GMP QC Scientist: Analytical Testing & Compliance

Eli Lilly and Company; Toronto; On-site; CAD 69,000 - 101,000; Full time

Job summary

Lilly is seeking a QC Scientist to perform routine and advanced analytical testing, support method verification, and ensure full GMP compliance. The role involves investigations, documentation, instrument troubleshooting, cross-functional collaboration, and contributing to QC KPIs to drive quality and operational excellence.

The candidate will perform environmental monitoring, method qualification, and change control activities while maintaining lab operations and ensuring data integrity across

Qualifications

• BSc in Chemistry or related field from a recognized institution.
• Minimum of 5 years of experience in a regulated pharmaceutical or laboratory environment.
• Excellent written and verbal English communication skills.

Responsibilities

• 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.
• 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.
• 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.
• Understand the OOS investigation process including Phase I 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.
• Support calibration, troubleshooting, and routine maintenance of analytical instruments to ensure continuous operational readiness and data integrity.
• 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.

Skills

Analytical testing

Documentation

Quality systems

Laboratory troubleshooting

Data integrity

Education

BSc in Chemistry

5+ years regulated pharma/lab experience

Tools

Empower

Veeva

MS Teams

Outlook

Job description

Lilly is seeking a QC Scientist to perform routine and advanced analytical testing, support method verification, and ensure full GMP compliance. The role involves investigations, documentation, instrument troubleshooting, cross-functional collaboration, and contributing to QC KPIs to drive quality and operational excellence.

The candidate will perform environmental monitoring, method qualification, and change control activities while maintaining lab operations and ensuring data integrity across