QC Analyst

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

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.

Job Summary

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.

Job Responsibilities

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.

EDUCATION & COMPETENCIES

• BSc in Chemistry or related field from a recognized institution.
• Minimum of 5 years of experience in a regulated pharmaceutical or laboratory environment

Additional Skills

• Laboratory computer skills (e.g., Empower, Veeva); proficient in MS Teams and Outlook.
• Excellent written and verbal English communication skills.
• Detail-oriented with strong problem-solving and organizational skills.
• In-depth knowledge of GMP, GLP, and data integrity (ALCOA+).
• Working knowledge of change control, deviation, LI, and OOS investigation processes.
• Operational and troubleshooting skills for analytical instruments.
• Proven time management skills as demonstrated through work and educational experience.
• Knowledge of Radiopharmaceuticals is an asset.
• Willing to work flexible hours including early mornings, late evenings, or weekends as required.

LILLY CORE EXPECTATIONS (R1–R4)

INCLUDE

• Influences & collaborates across peers, teams, and functions.
• Listens to learn & understand different views.
• Builds relationships across dimensions of difference.
• Speaks up with ideas, concerns & to ensure safety of others.
• Asks questions & invites others to contribute.

INNOVATE

• Anticipates & resolves key technical problems impacting function or project.
• Thinks creatively, tries new ideas & applies learnings.
• Anticipates, embraces & adapts to change.
• Invests in personal development & growth.
• Is curious & seeks input from others.

ACCELERATE

• Makes decisions based on available information impacting function or project.
• Is effective, efficient & decisive.
• Is goal & solution-focused.
• Is proactive, positive & determined.
• Seeks help & support from others when needed.

DELIVER

• Impacts own projects, peers, team and/or across teams/business areas.
• Performs high quality work.
• Demonstrates courage & integrity.
• Shares insights & collaborates with others.
• Follows through on commitments.

Lilly is dedicated to helping individuals with disabilities to actively engage in the workforce, ensuring equal opportunities when vying for positions. If you require accommodation to submit a resume for a position at Lilly, please complete the accommodation request form (https://careers.lilly.com/us/en/workplace-accommodation) for further assistance. Please note this is for individuals to request an accommodation as part of the application process and any other correspondence will not receive a response.

Lilly does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.

Actual compensation will depend on a candidate’s education, experience, skills, and geographic location. The anticipated wage for this position is $69,000 - $101,200 Full-time equivalent employees may also be eligible for a company bonus (depending, in part, on company and individual performance). In addition, Lilly offers a comprehensive benefit program to eligible employees, including eligibility to participate in a pension plan; vacation benefits; eligibility for healthcare benefits; flexible benefits (if applicable) life insurance and death benefits; certain time off and leave of absence benefits; and well-being benefits (e.g., employee assistance program, fitness benefits, and employee clubs and activities). Lilly reserves the right to amend, modify, or terminate its compensation and benefit programs in its sole discretion and Lilly’s compensation practices and guidelines will apply regarding the details of any promotion or transfer of Lilly employees.

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