Role Overview:
This role provides support to the Indianapolis Device Assembly and Packaging (IDAP) materials management systems. The Materials Management representative provides Quality Oversight for the suppliers and materials utilized by the IDAP Site. This position supports all Materials Management activities related to IDAP Products to ensure appropriate Quality Oversight
Key Responsibilities:
- Coordinates the appropriate tasks to maintain the Approved Supplier List including additions, deletions and modifications to existing materials and suppliers.
- Conduct material and supplier risk assessments and periodic reviews of supplierperformance.
- Coordinate and write Supplier, Service Provider, and Affiliate Quality Agreements, including networking with site resources to ensure compliance to associatedrequirements.
- Provide input, guidance and recommendation for Supplier / Service Provider approval and certification activities.
- 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, ifnecessary.
- Review and Redline GMP documents, including specifications and procedures. Provide procedure ownership and subject matter expertise, as necessary.
- Provide the voice of quality to the IDAP Supplier Committee, providing input and support as needed in order to ensure compliance.
- Support regulatory inspection activities as needed by providing documentation and SMEsupport.
- Track and report materials management metrics to Supplier Relationship Meetings, supplier committees, and Materials Management Governance Committee.
- Work with global resources, as necessary, to achieve compliance withrequirements.
- 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 Experience:
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Demonstrated relevant experience in a GMPfacility.
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Proficiency with current computer systems and applications including Microsoft Office products, SAP, EDMS and TrackWise or similar systems.
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Strong oral and written communication and interpersonalskills.
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Ability to influence externally with suppliers and resources acrosssites.
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Responsible for maintaining a safe work environment, working safely and accountable for supporting all HSE Corporate and Site Goals.
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Experience with Lilly deviation and change controlprocesses.
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Experience in material management, quality systems andcGMPs
Education & Experience:
- Bachelor’s degree or equivalent experience in a science-relatedfield with 5 to 10 years of experience in a relative function.
Lilly 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.