Tekton Research

QA Engineer

• Review, revise, and manage company SOPs, processes, and policies annually
• Identify gaps in processes and implement improvements
• Liaise with Corporate Operations on employee training requirements and documentation
• Create, maintain, and enforce Quality Assurance Plans for all departments
• Lead or participate in critical projects supporting continuous quality improvements
• Manage the scheduling, performance, reporting, and follow-up of Internal QA Audits
• Lead and support sites during regulatory agency inspections and inquiries
• Develop and provide regular QA metrics reporting to leadership
• Assess QA growth and development needs based on company goals
• Provide guidance, interpretation, support, training, and input on regulations, guidelines, corporate standards, and policies
• Manage documentation, reporting, and closure of significant compliance issues
• Manage QA staff, including planning, assigning, and directing work, evaluations, and professional development
• Maintain current knowledge of industry trends, standards, and policies, including FDA, GCP, and EU requirements
• Perform other duties as assigned
• Reports to the COO

Head of Quality Assurance – Clinical Research