Description
About You:
In this technical role, the QC technician will be responsible for assisting in the development and execution of Quality Control processes for incoming materials, in-process samples as well as final product to confirm the conformance of the product to the specifications. Working directly with the manufacturing team, this role will help define critical to quality characteristics and provide input on methods for inspection and testing as well as record review and documentation of inspection and test results. Duties include, but are not limited to, assisting with the development of incoming, in-process and final inspection processes and criteria; performing final acceptance inspections and/or testing on samples of batches of finished product; reviewing and approving batch records as well as developing work instructions for these activities.
What You’ll Do:
- Execute Quality Control activities in support of reagent and consumable manufacturing, performing in-process sampling inspection, where applicable, as well as final acceptance testing and batch record review and acceptance.
- As the Quality Assurance Subject Matter Expert, participate in manufacturing process development activities, providing recommendations on the best methods to confirm quality and consistency throughout the assembly process.
- Collaborate with Engineering, Manufacturing, Process Development and Assay Development teams to define inspection and test methods for incoming raw materials, in-process assemblies and reagent formulations as well as final acceptance of products (reagents and consumables).
- Support the Manufacturing team by performing final QC acceptance and release of batches of consumable assemblies, for use in Assay Development as well as clinical studies.
- Establish appropriate QC processes and controls to confirm consistency and quality of reagent and consumable manufacturing from prototype through production scale-up.
- Utilize your expert knowledge and experience to follow and recommend improvements to cGMP manufacturing processes and operations.
- Assist Supply Chain Management with supplier qualification and audit activities, as well as monitoring supplier performance by tracking and maintaining metrics around incoming material quality.
- Participate in process FMEAs and risk identification as well as recommending appropriate countermeasures.
- Create work instructions and record forms for QC activities.
- Establish and chair the Materials Review Board, a multi-disciplinary team that reviews and dispositions non-conforming materials.
- Provide input to, and review of, manufacturing equipment qualification and validation protocols and reports.
- Support and lead investigations for, Out-of-Specification (OOS) investigations, Quality Incident Notifications and CAPA actions related to manufactured product and manufacturing processes.
What You’ll Need:
- Bachelor’s degree in a technical field
- 5+ years of industry experience with specialized knowledge and experience in Quality Assurance in a cGMP environment
- Familiar with Quality Assurance processes related to the manufacture of reagents and consumables for IVDs, validation/qualification requirements, as well as instrument manufacturing;
- Excellent communication skills and attention to details;
- Strong organizational skills and ability to multitask across projects and activities;
- Proven ability to collaborate cross-functionally and participate on multi-disciplinary teams.
Bonus points for:
- Experience with lean and six sigma methodologies and their use in manufacturing;
- Prior experience with single use cartridge assembly and lyophilization processes would be welcomed;
- An appreciation of puns!
Why Join Us?
At Vital Bio, you will:
- Build the QC foundation that keeps our reagents and consumables reliable—from incoming materials through final product release.
- You’ll work directly with Manufacturing, Engineering, and Assay Development to define test methods, release criteria, and investigations that materially shape how we move from prototype to clinical and commercial production.
- As we scale, you’ll have the opportunity to lead key QC processes, drive improvements in cGMP operations and supplier quality, and see your work translate into products that support real-world patient care
Compensation will be determined based on the individual’s demonstrated experience, education, training, relevant certifications or licensure, and other applicable business and organizational factors.
This role is a current, onsite vacancy.
Vital is revolutionizing point-of-care diagnostics with our VitalOne platform, delivering real-time care wherever patients are. Our mission is to democratize health technology, making healthcare more accessible and proactive.
Our global team of experts spans chemistry, software, engineering, and microfluidics. We thrive on change, operate on trust, and value diverse perspectives. Our growth-minded culture empowers front-line decision-making and fosters impactful work.
We seek tenacious, bold individuals ready to transform healthcare. At Vital, your talent will make a difference as we work to ensure everyone has access to care when and where they need it.
Vital Biosciences Inc. is an equal opportunity employer and values diversity in the workplace. We are therefore happy to accommodate any individual needs in keeping with the Ontario Human Rights Code and the Accessibility for Ontarians with Disabilities Act. If you require accommodation in order to participate in our hiring process, please contact us to make your needs known in advance
As part of our recruitment process, we may use automated or AI-supported tools to assist with application review and screening. These tools are used to support, not replace, human decision-making. Final hiring decisions are always made by our hiring team.