Senior Quality Assurance Associate, Systems

Job Description Summary

STEMCELL Technologies is searching for a Senior Quality Assurance (QA) Associate to join our QA Systems team!

As a Senior QA Associate, you will contribute to upholding quality standards and regulatory compliance by performing key quality activities, maintaining quality documentation, and recommending continuous improvement initiatives. You will apply independent judgment to evaluate complex quality issues and implement effective solutions using current industry practices and methodologies. Through your expertise, you will help ensure that all products meet specified quality requirements and regulatory standards, contributing significantly to STEMCELL’s commitment to quality and compliance.

Job Description

Duties and Responsibilities

Perform key quality activities, focusing on nonconformance and corrective and preventive actions (CAPA) systems while supporting supplier corrective action requests (SCAR), change control, audit, and document management to maintain quality standards and ensure regulatory compliance

Conduct and facilitate investigations using industry standard methods for root cause determinations and identification of meaningful corrective and preventative actions

Conduct internal and external audits to assess compliance with applicable standards, regulations, directives, and organizational policies

Partner with cross-functional teams to ensure Quality Management System (QMS) compliance, analyze quality data (e.g., inspections, testing, audits, CAPA metrics, and quality key performance indicators), and recommend process improvements

Maintain accurate, complete, and compliant quality documentation, including policies, procedures, records, and quality system activities in accordance with regulatory requirements

Knowledge and Qualifications

Bachelor’s Degree in Life Sciences (e.g., Chemistry, Biology) or related field with 2-6 years of relevant QA experience

Knowledge of QMS, including nonconformance, CAPA, SCAR, change control, and document control

Solid understanding of regulatory requirements and industry standards, including ISO 9001, ISO 13485, CE medical/IVD device directives, and cGMP, with the ability to interpret and apply technical documents, procedures, and regulations

Demonstrated ability to coordinate QA responsibilities, maintain accurate quality and regulatory documentation, manage multiple priorities in a fast-paced environment, and apply strong organizational, project, and time management skills

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

#LI-KK1 #LI-Onsite

STEMCELL Technologies is a privately owned, Vancouver-based biotechnology company that helps power leading-edge life science research around the world. Driven by our love of science and passion for quality, we are a company of Scientists Helping Scientists—standing by our customers to provide the outstanding products, technical support, and training they need to advance their research. Scientists performing stem cell, immunology, cancer, regenerative medicine, and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, accessory products, and services.

Through our many regional offices, as well as our distribution centers in Vancouver, Seattle, Grenoble, and Singapore, we deliver our innovative, specialized products to more than 100 countries. With over 1,800 employees globally, most with scientific or engineering degrees, STEMCELL is proud to be the largest biotechnology employer in Canada.

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.

As an equal…