Concordance Healthcare Solutions

General

• Support the cGMP compliant quality program for pharmaceutical storage
• Work in collaboration with Emergency Preparedness and Response Manager, Operations Manager, Program Manager, and Compliance Manager
• Maintain and enhance the quality management system (MasterControl)
• Ensure consistent quality practices across all distribution operations
• Serve as a functional member of the Quality team to manage MasterControl, including document control, training, change control, and other cGMP workflows
• Participate in the development, maintenance, and documentation of policies, procedures, and work instructions within the Quality Management Program
• Schedule, participate in, and review internal quality audits and related meetings
• Support external audits with customers, regulatory bodies, and third-party auditors and track audit findings with assisting in timely implementation and verification of corrective actions
• Serve as the internal point of contact for documenting and tracking ongoing performance issues
• Support root cause analysis efforts to help develop effective corrective and preventive actions (CAPA)
• Act as liaison with customers and vendors regarding quality issues, investigations, and corrective actions
• Conduct vendor qualification activities and review annual vendor requalification documentation
• Assist with future validations or revalidations of systems, equipment, or processes
• Verify Preventive Maintenance activities are completed in accordance with contractual agreements
• Collaborate with functional and departmental managers to support new programs and change management of existing processes
• Maintain and enhance the training reference material and training program by ensuring training assignments are current and completed for new hires and existing employees
• Perform additional responsibilities as assigned to support the Quality and Compliance program

Quality Coordinator