We are seeking a Quality Control Microbiology Analyst to complete routine QC microbiology sampling and test the GMP clinical manufacturing facility for Aspect’s bioprinted cell therapies. You will collaborate cross-functionally on quality tasks such as OOS/OOT, deviations, change controls, and risk assessments. As a subject matter expert in microbiological testing, you will provide support and validation of microbiological methods and demonstrate functional accountability through a cooperative and collaborative approach.
What You’ll Do
Maintain schedules for lot release testing, incoming materials testing, and environmental monitoring activities.
Oversee and execute routine QC microbiology testing such as endotoxin, bioburden, sterility, and other tasks as needed.
Complete environmental, utility, and product excursion investigations (Alert, Action, and OOS).
Generate reports and analyze trends from the environmental and utility monitoring data.
Maintain Standard Operating Procedures and other relevant control documentation.
Peer review both internally and externally generated data.
Participate in cross-functional team activities such as the Environmental Action Team.
Support routine laboratory operations such as equipment cleaning, inventory control, and logbook management.
Participate in laboratory equipment qualification activities.
Ensure our QC microbiology operation workflows are optimized and assist with troubleshooting and continuous improvement activities.
Who You Are
Education: Bachelor’s degree in life sciences, engineering, or equivalent.
Professional Experience: 3+ years of experience in the GMP regulated biotech industry.
Aseptic experience: Working knowledge of applying aseptic techniques and experience with aseptic manufacturing (gowning qualification, aseptic process simulation).
Microbial Expertise: You have experience generating microbiological Standard Operating Procedures, technical documents, and investigations. You have a working knowledge of microbiological method verification and validation. Experience with rapid microbial methods is a strong advantage.
Detail-Oriented: You have outstanding attention to detail and process rigor. You take pride in your work and strive for excellence in the work you do.
Go-Getter: You work with a sense of urgency, and have proven results in executing quality control processes and systems.
Collaborative: You thrive in a team environment and believe that we can get further faster by working together.
Analytical Mindset: You have a data-driven mindset and approach to problem solving and drawing insights. You have experience with data review and presenting results to key stakeholders. 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!
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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