Senior Quality Assurance Associate

STEMCELL Technologies•Burnaby, BC

5d•CA$58,500 - CA$79,100•Onsite

About The Position

STEMCELL Technologies is seeking a Senior Quality Assurance Associate for our team! 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.

Requirements

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

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