Quality Assurance and Compliance Specialist

Overview

Quality Assurance and Compliance Specialist Jobs in Cornwall, Ontario, Canada at Pureoyl Healthcare

Title: Quality Assurance and Compliance Specialist

Company: Pureoyl Healthcare

Location: Cornwall, Ontario, Canada

Position Summary

The Quality Assurance and Compliance Specialist at Pureoyl Healthcare is responsible for the development, implementation, and continuous improvement of our quality management systems (QMS) and validation protocols. This role ensures our operations remain in strict compliance with U.S. FDA and Health Canada GMP regulations, ISO 22716 (Cosmetics), and ISO 9001:2015. You will serve as a guardian of product integrity, bridging the gap between regulatory requirements and operational excellence through meticulous documentation and cross-functional leadership.

Key ResponsibilitiesQuality Management & Regulatory Compliance

• Develop and implement validation protocols aligned with international standards (U.S. FDA, Health Canada, ISO).
• Maintain a "culture of quality" by ensuring ongoing compliance with cGMP requirements and industry best practices.
• Stay current with evolving NNHPD (Natural and Non-prescription Health Products Directorate) and CFIA guidelines.

Documentation, SOPs & Recordkeeping

• Batch Record Management: Maintain, review, and approve batch production records to ensure 100% compliance with SOPs before product release.
• SOP Development: Create and update Standard Operating Procedures (SOPs) for validation, calibration, and general quality processes.
• Regulatory Submissions: Assist in the development of site license application packages and other critical regulatory filings.

Quality Control

• Testing of raw material: Should be ready to learn new laboratory instruments and testing procedures. Previous work experience on capsule machines and the pharmaceutical industry will be an asset.  
• Equipment Calibration: Ability to learn instruments, maintain records and calibrate timely. 
• Microbiological Testing: Vital for water-based products, this ensures the absence of harmful bacteria, yeast, and mold.
• Stability Testing: Products are subjected to varied temperatures and humidity to determine shelf life and ensure they don't separate or degrade over time.  
• Packaging and Labeling Compliance: Testing for leak-proof sealing and functionality and verifying that all legal requirements—including ingredient lists (INCI), usage instructions, and batch numbers—are correctly displayed and legible. 

Inspections & Deviation Management

• QC Inspections: Conduct rigorous inspections of incoming raw materials and packaging components against established specifications.
• In-Process Checks: Perform real-time quality checks during production to ensure finished goods meet regulatory and internal benchmarks.
• CAPA Management: Document and investigate non-conformances; lead root cause analysis and implement Corrective and Preventive Actions (CAPA).

Audits & Continuous Improvement

• Audit Leadership: Lead the preparation and execution of internal audits and external inspections (e.g., Health Canada/FDA).
• Process Optimization: Identify systemic gaps and propose data-driven improvements to enhance efficiency and product safety.

Qualifications

• Education: Bachelor’s degree in Chemistry, Microbiology, Pharmaceutical Sciences, or a related technical field.
• Experience: Minimum of 3 years in QA/QC within the healthcare, natural health products (NHP), or cosmetic manufacturing industry.
• Regulatory Knowledge: Deep understanding of U.S. FDA, Health Canada GMP, ISO 9001, and ISO 22716 standards.
• Technical Skills: Proficiency in document control software and Microsoft Office Suite.
• Attributes: High attention to detail, strong analytical problem-solving skills, and the ability to communicate complex regulatory requirements to production teams.