QA Analyst jobs in Rouge, ON

The QA Associate supports the Quality Management System (QMS) by ensuring compliance with applicable quality standards, regulatory requirements, company procedures, and accreditation requirements, including ISO 9001 and ISO/IEC 17025.

This role requires strong attention to detail and experience working within regulated environments, preferably in calibration, validation, laboratory, pharmaceutical, or similar industries. Duties, Responsibilities and Authorities Quality Management System (QMS) Support

• Support the maintenance and continuous improvement of the QMS in accordance with company procedures, GMP requirements, ISO 9001, and ISO/IEC 17025 standards. Support the control, monitoring, and maintenance of quality-related equipment, reference standards, and associated records. Document Review & Control
• Prepare, review, revise and approve quality-related documentation including calibration certificates, validation protocols, validation reports, SOPs, quality records, and other controlled documents.
• Maintain document control processes and ensure records are accurate, complete, and compliant with applicable requirements. Audit & Accreditation Support
• Support internal audits and assist with external audits, customer audits, accreditation assessments, and regulatory inspections. Investigations & CAPA
• Participate in investigations related to deviations, nonconformances, customer complaints, and other quality events.
• Support root cause analysis, CAPA activities, and the implementation of corrective actions. Training & Quality Records
• Provide and document quality-related training and maintain training and quality records in accordance with company procedures and regulatory requirements. Continuous Improvement
• Assist in the collection and analysis of quality data and participate in continuous improvement initiatives. Compliance Support
• Collaborate with operational teams to ensure adherence to quality requirements and applicable standards.
• Support the approval, and ongoing monitoring of external service providers, suppliers, and subcontractors.
• Identify and escalate quality or compliance concerns to management.
• Perform other quality-related duties as assigned.

Qualifications, Knowledge and Skills Requirements

• Exceptional attention to detail and accuracy.
• Sound judgment and commitment to quality, compliance, and continuous improvement.
• Strong organizational and time management skills.
• Good understanding of the theory of metrology and traceable calibration.
• Competent in interpreting technical data (e.g. product specifications, schematics). Experience creating & implementing procedures and documentation.
• Knowledge of Quality Systems; Nonconformity and CAPA Process and Document Control.
• Strong oral and written communication skills.
• Comfortable working in a deadline-driven and fast-passed environment. Educational / Experience Requirements
• College Diploma or Bachelor's Degree in science or engineering
• 1~3 years of experience in metrology, calibration, validation, laboratory, a manufacturing, or pharmaceutical environment
• Quality, GMP, ISO 9001, ISO/IEC 17025, Internal Auditor, Validation, or Calibration-related training/certifications are considered an asset. Training Requirements (Post-Hiring)
• Quality Management System (QMS) training GMP / GDP training
• Internal Auditor Training, as required.
• Job-specific and procedural training as required.
• Lab activities specific training as required.

Rémunération : 60 000,00$ à 65 000,00$ par an

Lieu du poste : En présentiel