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—and 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.

Job Summary

We are looking for a Quality Control (QC) scientist to lead and perform advanced analytical testing, support method validation and transfers, and ensure full compliance with GMP standards.

Job Responsibilities

Analytical Testing & Documentation

- Perform and oversee advanced analytical testing of raw materials, finished products, and stability samples using validated methods including HPLC, GC, FTIR, and related techniques.
- Lead method verification studies in accordance with cGMP, regulatory, and internal requirements.
- Prepare and review method qualification and stability protocols and reports in accordance with applicable compendial guidelines (e.g., USP, EP, and ICH).
- Maintain and ensure the accuracy of documentation, reports, and laboratory records in strict accordance with GMP and data integrity standards.
- Review raw materials, finished products, stability data, and technology transfer documents against approved protocols and procedures.
- 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.

Data Integrity

- Serve as a data integrity champion within the QC laboratory, ensuring all analytical data, laboratory records, and electronic systems are maintained in full compliance with ALCOA+ principles (Attributable, Legible, Contemporaneous, Original, Accurate, and Complete).
- Identify and elevate potential data integrity risks or gaps observed in QC laboratory practices, systems, or documentation, and support the implementation of corrective measures.

Technical Documentation & SME Support

- Author, review, and approve SOPs, specifications, test methods, change controls, protocols, and reports as a technical SME.
- Provide technical guidance to QC team members on method performance, instrument troubleshooting, and documentation best practices.

GSOP Implementation

- Lead and coordinate the site-level review, gap assessment, and implementation of Global SOPs (GSOPs) applicable to QC laboratory operations, ensuring local procedures are aligned with global standards and regulatory requirements.
- Collaborate with QA and cross-functional stakeholders to assess the impact of new or revised GSOPs on existing QC processes,



methods, and documentation, and develop an implementation plan with explicit timelines and ownership.
- Track and report on GSOP implementation progress at site, ensuring all required training, procedure updates, and system changes are completed within the established effective dates.

Supply Chain Notification Assessment

- Perform supply chain notification assessments in response to changes initiated by raw material suppliers, reagent vendors, or contract laboratories, evaluating the potential impact on QC test methods, specifications, analytical results, and product quality.

Change Control

- Demonstrate an in-depth understanding of the change control process as it applies to QC laboratory activities, including changes to analytical methods, instruments, reagents, and laboratory procedures.
- Initiate, author, and lead change control for QC-related changes, ensuring complete technical justification and all required supporting documentation prior to submission.
- Actively manage and track assigned change controls to ensure timely completion of all tasks and closure within established site timelines, escalating risks to QC management as needed.

Deviation & Investigation

- Demonstrate a thorough understanding of the deviation and investigation process, including initiation, execution, and closure from a QC laboratory perspective.
- Lead OOS/OOT and deviation investigations, applying structured root cause analysis methodologies (e.g., fishbone, 5-Why) to identify the true root cause and document findings clearly per GMP requirements.
- Develop risk-based, practical CAPAs as outcomes of investigations to prevent re

📌 Scientist - Quality Control (Toronto)
🏢 Eli Lilly
📍 Toronto