Eli Lilly

Sr. Scientist - QC

Eli Lilly • $69K — $146K *
Scarborough, ON M1B 0A1In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor of Science in Chemistry or related field; Master's degree is a plus.
  • 5+ years in regulated pharmaceutical or lab environment; 2+ years in senior QC role.
  • Advanced laboratory computer skills including LIMS and chromatography data systems.
  • Proficient in Microsoft Teams and Outlook, with excellent communication skills.
  • Leadership skills with the ability to mentor junior staff and manage competing priorities.

Responsibilities

  • Perform and oversee advanced analytical testing using methods like HPLC and GC.
  • Lead method verification studies according to regulatory requirements.
  • Serve as a data integrity champion, maintaining compliance with ALCOA+ principles.
  • Author and review technical documents as a subject matter expert (SME).
  • Lead implementation of Global SOPs in alignment with local procedures.
  • Manage change controls and deviations, ensuring timely closure and documentation.
  • Oversee QC project management, collaborating with cross-functional teams for successful delivery.

Benefits

  • Opportunities for technical leadership and mentorship of junior staff.
  • Involvement in continuous improvement initiatives within the QC laboratory.
  • Hands-on role with advanced analytical testing and method validation responsibilities.
  • Collaboration with cross-functional teams enhances visibility and career growth.
  • Flexibility in working hours to accommodate project needs.
Full Job Description
Sr. Scientist - QC

Quality-Quality Assurance-R2

JOB SUMMARY

We are looking for an experienced and technically Senior Quality Control (QC) scientist to lead and perform advanced analytical testing, support method validation and transfers, and ensure full compliance with GMP standards. In addition to hands-on analytical responsibilities, the Senior QC scientist will provide technical leadership and mentorship to junior QC staff, drive investigations and quality events to closure, oversee change control activities, and contribute to the continuous improvement of QC laboratory operations.

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; Master's degree is an asset.
  • Minimum of 5 years of experience in a regulated pharmaceutical or laboratory environment, with at least 2 years in a senior or lead QC role.


ADDITIONAL SKILLS

  • 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.
  • Knowledge of Radiopharmaceuticals is an asset.
  • Must be willing to work flexible hours, including early mornings, late evenings, or weekends, as required by project or operational needs.

About Eli Lilly

ICOS Corporation is a biotechnology company that engages in the discovery, development, and commercialization of therapeutic products. It is engaged in the commercialization of treatments for unmet medical conditions, such as benign prostatic hyperplasia, hypertension, pulmonary arterial hypertension, cancer, and inflammatory diseases. It is the developer of a treatment known as Cialis (tadalafil), a product for the treatment of erectile dysfunction through its joint venture with Eli Lilly and Company in North America and Europe. It is also engaged in contract manufacturing services for third parties. It is in a strategic alliance with Solvay Pharmaceuticals, Inc. ICOS Corporation was established in 1989, based in Bothell, Washington. It is currently operated by Eli Lilly and Company.

Eli Lilly Careers

Joining Eli Lilly offers an unparalleled opportunity to become part of a leading global team dedicated to creating a healthier future. As a company revered for its commitment to innovation and leadership in the pharmaceutical industry, Eli Lilly is where your professional journey can flourish. Work You’ll Do At Eli Lilly, we are passionate about transforming patient care and advancing medical innovation. Our team at Eli Lilly is at the forefront of developing groundbreaking solutions in healthcare. By joining us, you will collaborate with some of the brightest minds in the industry, using cutting-edge technology to make real-world impacts. Lead with Innovation and Leadership Eli Lilly stands out in the marketplace by integrating deep industry expertise with robust research and development efforts. We are looking for professionals who are eager to drive change and lead the way in developing therapeutic breakthroughs. Explore Job Opportunities and Growth Eli Lilly offers a variety of career paths, including full-time positions and internships, across multiple functions such as research, marketing, IT, and sales. Whether you are a seasoned professional or a recent graduate, Eli Lilly provides an environment that promotes career growth and learning opportunities. Our commitment to diversity and leadership training ensures that every employee can achieve their potential. Be Part of Our Team Our team at Eli Lilly is committed to excellence and driven by a mission to improve lives. Employees enjoy a supportive culture that values collaboration, creativity, and diversity. We believe that a diverse workforce fosters innovation and helps us better connect with the communities we serve. Benefits and Culture Eli Lilly is dedicated to supporting our employees, offering competitive benefits, wellness programs, and comprehensive health care. Our culture is built on a foundation of respect, integrity, and quality, making Eli Lilly not just a great place to work, but a community to grow with. Networking and Professional Development Eli Lilly encourages continuous professional development and networking. With access to various training programs and mentorship opportunities, employees can enhance their skills and advance their careers. Our leadership is committed to nurturing talent through effective training and development strategies. Join Our Team Discover the exciting job opportunities at Eli Lilly by exploring open positions that match your skills and interests. We are continuously hiring and looking for individuals who are passionate, innovative, and ready to contribute to our mission of making life better for people around the globe. Stay Connected Keep up to date with the latest at Eli Lilly by following our careers blog. Gain insights from industry leaders and get tips on everything from crafting the perfect resume to preparing for your interview. Eli Lilly is not just a company—it's a place where you can make a difference. Explore the positions available and find out how your talents can help change the world. SEARCH ELI LILLY JOBS Stay ahead in your career with Eli Lilly, where innovation, leadership, and a commitment to diversity and growth lead the way to future advancements.
Learn more about Eli Lilly
Size
35,000 employees
Market Cap
$344.2 billion
Industry
Pharmaceuticals & Biotech
Net Income
$6.1 billion
Founded
1876
5 Year Trend
+5.9%
Revenue
$24.5 billion
NASDAQ
LLY
* Ladders Estimates

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