Senior Analyst, QC Compliance
$70,000–$107,500 year
On-siteMississauga, Ontario, Canada
Job Summary
Lead investigations for Out of Specification, laboratory, and deviation events; drive end-to-end Change Controls and CAPAs from initiation to closure. Review QC laboratory logbooks for completeness and data integrity compliance. Compile and evaluate data for Annual Product Quality Reviews and generate trend reports for water systems, LIR, and LE. Author, review, and approve SOPs, test methods, and controlled documents while managing compendial updates to ensure current regulatory alignment. Collaborate with cross-functional teams to maintain inspection readiness and serve as the QC Chemistry Subject Matter Expert during regulatory inspections and client audits. Mentor team members on quality systems and GMP documentation requirements. Report health and safety incidents and hazards.
Required Qualifications
- Demonstrated experience as Lead Investigator/Author on OOS and deviation investigations with CAPA closure
- Demonstrated authorship of SOPs, Test Methods, and Change Controls
- Advanced technical report writing and data analysis
- Proficiency in chemistry analytical test methodologies
- In-depth knowledge of cGMPs, compendial standards (USP, EP), and regulatory expectations for biopharmaceutical drug product and drug substance testing
- Demonstrated coaching and mentoring of Analyst-level staff
- Ability to work with a high degree of independence and manage multiple priorities and complex tasks
- Must have the ability to effectively understand, read, write, communicate, and follow instructions in the English language
- Pre-employment medical and medical re-examination, inclusive of eye examination and color blindness test, performed every 2 years or as per Resilience's SOPs
- This position requires vaccination for Hepatitis A and B
- Job requires shift work, weekends and occasional extended shifts and possible short notice schedule shift changes
- Bachelor's degree or higher in Chemistry, Biochemistry, or a related scientific discipline
- Typically 4–6 years of progressive QC Chemistry experience (including compliance) in a GMP-regulated biopharmaceutical or pharmaceutical environment
- Knowledge of US and international GMPs including Health Canada, FDA, and EMA/EU Annex 1 requirements and compendial standards (USP, EP)
Desired Qualifications
- M.Sc. is preferred
- Experience participating in regulatory inspections (e.g., Health Canada, FDA) in an active SME role is an asset
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