Quality Specialist

• Ensure the quality of IT Validation & Compliance infrastructure in a Contract Development and Manufacturing Organization (CDMO) setting
• Review and approve enterprise software validation lifecycle deliverables
• Provide global oversight of enterprise software validation
• Review and approve enterprise software change controls, CAPAs, and deviations
• Support the global data integrity initiative
• Provide strategic and technical expertise on global software validation matters
• Ensure compliance with cGMPs, legal and regulatory requirements, and KBI internal requirements

Principal Specialist – Quality Validation

• Ensure compliance with Council on Accreditation (COA) standards and prepare for COA surveys
• Assist with organization-wide policy and procedure updates and distribution
• Develop Performance & Quality Improvement forms for communication across departments
• Develop rapport with stakeholders and assist leadership with correspondence, collaboration, tracking and follow-up on compliance concerns
• Create and disseminate reports and notices throughout the agency
• Serve on CQI sub-committees as assigned
• Attend and facilitate business unit CQI team meetings
• Attend trainings relevant to job responsibilities and professional growth
• Conduct regular internal monitoring of assigned programs
• Complete Internal Monitoring tools and Exit Summary reports
• Conduct audits, follow up on internal and external audits, and ensure follow-through on plans of correction
• Monitor safety and quality, staff supervision, documentation, and training effectiveness
• Ensure agency, state, and federal guidelines are upheld
• Support preparation and readiness for program-specific external audits
• Serve as Incident Reporting Liaison to managed care organizations contracted with Thompson
• Facilitate Intervention Review Committee meetings to review incident data
• Track and monitor Level II and Level III incidents
• Assess patterns, environmental factors, and trends contributing to increased restrictive interventions in residential programs
• Assist with internal investigations of client rights violations
• Perform other duties as assigned

Quality Specialist jobs in North Carolina

Principal Specialist – Quality Validation

Quality Improvement Specialist