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
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