The Quality Specialist supports key Quality Management System processes by conducting investigations, and overseeing several quality processes, including batch release. The Quality Specialist oversees DNA Genotek’s equipment calibration and preventive maintenance (PM) programs.
Oversee the equipment Calibration and Maintenance Program. Organizes external equipment calibration and maintenance
Prepares metrics for various quality measures
Formal review of batch records and lab reports
Performs final release of chemistries formulated at DNA Genotek.
Reviews, provides quality guidance on and approves standard operating procedures and work instructions, change requests, Internal FMEAs, validation/verification protocols and reports of chemical production processes and lab related equipment.
Reviews and provides guidance on internal CAPAs related to internal equipment and production processes.
Analyzes quality trends for continuous improvement opportunities
Initiates Nonconformance Reports, performs internal investigations and assigns CAPAs related to DNA Genotek equipment and internal batch record nonconformities
Participates and supports the change management process for released internal products and established processes
Supports design reviews of internal products
Other duties as assigned and deemed appropriate for a Quality Specialist.
Diploma or degree in chemistry or biological science or equivalent combination of relevant job experience and training.
Diploma or degree in Biomedical Engineering or equivalent combination of relevant job experience and training
Certification in Quality Auditing, Quality Engineering or Quality Management an asset.
Minimum 3 years in quality control or quality assurance role.
Excellent English communication skills, verbal and written
Experience analyzing technical data and preparing technical reports.
Knowledge of quality management systems such as ISO9001, ISO13485 and cGMP.
Knowledge of ISO 17025 requirements
Experience with quality tools to solve problems
Experience in problem solving: demonstrated structured approach to solving problems (root cause analysis, design of experiments, statistical analysis)
Experience in equipment calibration and/or preventive maintenance
Experience in reviewing batch records and/or performing lot release
Demonstrated resourcefulness and ability to work with a diverse set of tasks and responsibilities.
Proficiency in MS Office Applications
Meticulous attention to detail
At DNA Genotek, we are committed to building and preserving an accessible, welcoming, supportive, fair, and inclusive environment. Accommodations are available to support prospective employees during the recruitment and hiring process. Should you require any accommodations, please advise us in advance so that we can work with you to find a suitable accommodation.