Management System.
• Prepare and route documentation packages throughout review and approval cycle.
• Track document approval activities in electronic tracking system; ensuring Document Management System and Learning Management System is updated and accurate; complete reports as needed.
• Ensure ongoing maintenance of personnel qualification requirements in manufacturing and quality areas (e.g., job descriptions, learning plan management and periodic review).
• Collaborate/participate in projects as identified by supervisor.
• Benchmark within Lilly MQ as appropriate, seeking sharing and replication opportunities.
• Perform LMS transactions and LRW (Learning Request Workflow), as needed.
• Support centrally developed process improvements in local business area/function.
• Responsible for maintaining a safe work environment, working safely and also accountable for supporting all HSE Corporate and Site Goals.

Basic Requirements:

• HS Diploma or equivalent (GED)
• 4 years of experience with business area document support such as Learning & Development business processes and related systems or supporting training activities.
• 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 this employment position.

Additional Preferences:

• Experience creating/revising training and GMP document control experience.
• Experience working in a GXP-regulated environment.
• Experience working in companion tools used to implement broader business processes (such as CAPA tools/Trackwise, document repositories (e.g., Veeva/QualityDocs), learning management system (e.g., SuccessFactors).
• Demonstrated organization and project coordination skills.
• Demonstrated ability to establish strong business relationships.
• Strong communication and sound judgment skills.
• Experience providing centralized support and coordination to a functional team.
• Experience in technical writing.

Additional Information:

• 8-hour days - Monday - Friday, on site work required, with additional overtime required as needed.
• This position is not permanent. It is for a fixed term position up to a maximum of 4 years.

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 ( Lilly_Recruiting_Compliance@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.
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