Canada's Michael Smith Genome Sciences Centre (GSC) at BC Cancer is an international leader in genomics, proteomics, and bioinformatics for precision medicine. By developing and deploying genome sequencing, computational and analytical technology, we are creating novel strategies to prevent and diagnose cancers and other diseases, uncovering new therapeutic targets, and helping the world realize the social and economic benefits of genome science
Learn more about how the GSC is Bringing Genomics to Life.
Why work at the GSC
As the first genome centre to be established within a cancer clinic, our story began by thinking outside of the box. From being the first in the world to sequence the SARS coronavirus during the 2003 global outbreak to publishing the first study demonstrating the use of whole-genome sequencing to influence personalized cancer treatment planning in 2010, our passion for pushing scientific frontiers continues to this day.
Our technology platforms enable the transformative science being done at the GSC, but it is our world-class team of scientists and innovators that make it happen. By joining the GSC you will become part of a diverse and dedicated group of biologists, bioinformaticians, computer scientists, computational biologists, biochemists, engineers, and clinicians. We look for people who share our core values—science, timeliness, and respect—to join us in our mission to provide genomics, bioinformatics, and proteomics technology and expertise for the benefit of human health and society.
We believe that diversity and inclusivity are essential for the advancement of human knowledge and science. We welcome all applicants and provide all employees with equal opportunity for advancement, regardless of race, colour, ancestry, place of origin, political belief, religion, marital status, family status, physical or mental disability, sex, sexual orientation, gender identity or expression, age, conviction of a criminal or summary conviction offence unrelated to their employment.
All qualified candidates are encouraged to apply; however, Canadian citizens and permanent residents will be given priority.
*Due to COVID-19 restrictions, the position may require working remotely. This restriction would be re-evaluated upon re-contracting*
In accordance with the Mission, Vision and Values, and strategic directions of Provincial Health Services Authority patient and employees safety is a priority and a responsibility shared by everyone at PHSA, and as such, the requirement to continuously improve quality and safety is inherent in all aspects of this position.
Reporting to the Head of Quality and Regulatory Affairs or designate, the Quality Assurance Specialist ensures that the manufacturing and delivery of clinical products and diagnostic data at BC Cancer immunotherapy program and the GSC meets applicable quality and regulatory standards to facilitate the provision of quality clinical trial products and accurate, actionable sequencing reports to clinical sites, physicians and other scientific collaborators. The Quality Assurance Specialist applies scientific, clinical and technical knowledge to bring a comprehensive quality perspective to the manufacturing and high throughput production sites, assisting with developing manufacturing protocols and delivering training material to manufacturing and production staff , creating and deploying quality procedures, defining and producing reports and supporting efficient change request processes. The Quality Assurance Specialist provides feedback and advice to BC Cancer immunotherapy manufacturing and high throughput sequencing sites to promote continuous improvements in product manufacturing and data quality. The Quality Assurance Specialist assists with budget development by monitoring expenditures in relation to performance outcomes.
- Implements, evaluates and maintains the Quality Management processes and procedures for the BC Cancer’s immunotherapy clinical trial program and GSC’s clinical and production operations under the supervision of the Head of Quality and Regulatory Affairs or a designate. The Quality Assurance Specialist exercises initiative and independent judgment in the performance of these duties.
- Reviews clinical trial product manufacturing batch records, patient sample information and data collected during product and data delivery to ensure that all manufacturing and production steps are correctly executed, appropriate clinical labels are applied, confidential information is appropriately classified and de-identified by applying both clinical and technical perspectives and using quality standards to guide decision-making. Makes any required changes in the release processes to consistently promote a high level of product quality to facilitate the provision of quality product and data delivery.
- Reviews change requests submitted by the manufacturing and production staff for quality assurance to promote accuracy and completeness of requested change information and facilitates timely and efficient completion of approved changes by the quality systems group.
- Defines, creates and provides regular reports on quality activities and provides the reports to enable continuous quality improvement in the areas of product and data quality non-conformance reporting and follows-up on CAPAs and change requests. Consults directly with manufacturing and production group leaders, project managers and other senior level staff to promote the application and integration of findings into quality improvement efforts.
- Works collaboratively with the manufacturing, team, laboratory operations and project management team to develop, revise, deploy and deliver training and education to staff at all levels on quality systems, GMP, DAP and ISO standards and to define and develop summary reports and identify opportunities to improve quality system processes.
- Participates in system testing and other quality assurance processes to facilitate system upgrades and improvements, providing clinical product and data quality perspectives.
- Leads small projects that involve manufacturing and production staff at GSC and BC Cancer immunotherapy program, applying basic project management methods, using a quality improvement model and reporting to the Head of Quality and Regulatory Affairs and other Group Leaders as required on project status.
- Assesses the effectiveness of QMS and identifies key opportunities for improvement in accordance with GMP/GLP and other applicable quality/regulatory standards and guidelines.
- Reviews and edits validation protocols to ensure alignment with GMP and GLP practices in order to ensure regular compliance for equipment, analytics methods, and production process in support of manufacturing operations.
- Supports the preparation of regulatory submissions such as clinical trial applications and amendments as required through the gathering of data and information, completing forms, reviewing and providing guidance to those writing submissions.
- Participates in the development of appropriate quality control program to ensure conformity of raw material, purchased reagents and material, and final products to quality standards.
- Conducts root-cause investigations associated with deviations, non-conformances, and failures through interviews, process review and root cause analysis, summarizes findings, and recommends follow-up and or/corrective actions. Performs quarterly and annual CAPA reviews.
- Hires, trains, and supervises staff as needed by establishing employee responsibilities, workload assignments and schedules. Completes staff performance reviews.
- Assess Quality service level requirements and participates in developing essential services plans on behalf of management in preparation for job action.
- Applies risk assessment methodologies to evaluate new process, process change implementations and new suppliers and vendors. Performs annual risk assessments and maintains a risk catalogue.
- Frequently travels to other immunotherapy manufacturing worksites as needed to release clinical products for patient management
- Other related duties as necessary.
A level of education and experience equivalent to a Bachelor’s degree in a scientific field (eg Biology, Engineering, Nursing) and a minimum of 3 years of experience combining direct QA/QC experience in the GMP compliant pharmaceutical/biotech environment executing risk assessments, quality control assays, process improvements and non-conformance investigations.
Skills required include strong verbal and written communication skills, excellent interpersonal skills, attention to detail and accuracy in work, strong computer skills, including familiarity with MS Office products and use of the Internet. A strong working knowledge with equipment qualification, test methods and other processes related to GMP/GLP practices. Experience with data quality assurance work is preferred, as is familiarity with reporting software products. Excellent organizational and time management skills and clear, concise writing and proof-reading skills. Ability to interact constructively and efficiently in a cross functional team environment. Capacity to independently manage multiple priorities in a fast-pace manufacturing environment. Flexibility and a commitment to self-directed learning are also important skills, combined with the ability to remain calm under pressure. An appreciation and respect for the sensitive and confidential nature of the data is also critical. Knowledge of clinical trials in Canada, cell therapy, genomics, immunology and/or immunotherapy would be considered a plus.
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