Senior Analyst, QC Compliance (QC Microbiology)

Location: Mississauga, Ontario, Canada; onsite role with shift work, weekends, occasional extended shifts, and possible short-notice schedule changes

Salary: CAD 70,000–107,500 per year

Company

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

What you will do

• Lead Out of Specification, laboratory, and deviation investigations for QC Microbiology.
• Manage change controls and CAPAs from initiation through implementation and closure.
• Review laboratory records, author and review SOPs and test methods, and maintain controlled documentation.
• Compile QC data for Annual Product Quality Reviews and generate trend reports for water systems, environmental monitoring, and laboratory investigations.
• Act as a QC Microbiology subject matter expert during Health Canada, FDA, EMA, and client inspections or audits.
• Coach analysts and technicians while aligning QC, QA, Manufacturing, and other partner functions on compliance decisions.

Requirements

• Advanced expertise in QC compliance and quality management systems, including OOS and deviation investigations, CAPA, change control, and document control.
• Experience authoring SOPs, test methods, and change controls, with strong technical report writing and data analysis skills.
• Proficiency in microbiology analytical testing and detailed knowledge of cGMPs, USP, EP, and biopharmaceutical testing requirements.
• Experience coaching Analyst-level staff and supporting regulatory inspections and internal audits.
• Must be able to understand, read, write, communicate, and follow instructions in English.
• Must be able to work shifts, weekends, extended shifts, cleanroom environments, and lift up to 20 kg.

Nice to have

• Bachelor’s degree or higher in Microbiology, Life Science, or a related discipline; an M.Sc. is preferred.
• Four or more years of progressive QC Microbiology experience in a GMP-regulated biopharmaceutical or pharmaceutical environment.
• Experience with Veeva Vault QMS, LIMS, SAP, Health Canada, FDA, EMA, or EU Annex 1 requirements.
• Experience presenting directly to regulators or clients as an inspection subject matter expert.

Culture & Benefits

• Annual cash bonus program.
• RRSP/DPSP with company matching and healthcare, dental, vision, life, LTD, and AD&D benefits.
• Fertility and family-forming benefits, paid vacation, paid holidays, and pregnancy and parental leave top-up.
• Tuition reimbursement and employee referral program.
• Accommodation support is available throughout the recruitment process.