Senior Quality Assurance Associate
Axiom Real-Time Metrics
Toronto, ON
The Senior Quality Assurance Associate is involved with the direct and daily administration of the Quality Management System, working closely with the Director, Quality Assurance and members of the Project Management, Data Management, Software Engineering, Product Management, and Customer Care teams. This is a full-time opportunity reporting to the Director of Quality Assurance.

Core responsibilities include:
Provide oversight of activities to ensure compliance with GxPs.
Prepares key quality documentation (deviations, change control, and CAPA documentation) that impact quality of products.
Review and approve GxP documentation including deployment records.
Liaise with internal groups to ensure detailed investigations and root cause analysis for non-compliance issues in a timely manner.
Aids in performing compliance audits in all departments and prepares results reports for Director, Quality Assurance. Ensures outstanding corrective actions from the audits to ensure timely corrective actions.
Demonstrates a primary commitment to product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.
Participate in the compilation of KPIs.
Oversee the compliance of the internal training process.
Investigates non-conformance’s to ensure recurrence is prevented.
Participates in special projects as required in other areas of Quality and Compliance as assigned by the Director, Quality Assurance
Perform other related duties as assigned.

Job Requirements Include the following:
Minimum 3+ years in a Quality Assurance role in either the pharmaceutical or clinical industry
Minimum 3+ years working experience in a QA Investigative Role
Prior work experience in Health Care Industry is essential..
Working knowledge of clinical trial process
Thorough knowledge of GxP
A good understanding of ISO:9001
Excellent oral, written communication, time management and organizational skills
Ability to work independently in a team environment
Proficient in Microsoft Word, excel, Power point, Project and Outlook
Strong attention to detail