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.
Organization Overview:
Indianapolis Device Manufacturing (IDM) is responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly's portfolio. This includes the development and delivery of test systems and test methods in support of design verification, production, and complaint handling.
Responsibilities:
The Principal Associate - Contract Manufacturing (R1-R3) or Sr. Principal Associate - Contract Manufacturing (R4) provides oversight and support to contract manufacturing operations of medical devices and combination products. The primary responsibility is to oversee the quality of the components, sub-assemblies, and finished devices manufactured at the Contract Manufacturers (CM) and supplied to Internal Lilly sites. The Quality Assurance Associate provides assistance and guidance on deviation investigations, CAPA, change control, batch release, equipment qualification, process validation, audits, complaints, design verification, and design validation.
Ensure that components, sub-assemblies, and finished devices has been manufactured and released in compliance with cGMPs
Evaluate if products manufactured at the CM meet requirements for batch release
Review/approve GMP documents for CMs process manufacturing including: protocols, technical reports, deviations, change controls, inspection procedures and specifications, sampling plans, sort/rework procedures, and validation packages
Ensure that Root Cause Investigations (RCIs) are complete, corrective or preventive actions are taken, and effectiveness checks are appropriate to address quality related issues at IDM and CMs
Provide data (inputs) for management review, monthly metrics, quarterly business reviews, site compliance reporting, and post-launch risk management reporting
Participate in Failure Modes and Effects Analysis (FMEA)
Initiate and support continuous improvement projects
Assist with internal audits and supplier audits and maintain supplier management requirements
Support molding and non-molded part validation at CMs
Support design verification activities
Manage CM Quality Agreements and Quality Plans; ensure the expectations are monitored and met at the CM
Participate on joint process teams
Maintain knowledge and application of CM QMS to enable quicker, risk-based decisions relative to product quality
Coordinate process and design changes with assembly sites
Verify effectiveness activities
Additionally for R3-R4 candidates:
Perform GMP reviews for internal procedures
Conduct GQS gap assessments and establish action plans with controlling mechanism for closure
Consult/work with Regulatory to assure compliance with applicable registrations and requirements
Coach and mentor cross-functional peers
Basic Requirements:
Bachelor’s Degree - Preferred in STEM discipline
1 year industry related experience
Qualified applicants must be authorized to work in the United States on a full-time basis. Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
Additional Skills/Preferences:
Experience working with contract manufacturers and suppliers
Knowledge of global medical devices and combination product regulations (e.g. 21CFR820, 21CFR Part 4, Part 11, ISO 13485, ISO 11608, Canadian MDR, EU Medical Devices Directive/Regulation, JPAL, TGA, ANVISA)
Knowledge of Quality System elements and their application in a manufacturing environment
Experience with plastic molding/assembly operations
Experience with Outlook, Microsoft applications, Trackwise, Veeva, SAP, Darwin, and Master Control
Effective communication, interpersonal, and networking skill
Self-management skills
Strong attention to detail
Ability to work as part of a team
Problem solving skills
Meets commitments and deadlines
Ability to multi-task and manage competing priorities
Strong technical writing skills and proficiency in technical review of documents
Strong organizational, time management and planning skills
Additional Information:
Ability to work in a dynamic and fast paced environment
Overtime may be required to meet business requirements
Some US and OUS travel will be required (approximately 10-25%)
On call by cell phone during non-business hours
This position is located at LTC-North in IDM
The job responsibilities of this position support the technical ladder process
Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.
Lilly is proud to be an EEO Employer and does not discriminate on the basis of age, race, color, religion, gender identity, sex, gender expression, sexual orientation, genetic information, ancestry, 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 are open to all employees. Our current groups include: Africa, Middle East, Central Asia Network, Black Employees at Lilly, Chinese Culture Network, Japanese International Leadership Network (JILN), Lilly India Network, Organization of Latinx at Lilly (OLA), PRIDE (LGBTQ+ Allies), Veterans Leadership Network (VLN), Women’s Initiative for Leading at Lilly (WILL), enAble (for people with disabilities). Learn more about all of our groups.
Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is
$65,250 - $169,400Full-time equivalent employees also will be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a company-sponsored 401(k); pension; vacation benefits; eligibility for medical, dental, vision and prescription drug benefits; flexible benefits (e.g., healthcare and/or dependent day care flexible spending accounts); life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities).Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.
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