Quality Specialist

• Assisting Quality Leadership with ensuring compliance and quality processes are maintained in support of clinical trial operational activities.
• Chief administrator for the quality management software (QMS).
• Leads and project manages QMS activities including document control, change control, non-conformance reporting and supplier qualification/requalification.
• Serves as team lead CSV specialist.
• Responsible for data reduction, metrics and managerial reports delivery.
• Supervise and assist in management of QMS Non-Conformance reporting and their related investigation, root cause analysis, proposed corrective and/or preventive measures, and due diligence thereto.
• Trains QMS users on workflow and associated tasks for modules within the QMS.
• Leads eQMS configuration and improvement specialist.
• Assesses, creates, and presents QMS Lean and Process Efficiency opportunities and projects.
• Assists management in assuring organizational readiness for regulatory inspections by scheduling, coordinating, conducting and documenting QMS module gap analyses.
• Provide industry leading QMS compliance guidance and quality assurance consultation to internal and external stakeholders.
• Clear and concise communication of QMS reporting for regulatory and quality consulting advisements.
• Schedules and conducts monthly quality review meetings as required.
• Prepare training materials and conduct training for QMS topics.
• Collaborates with Human Resources regarding training program requirements affected by the QMS.
• Serves as Quality subject matter expert for configurable systems validation projects.
• Conducts research, and compiles and types statistical reports.
• Performs other tasks as defined by the Quality Assurance Leadership.

Senior Quality Specialist managing QMS compliance for clinical trial operations

Senior Quality Specialist

Senior Quality Specialist managing QMS compliance for clinical trial operational activities. Leading quality management software initiatives and ensuring regulatory readiness across QMS processes.

• Conduct quality assurance reviews of designated draft Proof of Claim (POC), Motion for Relief (MFR), and Response to Notice of Final Cure (RNOFC) items routed through established workflow controls prior to finalization, focusing on accuracy, completeness, formatting, redaction, naming conventions, exhibit or attachment labeling, client-specific requirements, and overall quality.
• Complete quality control reviews of internal audits, including post-filing audits, for POC, MFR, Payment Change Notice (PCN), Post-Petition Fee Notice (PPFN), Agreed Order (AO), and other assigned document or process types.
• Review system completions and updates for accuracy, consistency, required documentation, and adherence to approved procedures and workflow expectations.
• Review client alert items as needed against applicable standards, workflow requirements, and documented instructions.
• Document review results, exceptions, and supporting details clearly in designated trackers, audit templates, systems, and/or workflow tools.
• Communicate identified issues to Quality Management leadership and appropriate operational contacts in a timely, professional manner; request clarification as needed to complete assigned reviews accurately.
• Follow approved QA/QC job aids, audit templates, sampling instructions, client requirements, policies, procedures, and escalation protocols.
• Assist with updates to review notes, job aids, audit templates, and process feedback as directed by Quality Management leadership.
• Protect and maintain the confidentiality of client, borrower, and firm information by complying with firm policies, data security protocols, privacy requirements, and all applicable laws and regulations.
• Exercise sound judgment when handling sensitive financial information and safeguard data against unauthorized access, disclosure, or misuse.

Quality Specialist ensuring compliance with legal procedures in a remote law firm.

Quality Management Specialist

Quality Specialist supporting assurance reviews and compliance checks for legal documents at Padgett Law Group, a creditors' rights firm. Conducting detailed audits and maintaining quality control standards.

• Serve as Vaya’s RHTP QAPI point of contact and manage & coordinate the development and implementation of internal QAPI activities and implementation of QAPI initiatives.
• Manage and coordinate the development and implementation of internal Quality Assurance Performance Improvement (QAPI) activities and implementation of Hub and/or governing board QAPI initiatives.
• Develop, implement, and evaluate QAPI processes and procedures to monitor and ensure the quality and timeliness of contracted Hub functions.
• Develop and implement stakeholder feedback tools. Gather reports from responsible individuals and other key staff; facilitate QI activities; and compile regular reporting for bi-directional flow of information among the Hub and governance body.
• Conduct regular review and analysis of quality and performance measures, surveys and assessments, incidents, and other data sources to identify quality and performance deficits.
• Design and implement Performance Improvement Projects (PIPs) and other QAPI processes to identify and address quality and performance issues.
• Provide support for the Hub to identify, aggregate, and report barriers to the governance body.
• Develop and strengthen processes to ensure compliance with and timeliness for required reporting, assessments and surveys, and other data submissions, and other required data submissions and reporting tools.
• Provide support as needed for Hub team members to develop and implement data collection tools and procedures to ensure all program requirements are met to support tracking, monitoring, reporting, and to evaluate and ensure the quality of Hub services and functions.
• Assist and support ongoing and ad hoc QAPI responsibilities of the Quality Management department.

Quality Improvement Specialist managing QAPI activities for Vaya Health

Quality Improvement Specialist

Quality Improvement Specialist managing QAPI activities for Vaya Health, ensuring quality assurance and improvement initiatives. Collaborating with teams to fulfill program requirements and support quality of services.

• Lead and organize training for all Quality Specialists on audit processes, procedures, and tools.
• Conduct complex audits and verifying quality standards for selected inquiries and make decisions whether discrepant information meets BCBSA and FEP audit requirements, state, and federal mandates.
• Provide second-level support on escalated issues and audit findings.
• Collaborate with team members, OCLD, and management to identify training gaps and business needs and implement actions while partnering to address these issues.
• Review, evaluate, and provide feedback on trainees’ audits and learning processes.
• Act as a consultant with external departments to help resolve high-impact business issues by recommending action plans related to quality assurance.
• Assist the Data Reporting Analyst in collecting data and providing analyses for various issues across the department and other functional areas.
• Foster a training and auditing culture that values diversity of thought, leveraging team member strengths to achieve team goals.
• Assist with external audits and lead special projects.
• Perform other duties as assigned.

Quality Specialist III ensuring compliance and conducting complex audits at Premera.

Quality Specialist III

Quality Specialist III role at Premera focusing on compliance, quality assurance, and auditing within healthcare services.

Quality Specialist jobs in Tennessee

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Senior Quality Specialist

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Quality Specialist III