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Organization Overview:
Indy Device Manufacturing (IDM) is an organization responsible for the manufacturing of medical devices and the delivery of the custom assembly equipment utilized as part of the manufacturing process. The Learning and Development team is part of the quality compliance and devices certification organization supporting IDM and provides support of programs and systems for administration of procedures and training.
Responsibilities:
The Learning and Development program associate is responsible for applying business technical expertise in the creation, revision, and implementation of SOPs and associated learning and performance support interventions across the assigned business area/function. This position is also responsible for quality management and instructor identification as needed. Further, this position, as assigned will be responsible for development and maintenance of an effective and robust Purchasing Controls and Supplier Management / Quality System ensuring consistent application of medical device regulations across Indy Device Manufacturing and Delivery Device and Connected Solutions organizations.
L&D/SOP Mangement
- Create, revise, and implement SOPs, training, and related documents, ensuring all documents are usable/executable, and compliant with Corporate and Local policies and procedures
- Ensure implementation and ongoing maintenance of personnel qualification requirements in assigned business area/function
- Facilitate the review/approval process (including meetings) required to review, reconcile, and resolve SOP and related document issues
- Identify, analyze, and recommend solutions regarding performance gaps
- Collaborate/participate and/or Lead projects
- Drive quality standards through review of project documents, compliance, design, deliverables, final learning content and evaluation of data
- Benchmark within Lilly Manufacturing & Quality as appropriate, seeking sharing and replication opportunities
Curriculum Architecture and Assignment
- Create and maintain duty aligned curricula in collaboration with business partners and support curricula owners in the assigned business area/function (including employee in/out process)
- Partner with Learning Data and Process personnel and/or ServiceNow for effective and timely implementation of learning and interventions, considering change impact on current population of (trained) learners and future/new learners
- Ensure accuracy and appropriateness of target audience definitions for courses owned by assigned business area/function in the Learning Management System(LMS)
- Troubleshoot curriculum architecture and assignment issues related to data and personnel as needed
Instructor Delivery (of internal instructors )
- Ensure internal instructor/facilitator qualification process is executed.
- Provided instruction and assist with employee onboarding as appropriate
- Partner with Learning Data and Process personnel and/or ServiceNow resources in the creation and maintenance of instructor information, course information, and scheduling information in the master scheduling system
Supplier Management Support (as assigned )
- Lead, mentor, and coach QA function in improving the IDM/DDCS Supplier Quality Management System, ensuring the development & sustaining of a robust purchasing controls system that guarantees consistent application of device regulations across the Pharmaceutical Delivery Systems (PDS) Network.
- Liason with Global QA - Procurement to ensure the IDM/DDCS Supplier Quality Management System maintains consistent implementation of the Lilly Global Quality Standards (GQS).
- Support alignment of IDM procedures with Lilly GQS and Common Quality Practices, in addition to, applicable governing standards and regulations.
- Support collection of data/information for site management review.
- Support continuous improvement projects related to supplier management and PDS Quality Management System.
- Ensure supplier quality related issues are assessed for the need of deviations or CAPAs for IDM and DDCS.
Basic Requirements:
- Bachelor's Degree or 5 or more years' experience with Technical Writing, Instructional Design, Visual Communication or related field.
- Experience in technical writing and creating/revising and technical review of training materials or other GMP documents
- Demonstrated project management skills
- Ability to establish strong business partnership across multiple functions and influence diverse groups
- Strong communication skills, ability to resolve conflicts effectively and management of complex tasks
- Strong administrative and organization skills.
Additional Skills/Preferences:
- Knowledge and experience with Regulatory Requirements (e.g., 21CFR Parts 210 and 211, 820, 803, and 806; ISO 13485; ISO 14971; Canadian MDR; EU Medical Device Directive/Regulation; JPAL; and other country specific MOH regulations).
- Knowledge of Lilly Quality Standards.
- Experience with Learning & Development business processes and related system
- Experience working in companion tools used to execute broader processes (such as CAPA tools/TrackWise, document repositories, LMS)
- Ability to coach and training new employees on work practices
- Ability to navigate complex, matrix-based organizations
- Human Performance Improvement (HPI) Certification
Additional Information:
Minimal travel may be required. Primary work hours are Monday-Friday
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