Analyst II, QC Microbiology

Location: Mississauga, Ontario, Canada; onsite work in controlled and classified areas

Salary: CAD 28.50–39.50 per hour

Company

hirify.global is a technology-focused biomanufacturing company developing sustainable, end-to-end manufacturing solutions for medicines.

What you will do

• Perform microbiology testing, including LAL/endotoxin, bioburden, sterility, microbial identification, biological indicator, and growth promotion testing.
• Conduct environmental monitoring of classified and non-classified areas, including air, particle, surface, compressed air, water, and gown monitoring.
• Prepare samples, reagents, standards, controls, documentation, and method suitability protocols and reports.
• Analyze, interpret, and report microbiology and environmental monitoring data, including adverse trend escalation and organism risk assessments.
• Lead assigned OOS, laboratory, environmental monitoring, and deviation investigations; develop change controls and CAPAs.
• Author SOPs and test methods, support media fill training, and mentor QC microbiology analysts.

Requirements

• Solid knowledge of microbiology testing methods, aseptic technique, cleanroom behavior, cGMPs, and compendial requirements.
• At least 2 years of relevant experience in a GMP-regulated biopharmaceutical or pharmaceutical laboratory environment is preferred.
• Bachelor’s degree in Microbiology, Life Sciences, or a related discipline, or a microbiology diploma/certification with equivalent experience.
• Proficiency with MS Word and Excel, data analysis, report preparation, accurate recordkeeping, and mathematical calculations.
• English proficiency is required for understanding, reading, writing, communication, and following instructions.
• Ability to work in cleanrooms, complete gown qualification, stand for extended periods, lift up to 10 lb, and work at heights over three meters when required.

Nice to have

• Experience with Veeva, Novatek, SAP, or similar computerized applications.
• Prior aseptic operations experience.
• Knowledge of Health Canada, FDA, EMA/EU Annex 1, USP, and EP requirements.

Culture & Benefits

• 18-month fixed-term contract with a schedule that may range from 12:00 PM to 9:00 PM, including evenings and weekends when required.
• Annual cash bonus program and RRSP/DPSP with company matching.
• Healthcare, dental, vision, life, LTD, AD&D, fertility, and family-forming benefits.
• Paid vacation, paid holidays, parental leave top-up, tuition reimbursement, and employee referral program.
• Hepatitis A and B vaccination and periodic medical examinations, including eye and color-blindness testing, are required.