Job DetailsAt 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.The Quality Assurance Associate for Materials Management is responsible for the site parenteral & device 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 for startup
- Coordinates the appropriate tasks to develop and maintain the approved supplier list
- Conduct material and supplier risk assessments and periodic reviews of supplier 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
- Provides support to the warehouse for incoming receipt, sampling and testing
- Maintain complaint database (track supplier responses for warehouse, incoming and operations complaints)
- 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
- Initiate supplier complaints (CARTs) when issues arise
- 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
Minimum Requirements:- Bachelor's degree in a science, engineering, computer, or pharmaceutical related field of study
- Experience working in the pharmaceutical or medical device industry in QA roles
Additional Preferences:- Previous facility or area start up experience
- Previous equipment qualification and process validation experience
- Previous experience with SAP or other inventory management systems
- 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
- Previous materials management and supplier management experience
- Proficiency with material management computer systems and applications including Microsoft Office products, SAP, Regulus, 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% to Indianapolis, IN for meetings and coordination with global regulatory organizations.
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