Quality Assurance Specialist

Quality Assurance Implementation

• Implement quality assurance plans and processes and identify indicators needed to assess product/service quality levels.
• Collaborating with management/functional experts or Sponsors to identify requirements of the organization in order to conduct internal audits, site audits, vendor assessments and vendor audits.
• Oversee the development of Quality System documents including policy, procedure, instruction, guidance and form and template development in collaboration with departments and senior management.
• Develop QA processes, train and oversee junior QA staff.
• Liaise with the Human Resources department to ensure that all staff are qualified.
• Remain current on and ensure internal awareness of regulatory trial conduct standards and requirements.
• Identify changes to standards and regulations governing Clinical Research and provide recommendations for implementation as required.

Regulatory, Ethical Conduct and Audit Monitoring

• Remain current on, interpret and communicate changes to regulatory trial conduct standards and requirements.
• Identify, implement and/or develop policies, processes, and/or training to meet these standards.
• Plan/lead/facilitate Sponsor and regulatory inspections and audit activities including preparation of staff, oversight of proceedings and ensure findings addressed are resolved.
• Perform internal audits and vendor assessments, ensuring that all observations are appropriately addressed and resolved.
• Communicate audit findings to internal stakeholders and provide guidance to teams regarding the development of Root Cause Analysis and Corrective Preventive Actions.
• Liaise with other departments in the completion of Sponsor requests for information.
• Support internal departments with privacy related questions or inquiries

Product/Service Consulting

• Provide guidance during product/service enhancements cycles or during times of organizational change around quality compliance and cross-functional process requirements and organization efficiency gains. 

Qualifications

• The successful candidate will possess either an undergraduate degree with 4-6 years of related experience and on the go training, or a College Diploma with 7-9 years of related experience and training.
• Life Sciences, Clinical Research, Information Technology or Clinical Quality Assurance specialty preferred. Strong analytical, critical thinking and problem-solving skills required. Knowledge of ICH GCP, global regulations governing Clinical Research and global privacy regulations.