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Added 2 mins ago
SM
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- Full-time
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Added 7 hours ago
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Scientist - Quality Control
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- Full-time
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Eli Lilly and Company

Scientist - Quality Control

Toronto, ON, Canada

$69,000 - $128,700 · Full-time

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Job details

Pay: $69,000 - $128,700
Job type: Full-time
Apply by: Dec 2, 2026
Experience: Minimum of 1 year experience in a regulated pharmaceutical or laboratory environment
Posting language: English
Posted: Nov 2, 2026

Original 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 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 escalate 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 clear 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 recurrence, and ensure timely follow-up and documented verification of CAPA effectiveness.

Project Management & Delivery

Lead and manage QC-related projects such as method validations, instrument qualifications, GSOP implementations, compendial updates, and stability program expansions, ensuring delivery on time and within scope.
Develop and maintain project plans, timelines, and status updates, communicating progress and risks proactively to QC management and cross-functional stakeholders.
Collaborate cross-functionally with Manufacturing, QA, Regulatory Affairs, and Development teams to ensure QC project deliverables align with site and business objectives.

KPI Monitoring & Continuous Improvement

Monitor, analyze, and report on QC KPIs including right-first-time testing rates, OOS/OOT frequency, investigation and CAPA cycle times, instrument availability, and compendial update completion.
Identify adverse KPI trends, perform gap analyses, and lead or support corrective actions to restore performance targets.
Champion continuous improvement initiatives within the QC laboratory, leveraging quality data and KPI outcomes to drive sustainable process enhancements.
Ensure the QC Laboratory is maintained in a ready state of compliance for internal and external audits.

Job Requirements / Education / Competencies

Bachelor of Science in Chemistry or a related field from a recognized educational institution
Minimum of 1 year experience in a regulated pharmaceutical or laboratory environment

Additional Skills

Master’s degree is an asset.
Knowledge of Radiopharmaceuticals is an asset.
Advanced laboratory computer skills including LIMS, chromatography data systems (e.g., Empower, Veeva), and related software.
Proficient in Microsoft Teams, Microsoft Outlook, and other Microsoft products.
Excellent written and verbal English communication skills, including the ability to present technical findings to cross-functional teams and management.
Strong leadership and interpersonal skills with the ability to mentor and develop junior staff.
Proven ability to manage multiple projects and competing priorities within established timelines.
In-depth working knowledge of change control, deviation, investigation, and CAPA processes from a QC laboratory perspective.
Must be willing to work flexible hours, including early mornings, late evenings, or weekends, as required by project or operational needs.

LILLY CORE EXPECTATIONS (R2–4)

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 - $128,700

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.

#WeAreLilly

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More about this job

Responsibilities

Lead and perform advanced QC testing, method verification and validation, and technical documentation while ensuring GMP compliance and data integrity. Manage investigations, change controls, GSOP implementation, laboratory projects, materials coordination, and KPI-driven continuous improvement.

Requirements

A bachelor's degree in Chemistry or a related field and at least one year of experience in a regulated pharmaceutical or laboratory environment are required. Candidates should have advanced laboratory software skills, strong English communication and leadership abilities, and working knowledge of QC change control, investigations, and CAPA; a master's degree and radiopharmaceutical knowledge are assets.

Skills

Analytical Testing
Gas Chromatography
Fourier-Transform Infrared Spectroscopy
Method Validation
Good Manufacturing Practice Compliance
Data Integrity
Laboratory Information Management Systems
Chromatography Data Systems
Change Control
Deviation and Investigation Management
Root Cause Analysis
Corrective and Preventive Actions
Project Management
Technical Documentation
Cross-Functional Collaboration

Benefits

Company Bonus
Pension Plan
Vacation Benefits
Healthcare Benefits
Flexible Benefits
Life Insurance
Death Benefits
Time Off and Leave Benefits
Well-Being Benefits
Employee Assistance Program
Fitness Benefits
Employee Clubs and Activities

Visa sponsorship

Not detected in the job text

Keywords

Quality Control
Good Manufacturing Practice
ALCOA+
Gas Chromatography
Fourier-Transform Infrared Spectroscopy
Method Validation
Method Verification
Stability Testing
United States Pharmacopeia
European Pharmacopoeia
International Council for Harmonisation
Laboratory Information Management System
Empower
Veeva
Data Integrity
Global Standard Operating Procedures
Change Control
Out-of-Specification
Out-of-Trend
Root Cause Analysis
Fishbone Analysis
5 Whys
Corrective and Preventive Actions
Instrument Qualification
Compendial Updates
Key Performance Indicators
Supply Chain Notifications
Radiopharmaceuticals
Stability Program

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