Job Description Summary

As the Senior Quality Assurance Associate, you will uphold quality standards and regulatory compliance by performing key quality activities, approving product outputs, maintaining quality documentation, and recommending continuous improvement initiatives. You will play a vital role in ensuring that all products meet specified quality requirements and regulatory standards, contributing significantly to the organization’s commitment to quality and compliance.

Please note that this role requires a flexible schedule that includes occasional early mornings, late evenings, and weekends depending on business needs.

Job Description

Duties and Responsibilities

• Provide comprehensive Quality oversight of GMP cleanrooms, manufacturing processes and products to ensure continuous compliance with regulatory standards

• Perform Line Clearance between batching campaigns and supporting activities, and providing real-time guidance to promptly resolve quality and compliance issues

• Execute and oversee key Quality Management System activities, including supporting change controls, maintaining robust documentation, and leading in the identification, investigation, and resolution of non-conformances

• Perform technical reviews of Standard Operating Procedures, work instructions,  and validation documents to guarantee accuracy, completeness and alignment with regulatory requirements

• Support site audit readiness by continuously monitoring manufacturing compliance while identifying and implementing process improvements to aid compliance and operational efficiency

Knowledge and Qualifications

• Bachelor’s Degree in relevant field with less than 2 years’ Quality Assurance and/or regulatory and process improvement experience in the biotech industry or equivalent 

• Knowledge of regulatory requirements and industry standards, including ISO 13485, CE medical and IVD device directives, and cGMP, with the ability to interpret and apply technical documents, procedures, and regulations

• Strong critical thinking, analytical, and problem-solving skills 

• Ability to coordinate and execute Quality Assurance responsibilities, manage multiple priorities in a fast-paced environment, and demonstrate strong project and time management skills

• Excellent communication, technical report writing, presentation, and interpersonal skills, with a self-motivated approach, independent work ethic, and willingness to learn and take on new responsibilities

#LI-KK1 #Bench #Onsite

This is an opportunity to work with highly motivated colleagues in a science-oriented, creative, and dynamic environment. We offer a competitive salary, excellent benefits, and meaningful career development opportunities.

STEMCELL is well recognized for exceptional leadership and business practices. We are one of Canada’s Best Managed Companies and operate an ISO 14001-certified environmental management system to measure and reduce our environmental impact. 

The annual salary for this job ranges from:

$71,200.00 - $96,400.00

STEMCELL determines an individual’s pay within the range based on multiple factors including experience, education, job-related skills, and equity within the team or organization. For jobs that are eligible for sales incentives, the range noted above is inclusive of target incentives; actual incentives are based on individual performance results in accordance with company policy. In addition to base salary, STEMCELL offers a comprehensive total rewards package including health benefits, retirement savings, and more.

To apply, please select the “Apply” button below. You will then be directed to a login screen asking you to set up an account, which is required to apply.​​