We are seeking a Senior Associate, Quality Assurance to strengthen and oversee the quality assurance development at Aspect Biosystems. 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).
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.
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.
Qualifications & Experience
Education & Experience: You hold a Bachelor's degree or Master’s degree in Biology, Biotechnology or another relevant discipline and 2-3+ 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.
Detail-Oriented: You have outstanding attention to detail as well as process rigour. You take pride in your work and strive for excellence.
Intellectually Curious: You have a burning desire to learn more and aren’t afraid to ask questions.
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 $79,000 - $89,000, 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 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!
