What are the responsibilities and job description for the QMS Specialist position at United Consulting Hub?
QMS Specialist – Role Description
Position: QMS Specialist
Work Mode: Remote
Role Overview:
A QMS Specialist is responsible for supporting the execution of remediation activities across Quality Management System (QMS) workstreams including CAPA, Management Controls, Document Controls, and Training. The role works under the guidance of the Strategic Workstream Lead and collaborates with cross-functional teams to strengthen and implement compliant QMS processes across multiple sites.
Key Responsibilities:
- Execute day-to-day remediation activities across QMS workstreams such as CAPA, Document Control, Training, and Management Controls.
- Collaborate with lead-level staff and strategic workstream leads to redesign and implement improved QMS processes.
- Support Remediation CAPA core teams in addressing quality issues and ensuring effective corrective and preventive actions.
- Participate in root cause analysis (RCA) to identify underlying issues and recommend sustainable solutions.
- Assist in implementing robust quality management processes aligned with regulatory requirements.
- Deliver training and consultation on quality management principles to cross-functional teams across multiple sites.
- Ensure compliance with FDA regulations and applicable ISO standards.
- Manage multiple concurrent remediation tasks while maintaining quality and timelines.
- Communicate effectively with stakeholders across various organizational levels.
Required Skills & Knowledge:
- Strong understanding of Quality Management System (QMS) fundamentals
- Knowledge of FDA regulations and ISO standards
- Experience with CAPA, document control, and training systems
- Ability to perform root cause analysis and process improvement
- Strong communication and cross-functional collaboration skills
- Capability to manage multiple tasks and priorities in a remote environment