Associate - QA Master Data Steward

Responsibilities

• Develop and provide oversight to the Specification program
• Manage master data in SAP and LIMS at startup and routine manufacturing
• Support data management for change controls and deviations
• Prepare for and participate in internal and external regulatory inspections
• Acts as a liaison for US and OUS customers toward resolution of concerns from customers

Requirements

• BS in Engineering or science related field
• 3+ years in pharmaceutical industry

Qualifications

• Qualified applicants must be authorized to work in the United States on a full-time basis.
• Lilly will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.

Skills & Preferences

• Previous experience in pharmaceutical industry
• Previous experience in QA, TS/MS QC or Engineering
• Previous experience with cGMPs or external regulations
• Previous experience with root cause investigations