Qeen Biotechnologies is a global Center of Excellence for the biomanufacturing of nontraditional therapeutics. We provide services for the development and production of GMP and non-GMP bacteriophages and related delivery systems for the life sciences, pharmaceutical, agricultural, and veterinary industries.

Position

Summary The Quality Assurance Assistant supports the implementation and maintenance of the company’s Quality Management System (QMS) to ensure compliance with applicable regulatory and quality standards. This role assists with document control, training records, quality documentation, internal audits, and continuous improvement initiatives.

Working closely with the Quality team and other departments, the Quality Assurance Assistant helps ensure that quality processes are effectively implemented while supporting the needs of a growing biotech startup.

Key Responsibilities

· Maintain quality records, controlled documents, and document revision histories.

· Assist with document control processes, including issuance, review, approval, and archival.

· Support maintenance of the Quality Management System (QMS).

· Coordinate employee training records and quality training documentation.

· Assist in the management of deviations, nonconformances, CAPAs, and change controls.





· Support internal and external audits by preparing documentation and coordinating records.

· Assist with supplier qualification documentation and quality records.

· Monitor quality metrics and prepare routine quality reports.

· Participate in continuous improvement initiatives.

· Ensure compliance with Good Documentation Practices (GDP) and applicable regulatory requirements.

· Provide administrative support to Quality Assurance activities and special projects.

QualificationsRequired

· Diploma or Bachelor’s degree in Life Sciences, Biotechnology, Quality Assurance, or a related field.

· 1–3 years of experience in a quality, laboratory, manufacturing, or regulated setting.

· Strong organizational skills and attention to detail.

· Proficiency in Microsoft Office.

· Excellent written and verbal communication skills.

Preferred

· Experience with ISO 13485, ISO 9001, GMP, GLP, or other regulated quality systems.

· Experience with electronic Quality Management Systems (eQMS).

· Experience in a biotechnology or medical device environment.

Key Competencies

· Attention to detail

· Organization and documentation

· Quality mindset

· Analytical thinking

· Collaboration

· Time management

· Adaptability in a fast-paced startup environment

📌 Quality Assurance Assistant (Gatineau)
🏢 Qeen Biotechnologies
📍 Gatineau