Senior Associate, Quality Assurance

at  Aspect Biosystems

We are seeking a Senior Associate, Quality Assurance to strengthen and oversee the quality assurance development at Aspect Biosystems. Reporting to the Manager, Quality Assurance, this role will pioneer and execute quality assurance activities associated with clinical Good Manufacturing Practices (GMP) of Aspect’s bioprinted cell therapies. With a passion for optimization, this individual will also drive continuous improvement of Aspect’s manufacturing and quality systems by developing, applying, revising, and maintaining quality metrics.

QUALIFICATIONS

• Education: Bachelor’s in biology, biomedical engineering, experimental medicine, biotechnology, or related discipline.
• Professional Experience: You have 3 – 5 years of hands-on experience developing, or administrating GMP quality programs in biotech 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.

WHO WE ARE

Aspect Biosystems is a Canadian biotechnology company creating bioprinted tissue therapeutics to transform how we treat disease. Our bold team of innovators and entrepreneurs have joined us from all over the globe to create a new class of regenerative medicine and work towards a future where our bioprinted tissues are used to save lives and make people healthier. We are endlessly curious and wildly passionate about what we do. Every person on our team is a key contributor to our success and is eager to roll up their sleeves to make a difference in the ever-changing world of biotech. 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, colour, religion, marital status, age, national origin, ancestry, physical or mental disability, medical condition, pregnancy, genetic information, gender, sexual orientation, gender identity or expression, veteran status, or any other status protected under federal, 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

• 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 document, design, process, and material related changes.
• 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 carrying out risk assessments on core raw materials.