Biotech QA & GMP Compliance Specialist

Aspect-Biosystems; Vancouver; On-site; CAD 74,000 - 92,000; Full time

Benefits offered by this job

Equity

Benefits package

Continuous learning

Job summary

Aspect Biosystems in Vancouver, BC, is seeking a Quality Assurance Specialist to oversee GMP QA activities for bioprinted cell therapies. You will pioneer internal QA processes, maintain the QMS, and drive continuous improvement across manufacturing and quality systems.

You will collaborate with R&D, CMC, and QC teams from early development through manufacturing, review protocols and batch records, and support vendor qualification while ensuring compliance and documentation excellence.

Qualifications

• Bachelor's or Masters in Biology/Biotech with 5-7+ years GMP QA experience.
• Knowledge of FDA/EMEA regulations.
• Experience with QMS and document control.

Responsibilities

• Develop and implement internal QA processes and QMS.
• Maintain document control and training programs.
• Perform root cause analysis and CAPA activities.
• Review study protocols, SOPs, and batch records.
• Collaborate with R&D, CMC, QC during manufacturing and testing.

Skills

QA processes

Regulatory knowledge

Attention to detail

Collaborative

Process improvement

GMP experience

Education

Bachelor's or Master's in Biology/Biotech

Job description

Aspect Biosystems in Vancouver, BC, is seeking a Quality Assurance Specialist to oversee GMP QA activities for bioprinted cell therapies. You will pioneer internal QA processes, maintain the QMS, and drive continuous improvement across manufacturing and quality systems.

You will collaborate with R&D, CMC, and QC teams from early development through manufacturing, review protocols and batch records, and support vendor qualification while ensuring compliance and documentation excellence.