VIDO
QA/QC Specialist
Description
The Vaccine and Infectious Disease Organization (VIDO), Canada’s Centre for Pandemic Research, is a world leader in infectious disease research and vaccine development for humans and animals. Located at the University of Saskatchewan in Saskatoon, Canada, VIDO is home to one of the largest and most advanced containment level 3 facilities in the world. To strengthen the preparedness for emerging infectious diseases we are currently expanding our infrastructure to include containment level 4 capacity, a GMP vaccine manufacturing facility, and a new animal housing facility. Our vision includes having the capacity to study any emerging disease in any animal model embracing a One Health approach to prevent emerging and re-emerging infectious diseases in humans and animals.
VIDO is seeking a highly skilled and detail-oriented QA/QC Specialist to join our Regulated Vaccine Manufacturing team. This role combines responsibilities in assay development, quality assurance, and quality control within our state-of-the-art GMP-compliant vaccine manufacturing facility. The successful candidate will contribute to the development, validation, and execution of assays, as well as ensure compliance with regulatory standards through rigorous Quality Control (QC) practices.
Key Responsibilities
- Develop, qualify, validate, and execute high-precision assays for vaccine production and batch release.
- Write protocols and reports, including data analysis.
- Perform raw materials testing, environmental monitoring, and QC release testing.
- Draft and revise SOPs, batch records, validation studies, and documentation.
- Maintain and calibrate specialized laboratory equipment.
- Participate in internal audits, training programs, and facility calibration.
- Supervise labeling, packaging, and shipping of final products.
- Ensure compliance with cGMP, Health Canada, and international regulatory standards.
- Support upstream microbiology and in-process testing during production runs.
- Conduct statistical analysis and data interpretation using Excel, JMP, Minitab, or R.
- Collaborate with cross-functional teams in a multi-product, multi-use Contract Development and Manufacturing Organization (CDMO) environment.
Qualifications
- BSc in Biological Sciences or related discipline, MSc is an asset
- Minimum 5 years of laboratory experience, including 2+ years in regulated biologics or sterile manufacturing.
- Experience in assay development, qualification, validation, and statistical analysis.
- Strong background in microbiology, molecular biology, and cell culture. Experience with chromatography an asset.
- Familiarity with Canadian Health of Animals Act, 9CFR, and Health Canada cGMP guidelines.
- Professional designation in Quality or Project Management is an asset.
Skills and Competencies
- Proficiency in working within regulated quality systems, complying with SOPs, and accurately and contemporaneously executing cGMP batch records.
- Excellent aseptic and analytical laboratory techniques, strong understanding of all relevant microbiological practices and biosafety standards.
- Experience in designing and executing protein stability studies.
- Strong interpersonal, communication, and team-building skills.
- Ability to work in a self-motivated and self-directed but collaborative fashion in a fast-paced environment.
- Proficiency with Microsoft Office, SigmaPlot, and Microsoft Project.
Work Environment & Safety
- Must be willing to work overtime and on a rotating schedule, which may include evenings and weekends.
- Must be willing to be vaccinated or tested for antibody titers for facility-manufactured products.
- Work involves biosafety level 2 and 3 organisms, hazardous materials, and high-pressure systems.
- Requires lifting to 15 kg and wearing cleanroom-specific PPE.
- No makeup or jewelry permitted in cleanroom environments.
Status: Permanent
Employment Group: Non-Union
Shift: Monday - Friday, 7.5 hours per day (37.5 hours per week), with ability to work flexible hours including evenings and weekends
Full Time Equivalent (FTE): 1.0
The successful applicant will be required to provide the following current verification(s) where 'Yes' is indicated below. Further information is available at: https://careers.usask.ca/tips-for-applying.php#Howtoapplyforaposition
Facility Access Screening including Criminal Record Check: Yes
Driver's License and Abstract Check: Not Applicable
Education/Credential Verification: Yes
Vulnerable Sector Check: Not Applicable
Interested candidates are asked to submit their application including a cover letter, CV, and the names of three references online. Review of applications will begin immediately; and will be accepted until the position is filled. We thank all applicants for their interest; only those candidates selected for an interview will be contacted.
For more information visit: vido.org
Note: The University believes equity, diversity, and inclusion strengthen the community and enhance excellence, innovation and creativity. We are dedicated to recruiting individuals who will enrich our work and learning environments. All qualified candidates are encouraged to apply; however, in accordance with Canadian immigration requirements, Canadian citizens and permanent residents will be given priority. We are committed to providing accommodations to those with a disability or medical necessity. If you require accommodation to participate in the recruitment process, please notify us and we will work together on the accommodation request. The University of Saskatchewan’s main campus is situated on Treaty 6 Territory and the Homeland of the Métis. We pay our respects to the First Nations and Métis ancestors of this place and reaffirm our relationship with one another. Together, we are uplifting Indigenization to a place of prominence at the University of Saskatchewan