Position Summary:
* Support quality initiatives and be an advocate for quality throughout the company
* Maintain electronic Quality Management System
* Respond to daily quality issues including representing Quality in various meetings
* Assist in leading initiatives and maintaining quality systems in accordance with applicable regulatory standards (i.e., ISO, CAP/CLIA, GxP)
* Assist in preparation for and hosting client audits and annual surveillance audits
* Collaborate with colleagues to audit, identify and correct quality issues and improve internal processes
* Develop procedures, job-aids and other controlled documents
* Perform trend reporting of non-conformances, supplier issues and customer complaints etc. to track KPIs and flag quality concerns to be presented to department managers and executives
* Review and support investigations/CAPAs of non-conformances, supplier issues and customer complaints and recommend corrective actions
* Support to departments during implementation of quality tasks.Educate employees on Quality Management System through training and presentations
* Respect the privacy of the personal information of patients, co-workers, and all individuals with whom the Company interacts
* Ensure compliance with all laws and regulations applicable to the Company and its operations
* Other duties as assigned by supervisor. These may, on occasion, be unrelated to the position described here.
* Consistent and predictable availability during our normal business hours is an essential function of the position.
Education Requirements:
* Bachelor's degree preferred, with major in life sciences desirable
* Apprenticeship in natural science (Technical Assistant or an equivalent qualification) will be considered
Qualification/Experience:
* At least two years' professional work experience, preferably in the Quality Management field
* Experience supporting a business is preferred.
* Experience with internal and external audit processes preferred
* Excellent computer skills, including Microsoft Excel, Word and PowerPoint
* Strong attention to detail with excellent organizational skills and the ability to prioritize multiple tasks
* The incumbent must show effective communication skills and ability to collaborate.
* Able to work independently as well as in an in-person and virtual team setting
* Excellent English verbal and written communication skills