Quality Assurance Specialist

4 weeks ago

Vancouver, Canada Aspect Biosystems Full time

Quality Assurance Specialist

**ON-SITE - VANCOUVER, BRITISH COLUMBIA /**

**PROCESS DEVELOPMENT /**

**PERMANENT, FULL-TIME**
- 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 procedures and communicate and resolve discrepancies with the process development team.
- Collaborate daily with process development during production, and testing, 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.
- Be the quality assurance expert and support cross functional groups on developing study protocols, reviewing data, completing root cause analysis, and implementing corresponding corrective and preventive actions.
- Examine deviations, product non-conformities, and GMP investigations to ensure adequate resolution and compliance with phase appropriate GMPs.
- Provide GMP expertise on change management, and oversee implementation of design, process, and material related changes.
- Support the batch disposition process by ensuring that all required documents are accurately and properly completed, including all batch related deviations.
- Assist in the development of critical raw material specifications and review and approve of incoming raw materials.
- Coordinate with GMP Support Manager in ensuring routine calibration of equipment. Oversee qualification of critical GMP equipment, and GMP area qualification.
- Complete internal and external audits in a phase appropriate manner, including documenting observations and overseeing the implementation of corresponding CAPAs.
- Maintain training and certification requirements for the position and assist others to develop training content.

**Who You Are**:

- ** Education**: Bachelors 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.
- ** 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.

**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

**WHY ASPECT?**
- 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.

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