QC Analyst

At Lilly, the work is demanding because patients are waiting. We unite caring with discovery to help make life better for people around the world, knowing that every decision, every detail, and every day matters. Headquartered in Indianapolis, Indiana, our over 50,000 employees around the globe take on complex challenges to discover and deliver life-changing medicines, strengthen how health is understood and managed, and support the communities we serve. This is hard, urgent, selfless work—but it’s work worth doing. If you’re driven by purpose and ready to bring your best to work that truly matters for patients, we invite you to join us.

We are looking for a QC Scientist to perform routine and advanced analytical testing, support method verification, and ensure full GMP compliance. The role includes conducting investigations, maintaining documentation, troubleshooting instruments, collaborating cross-functionally, and contributing to QC KPIs to drive quality and operational excellence.

Analytical Testing & Documentation   Perform analytical testing of raw materials, finished products, and stability samples using HPLC, GC, FTIR, and related validated methods.   Perform routine inspection of environmental monitoring (EM) samples including viable/non-viable particulate, surface sampling, sterility, and settle plates per cGMP and site SOPs.   Support method qualification, product qualification, and verification studies per cGMP and regulatory requirements.   Maintain accurate documentation, reports, and laboratory records per GMP standards.   Coordinate end-to-end materials management including subsampling, external lab shipments, results review, and specification completion for timely material release.   Maintain lab operations: monitor reagent/consumable inventory, initiate purchase orders, log incoming materials, and manage disposal per site and regulatory requirements.   Technical Documentation   Prepare method qualification and stability protocols/reports per USP, EP, and ICH guidelines.   Author, review, and support SOPs, specifications, test methods, change controls, protocols, and reports.   Change Control   Demonstrate thorough understanding of change control as it applies to QC lab activities including methods, instruments, reagents, and procedures.   Initiate change control requests with complete technical justification and all required supporting documentation prior to submission.   Actively track and follow up on assigned change controls to ensure timely closure within established site timelines.   Deviation, LI & OOS Investigation   Understand the OOS investigation process including Phase I (analyst error, instrument, sample prep) and Phase II, ensuring all steps are documented per FDA OOS Guidance and site procedures   Perform systematic, objective investigations using root cause analysis tools; document findings clearly per GMP.   Develop and implement risk-based CAPAs to prevent recurrence; ensure timely follow-up and verification of effectiveness.   Document all OOS and LI steps contemporaneously per ALCOA+ and data integrity principles.   Instrumentation   Support calibration, troubleshooting, and routine maintenance of analytical instruments to ensure continuous operational readiness and data integrity.   Microbiological Testing & Environmental Monitoring   Perform inspection and reading of environmental monitoring plates, sterility test bottles, and media fill samples per approved SOPs and cGMP requirements, reviewing results for accuracy and compliance prior to disposition.   Coordinate shipment of media samples to contract laboratories for Growth Promotion Testing (GPT), ensuring proper chain of custody and timely evaluation of results against acceptance criteria.   Support microbiology-related deviation investigations (e.g., unexpected growth, failed GPT) using structured root cause analysis.       E DUCATION &