Quality Systems Specialist

GENERAL SUMMARY

The Quality Systems Specialist is responsible and accountable for compliance with US FDA regulatory
requirements, as well as company procedures and policies. This position is a key interface between all
functions within Intuvie Holdings which execute activities pertaining to 21 CFR Parts 820 and 803.

ESSENTIAL JOB FUNCTIONS*

Document Control:

• Oversee document lifecycle management, including creation, revision, approval, and archival of
• QMS records, policies, procedures, forms, and work instructions.
• Ensure compliance with document control processes and FDA regulations.
• Serve as a subject matter expert for electronic document management systems.
• Lead updates to QMS procedures, including SOPs, ensuring alignment with current regulatory requirements.
• Identify and implement process improvements to enhance operational efficiency.

Training Support:

• Coordinate training activities for newly implemented and revised QMS documents.
• Develop materials and resources to facilitate training and ensure compliance.

CAPA and NC Support:

• In conjunction with the CAPA process owner, and NC owner, assist in these processes to help ensure effectiveness.
• Provide coaching and advice in CAPA and NC excellence as necessary.
• Facilitate and guide CAPA and NC teams through the CAPA and NC processes including root cause investigations, risk assessments, solution planning, implementation, and verification of effectiveness.

Internal Audit Support:

• Collaborate with the Audit Process Owner to maintain accurate records in the Internal Audit Log and ensure timely completion of audit activities.
• Support the execution of internal audits and follow-up on findings.

Compliance Monitoring:

• Monitor regulatory changes and update relevant documentation as needed.
• Provide assistance with Quality Management Review preparations, including creating and maintaining metrics and reports.
• Contribute to FDA inspection readiness by supporting document requests and back-room activities.

OTHER DUTIES AND RESPONSIBILITIES

Perform additional duties as part of the Quality Systems team as required.