Associate - Material and Supplier Quality Assurance 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 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!
Position Description The Quality Assurance Associate for Materials Management is responsible for the site materials management systems. The Materials Management associate provides Quality Oversight for the suppliers and materials utilized by the site. This position supports all Materials Management activities relative to the Site in order to ensure appropriate Quality Oversight.
Key Objectives/Deliverables: Work with site staff and global resources to establish site material suppliers and service providers for startupCoordinates the appropriate tasks to develop and maintain the approved supplier and service provider listConduct material and supplier/material risk assessments and periodic reviews of supplier and service provider performanceCoordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirementsProvide input, guidance and recommendation for Supplier/Service Provider approval and certification activitiesMaintain supplier/service provider complaint and remarks database (track supplier responses for warehouse, incoming and service provider complaints)Review and assess with the appropriate cross-functional team Supplier Change NotificationsProvide input and guidance to site activities (e.g., six sigma, new product/process development, change controls) as material quality SMEBe able to perform materials SAP data steward functionsReview and Redline Materials and other GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.Provide the voice of quality to the Material Management Governance Committee and Supplier Certification Global Committee, providing input and support as needed in order to ensure complianceSupport regulatory inspection activities as needed by providing documentation and SME supportTrack and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance CommitteeLead, as required, local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulationsProvides support to the warehouse for incoming receipt, sampling and testingCreate and maintain documentation of the fully supply chain for materials, including supply chain maps Minimum Requirements: Experience working in the pharmaceutical or medical device industry in QA rolesPrevious materials management/supplier management experienceProficiency with material management computer systems and applications including Microsoft Office products, SAP, Veeva QDocs and TrackWise or similar systemsPrevious regulatory inspection readiness and inspection execution experienceStrong oral and written communication and interpersonal skillsAbility to influence externally with suppliers and resources across sitesResponsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site GoalsStrong technical aptitude and ability to work with component and technical stewardsAbility to work 8-hour days – Monday through FridayAbility to work overtime as requiredAbility to travel up to 10% for meetings and coordination with global regulatory organizations. Education Requirements: Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study or equivalent industry experience Additional Preferences: Previous equipment qualification and process validation experiencePrevious experience with device and parenteral product materialsCQA certification from the American Society for Quality (ASQ)Previous experience with deviation and change management systems including Trackwise and Veeva 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 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.
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