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Quality Assurance Specialist
2 months ago
We are seeking a highly skilled Quality Assurance Specialist to join our team at 4 Pillars Search Group Inc. as a contract employee for a twelve-month period, working 40 hours per week on-site.
Key Responsibilities- Participate in FDA and Health Canada inspections, ISO certification, and audit processes to ensure compliance with regulatory standards.
- Facilitate the development of a Quality Management System (QMS) to meet regulatory requirements.
- Maintain updated documents, ensure records are accurate, and adhere to Good Documentation Practices (GDP).
- Verify, manage, and revise documents for distribution to departments.
- Ensure operations are executed according to Standard Operating Procedures (SOPs).
- Generate non-conformance reports for deviations found during quality inspections.
- Identify non-conformities and planned deviation processes to oversee the execution of Corrective Action and Preventive Action (CAPA) commitments.
- Perform inspections and release incoming raw and packaging materials.
- Assist in validation activities for products and processes, identifying sampling and testing plans.
- Identify continuous improvement opportunities.
- Relevant post-secondary degree.
- At least 2 years of experience within a Quality Management System.
- QA experience in manufacturing, pharmaceutical, or medical devices is preferred.