Quality Assurance Technician

This position is a part of the Non-Academic Staff Association (NASA).

This position has a term length of one year plus one day with a possibility of extension and offers a comprehensive benefits package which can be viewed on our Benefits Overview page .

Location - Work primarily takes place at North Campus Edmonton.

Working for the University of Alberta

The University of Alberta acknowledges that we are located on Treaty 6 territory, and respects the histories, languages and cultures of First Nations, Métis, Inuit and all First Peoples of Canada, whose presence continues to enrich our vibrant community.

The University of Alberta is teeming with change makers, community builders, and world shapers who lead with purpose each and every day. We are home to more than 40,000 students in 200+ undergraduate and 500+ graduate programs, over 13,000 faculty and staff, 260,000 alumni worldwide and have been recognized as one of Canada’s Greenest Employers for over a decade.

Your work will have a meaningful influence on a fascinating cross section of people—from our students and stakeholders, to our renowned researchers and innovators who are quite literally curing diseases, making discoveries and generating solutions that make the world healthier, safer, stronger, and more just.

Working for the Department of Medical Microbiology & Immunology 

The mission of the Department of Medical Microbiology & Immunology is to provide an enriched environment for research, education and training in the field of infection and immunity that links molecular mechanisms to disease, treatment and prevention.

Position 

The Li Ka Shing Applied Virology (LKSAV) Group is recruiting a Quality Assurance Technician. This position is part of the QA/QC team (reporting to QA/RA Specialist) that regulates and ensures that the vaccine development meets internal Quality Management standards, as well as international regulations not limited to Health Canada and FDA and European cGMPs, USP, BP and ICH guidelines.

The successful candidate will be responsible for the maintenance of a Quality Assurance Program for the manufacturing of GMP products. An in-depth knowledge of Current Good Manufacturing Practice (cGMP) and regulations applicable to Health Canada, the Food and Drug Administration, and international regulatory agencies is essential to the success of this endeavor.

This is a very unique position for the university since it involves manufacturing for phase I/II trials human trials that will occur inside and outside of Canada, and will have to meet Health Canada, FDA, and European safety requirements.

Duties 

• Maintain a controlled document system including a change management system to address all types of changes that may affect product quality.
• Write and revise Quality System SOPs.
• Review all policies, SOPs, procedures, forms, master batch production records, protocols, reports, specifications and other records and procedures.
• Review manufacturing, environmental monitoring and quality control data for products prior to release of batches to client.
• Participate in the final release and disposition of manufactured products, which includes a review of manufacturing records such as batch records, quality control data, environmental monitoring records, deviations, equipment records and certificates of analysis.
• Ensure deviations, out-of-specification results, excursions, audit findings and complaints are investigated, root causes are identified, and effective corrective actions/preventive actions (CAPAs) are implemented.
• Perform internal audits as required.
• Perform line clearance as a regulatory requirement.
• Collaborate with staff to review and approve facility and equipment validation documentation.
• Maintain Equipment management program including reviewing equipment History files and PM/CAL schedule for compliance and developing IOQ and PQ documents as required.
• Interface with regulatory agencies as required; participate in compliance audits and conduct vendor audits.
• Review and update staff training records and ensure staff are trained according to their training matrixes.
• Supports continuous quality improvement through establishing and enforcing GMP, GLP, and internal AVI quality management systems.
• Other duties as required.

Qualifications

• Minimum diploma in Biology, Life Sciences, or a related field; Bachelor’s degree preferred.
• Minimum 5 years experience working in a GMP regulated laboratory environment including applying and complying with GMP regulations.
• Experience working in Quality Assurance or Quality Control.
• Experience writing and reviewing documents such as protocols, SOPs, study reports, and batch records.
• Experience in non-conformance investigation, reporting and follow-up.
• Experience in equipment, software, cleaning, assay, and process qualification/validation.
• Experience in managing employee training records.
• Experience in analytical development and validation, aseptic processing including hands on experience with aseptic technique.
• Attention to detail and sensitive to project timelines.
• Strong organizational skills, oral and written communication skills.
• Strong knowledge of Health Canada, FDA and ICH GMP Guidelines and how they apply to manufacturing sterile clinical drug products.
• Strong knowledge of the United States and British Pharmacopeias.
• Strong computer skills including knowledge of MS Word, Excel, PowerPoint, and Google Suite.
• Experience with using Data management software.
• Ability to work collaboratively in a team-based environment.

At the University of Alberta, we are committed to creating an inclusive and accessible hiring process for all candidates. If you require accommodations to participate in the interview process, please let us know at the time of booking your interview and we will make every effort to accommodate your needs.

Note: Online applications are accepted until midnight Mountain Standard Time of the closing date.

We thank all applicants for their interest; however, only those individuals selected for an interview will be contacted.