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Aspect Biosystems

Quality Assurance Specialist

Vancouver, BC, Canada

The hiring range for this role is $73,863 - $92,329, annually.

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Job details

Pay: The hiring range for this role is $73,863 - $92,329, annually.
Posting language: English
Posted: Oct 1, 2026

Original job description

We are seeking a Quality Assurance Specialist to strengthen and oversee our quality assurance development. You will pioneer and execute quality assurance activities associated with clinical Good Manufacturing Practices (GMP) of our bioprinted cell therapies. With a passion for optimization, you will also drive continuous improvement of our manufacturing and quality systems by developing, applying, revising, and maintaining quality metrics.

Responsibilities

Support in development of internal QA processes and procedures and implementation of the company’s Quality Management System (QMS).
Maintain and provide document control support.
Assist in development of training content for QA processes, maintain training and certification requirements for the position.
Identify and evaluate issues and/or gaps in processes and documentation and propose effective solutions to remediate.
Provide QA expertise on change management, and support implementation of documents, design, process, and material related changes.
Collaborate closely with R&D teams from the early development phases to embed quality standards directly into product designs, technical documentation, and underlying engineering processes
Support the internal vendor qualification program by ensuring vendor documents are up to date and compliant.
Be the quality assurance and documentation expert and support cross-functional groups on:

Reviewing study protocols and reports
Creating, reviewing, approving, and implementing SOPs, Policies, forms, and other controlled documents
Reviewing data for completeness
Completing root cause analysis/ investigations and implementing appropriate corrective and preventive actions.

Review executed batch records to ensure compliance with Good Documentation practices and procedures; communicate and resolve discrepancies with the cross-functional teams.
Collaborate routinely with the CMC and QC teams during processing, bioprinting and testing, ensuring buy-in and ownership of our quality program.
Assist in the development of critical raw material specifications and review and approve incoming raw materials.
Support in the development and implementation of critical CMC equipment qualification.
Assist in Risk Management by conducting risk assessments on core raw materials.
Other duties as assigned.

Qualifications & Experience

Education & Experience: You hold a Bachelor's degree or Master’s degree in Biology, Biotechnology or another relevant discipline and 5-7+ years of hands-on experience developing, or administrating GMP quality programs in biotech, medical device, or pharmaceutical environments.
Regulatory Expertise: Demonstrated knowledge and application of industrial regulations including those of FDA, EMEA, and other authorities related to Biologics and/or Pharmaceuticals. Experience with medical device regulations is a plus.
Detail-Oriented: You have outstanding attention to detail as well as process rigour. You take pride in your work and strive for excellence.
Go-Getter: You work with a sense of urgency, are results-driven, and thrive in a fast-paced, interdisciplinary, and entrepreneurial environment. You are willing to roll up your sleeves and do what it takes to get the job done.
Collaborative: You thrive in a multi-disciplinary team environment and believe that we can get further, faster by working together.

The hiring range for this role is $73,863 - $92,329, annually. Our ranges are based on market data. Offered salaries will be based on a combination of factors including, but not limited to, job-related knowledge, skills, education, and experience. For candidates who exceed role requirements, we are open to exploring above-range offers. Note that base salary is just one part of the overall compensation at Aspect. Members of the Aspect team also receive equity, a comprehensive benefits package, and support for continuous learning and career progression.

Who We Are

Aspect Biosystems is a biotechnology company pioneering the development of a novel category of regenerative medicine designed to restore or supplement biological function and deliver curative therapies for some of the most elusive diseases. Aspect is developing these bioengineered cellular medicines by applying its full-stack tissue therapeutic platform, which integrates proprietary AI-powered bioprinting technology, therapeutic cells, hypoimmune cell engineering, and advanced biomaterials. Aspect is advancing its therapeutic pipeline across multiple endocrine and metabolic diseases, including diabetes and rare endocrine disorders. If you are committed to making a real impact and accelerating the development of life-changing therapies, we want to hear from you!

Curious about our current perks and benefits? Learn more here.

At Aspect Biosystems, our strength has always been in our diversity. Different people, thinking differently, unified in creating a world that is better for us all. We are committed to creating an inclusive environment for everyone on our team.

All aspects of employment - including the decision to hire, promote, discipline, or terminate - are based on merit, competence, performance, and business needs. We do not discriminate on the basis of race, color, religion, citizenship status, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, political affiliation, or any other status protected under federal, state, provincial, or local law.

If you're interested in joining our team but don't see a job posting that matches your experience or background, we encourage you to submit a general application to be considered for future opportunities!

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More about this job

Responsibilities

The Quality Assurance Specialist will oversee and execute quality assurance activities for bioprinted cell therapies in compliance with GMP standards. They will also drive continuous improvement of manufacturing and quality systems by developing metrics, managing documentation, and collaborating with cross-functional teams.

Requirements

Candidates must hold a Bachelor's or Master's degree in Biology, Biotechnology, or a related field. They are required to have 5-7+ years of hands-on experience in GMP quality programs within biotech, medical device, or pharmaceutical environments.

Skills

Quality Assurance
GMP
Quality Management System
Document Control
Regulatory Compliance
FDA
EMEA
Biologics
Pharmaceuticals
Root Cause Analysis
Corrective and Preventive Actions
Risk Management
SOP Development
Batch Record Review
Vendor Qualification
CMC

Benefits

Equity
Continuous learning support
Career progression support

Visa sponsorship

Not detected in the job text

Keywords

Quality Assurance
GMP
Bioprinting
Cell Therapies
QMS
Document Control
FDA
EMEA
Biologics
Pharmaceuticals
Medical Device
SOP
Root Cause Analysis
CAPA
Batch Records
CMC
QC
Risk Management
Raw Materials
Biotechnology
Regenerative Medicine
AI-powered
Tissue Engineering
Compliance
Process Rigour
Change Management
Vendor Qualification
Technical Documentation
Engineering Processes
Quality Metrics

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