Active Vacancy

Role Summary:
As a Quality Assurance Associate at CCRM you will be part of a diverse bioengineering team focused on designing and implementing quality management initiatives or programs within the cell and gene therapy, and regenerative medicine fields. You will provide technical expertise and will work within the team to define and execute project tasks. You will be a quality leader in bringing new and innovative products to market to enable life-saving advances in cell and gene therapy, and regenerative medicine.

Responsibilities:
• Technical expert with an in-depth understanding of the equipment and its purpose;
• Experience with creating easy-to-understand, simple, user friendly Standards of Practice (SOPs).
• Ability to review existing SOPs for content and focus on regulatory requirements;
• Produce other high-quality documents (i.e. validation protocols, specifications, manufacturing batch records ) that meet applicable standards and are appropriate for their intended audience;
• Train end-users on equipment use, maintenance and other quality procedures;
• Create log books/records
• Issue documents
• Liaise with clients and third party contract services to ensure quality support is provided when needed.
• Review and assess deviation, implementation of CAPAs, change controls, etc.
• Material release
• Assist with maintaining and continuously improving the quality systems
• Other process-related tasks that may arise.

Qualifications:
• Bachelor’s degree in science (bioengineering, chemical engineering, bioprocess, biotechnology, cell biology, microbiology, chemistry etc.)
• 2-3 years of experience in cell therapy/viral quality department supporting GMP production, or similar within the pharmaceutical, medical technologies, biologics, or similar industries.
• Training in quality assurance (certification with American Society of Quality etc.) preferred;
• Proven experience writing GMP documents (i.e. SOPs, validation procedures) is mandatory;
• Strong English written and oral communication.

Desired Characteristics:
• Understanding of Health Canada/US Food and Drug Administration GMP regulations and Quality Assurance principles;
• Ability to deliver high quality documents with specific attention to details;
• Ability to quickly grasp complex technical concepts and make them easily understandable in text and pictures;
• Excellent communication and interpersonal skills with assertive, responsible and accountable attitude;
• Strong working knowledge of Microsoft Office;
• Basic familiarity with a Quality Management System (QMS).