Senior Quality Assurance Specialist
Job Code: SQAS - 17-01-13
Reporting to the GSC Quality Systems Group Leader, the Senior Quality Assurance Specialist will support the manufacture, testing and development of Good Manufacturing (GMP) and Good Laboratory (GLP) practices compliant plasmids for the CAR-T immunotherapy clinical trial component at the GSC. In addition they will assist in the coordination and administration of the Quality Management System for the clinical and production operations at the GSC.
- Plans, develops, implements, evaluates and maintains the Quality Management Program, including policies, processes and procedures in cooperation with the GSC Quality Systems Leader for the GSC’s plasmid manufacturing operations that support the CAR-T immunotherapy clinical trial.
- Assesses the effectiveness and identifies key opportunities for improvement in accordance with GMP/GLP and other applicable quality/regulatory standards and guidelines.
- Provides support in developing validation protocols to ensure regulatory compliance for equipment, analytical methods, and production processes.
- Maintains a comprehensive change control and validation program for changes in pipelines, processes, equipment, reagents and consumables.
- Participates in equipment acquisition and qualification, and ensures equipment calibration, routine maintenance and testing activities are performed on schedule.
- Manages and controls documents and records, ensuring only current and valid documents are used, and obsolete or superseded ones are archived appropriately.
- Other activities may include supervision of quality staff, data analysis for quality trending purposes, maintenance of supplier files, among others
- Participates in the practical implementation of validated protocols and processes ensuring adequate training and SOPs are in place prior to commencing production.
- Maintains a comprehensive internal and supplier audit program, generates audit schedules and conducts audits as needed.
- Assists with the development of an 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.
- Identifies quality training needs and assists in developing and conducting training sessions for manufacturing and research staff.
- Supports the preparation of regulatory submissions as required through the gathering of data and information, completing forms, reviewing and providing guidance to those writing submissions.
A level of education, training, and experience equivalent to a Bachelor of Science Degree in Biology, Engineering or other related discipline and three to five years of direct QA/QC experience in the pharmaceutical/biotech environment.
Prior hands on experience with equipment qualification, test methods and other processes related to GMP/GLP practices. High attention to detail, 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. Skilled use of Word, Excel and other similar programs along with experience with an electronic Quality Management System or Laboratory management System is an asset. Knowledge of clinical trials in Canada, cell therapy, genomics, immunology and/or immunotherapy would be considered a plus.
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