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About the role

  • QC Analyst performing GMP analytical and microbiological testing for Lilly’s life-changing medicines. Supporting investigations, method verification, documentation, and laboratory compliance in Toronto.

Responsibilities

  • Perform routine and advanced analytical testing of raw materials, finished products, and stability samples using HPLC, GC, FTIR, and validated methods
  • Inspect environmental monitoring samples, including viable/non-viable particulate, surface sampling, sterility, and settle plates
  • Support method qualification, product qualification, and verification studies under cGMP and regulatory requirements
  • Maintain accurate GMP documentation, reports, and laboratory records
  • Coordinate materials management, including subsampling, external lab shipments, results review, and specification completion for timely material release
  • Monitor laboratory reagent and consumable inventory, initiate purchase orders, log incoming materials, and manage disposal
  • Prepare method qualification and stability protocols and reports according to USP, EP, and ICH guidelines
  • Author, review, and support SOPs, specifications, test methods, change controls, protocols, and reports
  • Initiate, track, and close QC-related change controls
  • Perform deviation, laboratory incident, and OOS investigations using root cause analysis
  • Develop and implement risk-based CAPAs and verify effectiveness
  • Support calibration, troubleshooting, and routine maintenance of analytical instruments
  • Inspect and read environmental monitoring plates, sterility test bottles, and media fill samples
  • Coordinate media sample shipments to contract laboratories for Growth Promotion Testing
  • Support microbiology-related deviation investigations
  • Collaborate across peers, teams, and functions while contributing to quality and operational excellence

Requirements

  • BSc in Chemistry or related field from a recognized institution
  • Minimum of 5 years of experience in a regulated pharmaceutical or laboratory environment
  • Laboratory computer skills, including Empower and Veeva
  • Proficient in MS Teams and Outlook
  • Excellent written and verbal English communication 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
  • Willingness to work flexible hours, including early mornings, late evenings, or weekends as required

Benefits

  • Company bonus eligibility depending on company and individual performance
  • Pension plan eligibility
  • Vacation benefits
  • Healthcare benefits eligibility
  • Flexible benefits
  • Life insurance and death benefits
  • Time off and leave of absence benefits
  • Well-being benefits, including employee assistance program, fitness benefits, and employee clubs and activities
  • Disability accommodation support during the application process

Job title

Job type

Full Time

Experience level

Mid levelSenior

Salary

CA$69,000 - CA$101,200 per year

Degree requirement

Bachelor's Degree

Location requirements

OnsiteTorontoCanada

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