Quality Assurance Coordinator

The ACTM Quality Assurance Coordinator works within the research environment of the Alberta Cell Therapy Manufacturing (ACTM), which aims to manufacture and market a variety of cell therapies in compliance with national and international Good Manufacturing Practices. 

The successful candidate will be responsible for the establishment of a Quality Assurance Program for the current Good Manufacturing Practice (cGMP) facility which is currently being developed. An in-depth knowledge of cGMP and regulations applicable to Health Canada, Food and Drug Administration (FDA) and international regulatory agencies is essential to the success of this endeavour.

Duties

• Develops a Quality Management Plan ensuring compliance with cGMP for operation of ACTM
• Collaborates with validation consultants to review and approve facility and equipment validation documentation during the development of the unit including participation in final validation activities
• Conducts independent monitoring of the facility and the entire production process, including review of batch records and associated documentation of batch release 
• Develops a GMP Document Management Program 
• Develops a Quality Systems Reporting Program including preparation of quarterly trend reports for management review detailing Quality Metrics 
• Develops and administers a laboratory safety program
• Develops training programs for equipment and facility operation and GMP compliance
• Is actively involved in all laboratory techniques including molecular biology and tissue cultures 

Qualifications

• The ideal candidate will have a Bachelor's degree in Science; equivalent combinations of education and experience will be considered; minimum post-secondary scientific diploma in medical/laboratory sciences
• 1 to 2 years experience in a regulatory lab setting preferred
• Certificate in Quality Assurance Management preferred
• Familiarity with current Good Manufacturing Practice (cGMP) regulations preferred
• Excellent communication skills (written and verbal)
• Previous leadership experience through critical decision making and the ability to prioritize preferred