Quality Assurance Specialist
Location: Vancouver, BC
We are seeking a Quality Assurance Specialist to strengthen and oversee the quality assurance biologics development at Aspect Biosystems. Reporting to the Senior VP, Process Development and Manufacturing, you will pioneer and execute quality assurance activities associated with clinical cGMP of Aspect’s bioprinted cell therapies. With a passion for optimization, you will also drive continuous improvement of Aspect’s manufacturing and quality systems by developing, applying, revising, and maintaining quality metrics.
WHAT YOU'LL DO
- Review executed batch records to ensure compliance with approved procedures and communicate and resolve discrepancies with the manufacturing team.
- Collaborate daily with manufacturing operations during production, testing, and inventory functions, ensuring buy-in and ownership of our quality program.
- Provide hands-on guidance and expertise to the manufacturing team during GMP events and deviation investigations.
- Examine deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with current GMPs.
- Be the quality assurance expert and support cross functional groups on root cause analysis and corresponding corrective and preventive actions.
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Assist in the review and approval of incoming raw materials, and in the routine calibration of equipment.
- Complete internal and external audits, including documenting observations and overseeing the implementation of corresponding CAPAs.
- Perform quality review and evaluate standard operating procedures.
- Track metrics applicable to review processes, report the results, and provide suggestions to management and other stakeholders.
- Maintain training and certification requirements for the position and assist others to develop training content.
WHO YOU ARE
- Education: BSc in Chemistry, Biochemistry, Biology, or related life science discipline.
- Professional Experience: 4+ years of quality experience in a biologic, GMP, and manufacturing environment. Cell and gene therapy experience preferred.
- Go-Getter: You are independent, work with a sense of urgency, and have proven results in executing and operating quality assurance processes and systems.
- Effective Communicator: You have superior written and verbal communication skills. You are an active listener who can communicate to different audiences in diverse situations and have a proven record of motivating others to achieve improvement and operational results.
- Analytical Mindset: You have a data-driven mindset and approach to problem solving and drawing insights. You see potential challenges as opportunities to learn, grow, and apply creative solutions.
WHO WE ARE
Aspect Biosystems is a Canadian biotechnology company combining the power of microfluidics and 3D bioprinting to create bioprinted therapeutics. Our bold team of innovators and entrepreneurs have joined us from all over the globe to move the needle on 3D bioprinting and work towards a future where our technology is used to save lives and make people healthier.
We are endlessly curious and wildly passionate about what we do. Our team is always excited to learn and roll up our sleeves to make a difference in the ever-changing world of biotech. We believe that every person on our team is a key contributor to our success. If you are committed to make a real impact and accelerate the development of biotechnology, we want to hear from you!
The environment at Aspect is fast-paced, collaborative, ever-changing, and supportive. We are looking for team players who bring substantial expertise and competency in their field. We offer competitive compensation packages and benefits with excellent opportunities for personal growth and career development.
At Aspect Biosystems, we celebrate diversity and are committed to creating an inclusive environment for all employees. All aspects of employment including the decision to hire, promote, discipline, or terminate, will be 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.