Location: Concord,CA, USA
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.
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.
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 startup
* Coordinates the appropriate tasks to develop and maintain the approved supplier and service provider list
* Conduct material and supplier/material risk assessments and periodic reviews of supplier and service provider performance
* Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associated requirements
* Provide input, guidance and recommendation for Supplier/Service Provider approval and certification activities
* Maintain 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 Notifications
* Provide input and guidance to site activities (e.g., six sigma, new product/process development, change controls) as material quality SME
* Be able to perform materials SAP data steward functions
* Review 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 compliance
* Support regulatory inspection activities as needed by providing documentation and SME support
* Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee
* Lead, as required, local or global teams, committees, or other groups to resolve quality issues and ensure site compliance to Lilly Standards and external regulations
* Provides support to the warehouse for incoming receipt, sampling and testing
* Create 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 roles
* Previous materials management/supplier management experience
* Proficiency with material management computer systems and applications including Microsoft Office products, SAP, Veeva QDocs and TrackWise or similar systems
* Previous regulatory inspection readiness and inspection execution experience
* Strong oral and written communication and interpersonal skills
* Ability to influence externally with suppliers and resources across sites
* Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals
* Strong technical aptitude and ability to work with component and technical stewards
* Ability to work 8-hour days - Monday through Friday
* Ability to work overtime as required
* Ability 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 experience
* Previous experience with device and parenteral product materials
* CQA 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 ( 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.
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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