Senior Analyst, QC Compliance (Biopharmaceutical)

Location: Mississauga, Ontario, Canada. The role requires shift work, weekends, occasional extended shifts, and possible short-notice schedule changes.

Salary: $70,000–$107,500 per year.

Company

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

What you will do

• Lead and author OOS, laboratory, and deviation investigations, including CAPA closure.
• Manage change controls and CAPAs from initiation through implementation and closure.
• Review QC laboratory logbooks for completeness, data integrity, and Good Documentation Practices compliance.
• Compile QC data for Annual Product Quality Reviews and generate water system, LIR, and LE trend reports.
• Author, review, and approve SOPs, test methods, controlled documents, and compendial update assessments.
• Collaborate with Quality Assurance, Manufacturing, Validation, and other functions while serving as a QC Chemistry SME during regulatory inspections and client audits.

Requirements

• Experience leading OOS and deviation investigations, including CAPA closure, and authoring SOPs, test methods, and change controls.
• Advanced technical report writing, data analysis, and proficiency in chemistry analytical testing methodologies.
• In-depth knowledge of cGMPs, USP and EP standards, and regulatory expectations for biopharmaceutical testing.
• Ability to coach and mentor analyst-level staff and manage complex priorities independently.
• English proficiency is required for understanding, reading, writing, communication, and following instructions.
• Hepatitis A and B vaccination and pre-employment medical examinations, including eye and color-blindness testing, are required.

Nice to have

• Bachelor’s degree or higher in Chemistry, Biochemistry, or a related scientific discipline; an M.Sc. is preferred.
• 4–6 years of progressive QC Chemistry experience, including compliance, in a GMP-regulated biopharmaceutical or pharmaceutical environment.
• Knowledge of Health Canada, FDA, and EMA/EU Annex 1 requirements.
• Experience participating in Health Canada or FDA regulatory inspections as an active SME.

Culture & Benefits

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