Sr. Associate Materials Management QA
Eli Lilly and Company
5 hours ago
On-site
Lebanon, IN
$65,250 - $169,400 USD yearly
Operations
Responsibilities:
- Support business partners and MMQA colleagues to enable timely release of raw materials, excipients, GMP consumables, packaging components, and supplier qualification activities.
- Assist with qualification activities for suppliers of purchased materials by collecting documentation, preparing assessments, and coordinating reviews for GMP use.
- Collaborate with site staff and global resources to support risk assessments and make recommendations for Supplier/Service Provider approval.
- Participate in periodic supplier performance reviews by preparing data summaries and supporting documentation.
- Draft, route, and maintain Supplier, Service Provider, and Affiliate Quality Agreements.
- Provide quality support to materials management operations, including supplier certification-related activities as requested.
- Support incoming material receipt, sampling, and testing workflows to ensure compliance.
- Execute batch disposition of incoming materials and consumables per quality requirements.
- Perform SAP data steward functions (data entry, verification, updates).
- Review and redline GMP documents (e.g., specifications and procedures) with oversight as needed.
- Maintain materials management metrics data and provide updates to stakeholders.
- Assist during internal/external regulatory inspections by retrieving documentation and supporting preparation.
- Support evaluation of GMP-related incidents (initial assessments; contribute to RCA and CAPA investigations).
- Escalate issues to management as appropriate and assist with follow-up actions.
- Contribute to audit readiness and inspection-related activities as assigned.
Basic Requirements:
- Bachelor’s degree in science, engineering, computer, or related field and 1–3 years’ experience supporting Quality Assurance in pharmaceutical manufacturing or biotech.
- Strong oral and written communication skills; ability to work across cross-functional teams.
- Authorized to work in the United States full-time; Lilly will not sponsor work authorization/visas.
Additional Skills/Preferences:
- Experience working with suppliers/materials in a regulated pharmaceutical environment.
- Experience with SAP or other inventory/materials management systems.
- Working knowledge of global pharmaceutical manufacturing and supplier oversight regulations (US/EU/Japan and others).
- Experience supporting facility/area start-up activities (preferred).
- Experience with deviation and change management systems.
- Demonstrated problem-solving and decision-making.
- Experience writing/updating GMP documents.
- Technical aptitude and ability to guide others in routine tasks.
Other Information / Application Instructions:
- N/A (accommodation request form available at https://careers.lilly.com/us/en/workplace-accommodation if needed).
- Support business partners and MMQA colleagues to enable timely release of raw materials, excipients, GMP consumables, packaging components, and supplier qualification activities.
- Assist with qualification activities for suppliers of purchased materials by collecting documentation, preparing assessments, and coordinating reviews for GMP use.
- Collaborate with site staff and global resources to support risk assessments and make recommendations for Supplier/Service Provider approval.
- Participate in periodic supplier performance reviews by preparing data summaries and supporting documentation.
- Draft, route, and maintain Supplier, Service Provider, and Affiliate Quality Agreements.
- Provide quality support to materials management operations, including supplier certification-related activities as requested.
- Support incoming material receipt, sampling, and testing workflows to ensure compliance.
- Execute batch disposition of incoming materials and consumables per quality requirements.
- Perform SAP data steward functions (data entry, verification, updates).
- Review and redline GMP documents (e.g., specifications and procedures) with oversight as needed.
- Maintain materials management metrics data and provide updates to stakeholders.
- Assist during internal/external regulatory inspections by retrieving documentation and supporting preparation.
- Support evaluation of GMP-related incidents (initial assessments; contribute to RCA and CAPA investigations).
- Escalate issues to management as appropriate and assist with follow-up actions.
- Contribute to audit readiness and inspection-related activities as assigned.
Basic Requirements:
- Bachelor’s degree in science, engineering, computer, or related field and 1–3 years’ experience supporting Quality Assurance in pharmaceutical manufacturing or biotech.
- Strong oral and written communication skills; ability to work across cross-functional teams.
- Authorized to work in the United States full-time; Lilly will not sponsor work authorization/visas.
Additional Skills/Preferences:
- Experience working with suppliers/materials in a regulated pharmaceutical environment.
- Experience with SAP or other inventory/materials management systems.
- Working knowledge of global pharmaceutical manufacturing and supplier oversight regulations (US/EU/Japan and others).
- Experience supporting facility/area start-up activities (preferred).
- Experience with deviation and change management systems.
- Demonstrated problem-solving and decision-making.
- Experience writing/updating GMP documents.
- Technical aptitude and ability to guide others in routine tasks.
Other Information / Application Instructions:
- N/A (accommodation request form available at https://careers.lilly.com/us/en/workplace-accommodation if needed).