Senior Analyst, QC Compliance (Biopharmaceutical)

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

Base pay: CAD 70,000–107,500 per year

Company

Technology-focused biomanufacturing organization developing sustainable, end-to-end manufacturing solutions for medicines and scientific discovery.

What you will do

• Lead and author OOS, laboratory, and deviation investigations, including CAPA closure.
• Lead 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 APQRs and generate trend reports for water systems, LIR, and LE.
• Author, review, and approve SOPs, test methods, controlled documents, and compendial updates.
• Collaborate with Quality Assurance, Manufacturing, Validation, and other functions while supporting inspections and mentoring QC staff.

Requirements

• 4–6 years of progressive QC Chemistry experience, including compliance, in a GMP-regulated biopharmaceutical or pharmaceutical environment.
• Bachelor’s degree or higher in Chemistry, Biochemistry, or a related scientific discipline; an M.Sc. is preferred.
• Experience leading OOS and deviation investigations, closing CAPAs, and authoring SOPs, test methods, and change controls.
• In-depth knowledge of cGMPs, analytical chemistry methodologies, USP and EP standards, data analysis, and technical report writing.
• Knowledge of Health Canada, FDA, EMA, and EU Annex 1 requirements; regulatory inspection SME experience is an asset.
• Ability to understand, read, write, and communicate effectively in English; vaccination for Hepatitis A and B and recurring medical examinations are required.

Culture & Benefits

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