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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:

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.

Delivery Device and Connected Solutions (DDCS) and Indianapolis Device Manufacturing (IDM) are responsible for the development, commercialization, manufacture, and global technical stewardship of delivery devices used to administer many of the therapeutics in Lilly’s portfolio.

The QA Representative – Contract Manufacturing 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 Representative provides assistance and guidance on deviation investigations, CAPA, change control, batch release, equipment qualification, process validation, audits, complaints, design verification, and design validation.

Responsibilities:

• 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
• Perform IDM Batch Release process as requested by management
• 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

Basic Requirements:

• Minimum of 5 years industry related experience which may include Quality, Technical Services, LRL Product Development, and/or Manufacturing of medical devices
• Bachelor’s Degree in engineering or science related fields

Additional Skills/Preferences:

• Experience working with contract manufacturers and suppliers to partner and influence the quality mindset
• 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 matrixed 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:

• Some US and OUS travel may be required (approximately 10%)

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.

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.

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