Quality Assurance Specialist

About Moderna Biopharma Canada Corporation

Moderna Biopharma Canada Corporation is a forefront biotechnology firm focused on developing innovative mRNA-based therapeutics and vaccines. The company is dedicated to advancing healthcare globally by employing state-of-the-art technology and scientific expertise. Operating within a rigorously regulated environment, Moderna emphasizes quality, safety, and efficacy to meet stringent health authority standards. The company fosters a collaborative culture that encourages innovation, continuous learning, and improving patient health outcomes worldwide.

Role Overview

We are looking for a precise and committed Quality Assurance Specialist to join our team. This position plays a crucial role in ensuring the quality and integrity of our pharmaceutical products. The specialist will review manufacturing procedures, monitor quality systems, and investigate quality-related concerns to guarantee compliance with company policies, Good Manufacturing Practices (GMP), and regulatory requirements such as those by Health Canada. Collaboration with production, laboratory, and regulatory teams form an important part of efforts to drive continual improvement, uphold product safety, and support our mission to deliver safe and effective healthcare solutions.

Key Responsibilities

• Assess manufacturing documents, batch records, and validation reports for regulatory compliance.
• Monitor and audit quality systems and operational processes to detect enhancement opportunities.
• Conduct investigations and document cases of quality deviations, non-compliances, and customer complaints.
• Work collaboratively with production and laboratory personnel to resolve quality concerns and implement corrective and preventive measures.
• Participate proactively in internal and external audits to ensure compliance and readiness.
• Maintain meticulous records of quality assurance activities, investigations, and corrective measures.
• Contribute to the creation and revision of standard operating procedures (SOPs) and quality policies.
• Support training programs concerning quality assurance and compliance requirements.
• Keep abreast of the latest industry regulations and best practices to ensure continuous compliance.

Qualifications and Skills

• Bachelor's degree in Life Sciences, Pharmacy, Chemistry, Biology, or related disciplines.
• Previous background in quality assurance, pharmaceutical manufacturing, or biotechnology is advantageous.
• Comprehensive understanding of GMP regulations and quality assurance concepts.
• Strong communication and teamwork capabilities for effective cross-department collaboration.
• Competency in document review, quality investigations, and issue analysis.
• Detail-oriented with high accuracy and organizational aptitude.
• Ability to work autonomously and manage priorities efficiently.
• Proficient with Microsoft Office tools.
• Familiarity with Health Canada regulatory requirements is beneficial.

Benefits

Employees at Moderna Biopharma Canada Corporation enjoy competitive salary packages along with extensive health and dental benefits, retirement savings plans, and paid leave. The company encourages ongoing professional development to nurture career growth. It promotes an inclusive and cooperative culture that values diversity and innovation. Additionally, employees benefit from a modern work environment designed to support their well-being and promote a healthy work-life balance.

Equal Opportunity Employer

Moderna Biopharma Canada Corporation is committed to providing an equitable workplace where all individuals are treated with respect and fairness. The company does not tolerate discrimination on any basis including race, ethnicity, gender, age, sexual orientation, disability, or any other protected category. It values diversity as a key driver of innovation and success and encourages applicants from varied backgrounds to join the organization.