Specialist Jobs in Kansas City, MO

Reports to : Director of Quality Improvement and Regulatory Affairs

FLSA Status : Non-Exempt (Hourly)

Job Status : Full time

Location : Kansas City, Missouri

ABOUT US :

Saving Sight is a mission-driven organization that provides comprehensive and innovative vision preservation programs to communities and clinical partners. As a co-founder and business partner of Vital Tears, Saving Sight specializes in the production and distribution of autologous serum eye drops to patients in need.

POSITION PURPOSE :

The Quality Specialist ensures Vital Tears' compliance with regulatory standards by monitoring processes, identifying non-compliance, and collaborating with the Quality Assurance team to maintain adherence to FDA regulations and current Good Tissue Practices (cGTP) standards. This role also conducts internal audits, assists in investigations and supports continuous improvement initiatives.

ESSENTIAL DUTIES AND RESPONSIBILITIES :

• Monitor operational compliance with established protocols, policies, and quality standards, ensuring adherence to regulatory requirements.
• Support external audits by preparing required documentation and assisting with post-audit action plans to address findings.
• Assist with non-conformance and complaints management, including the implementation of corrective and preventive actions (CAPAs) to drive continuous improvement.
• Support environmental monitoring, equipment, and supply programs by ensuring proper documentation, calibration, and compliance with regulatory standards.
• Collaborate with operational teams to identify opportunities for process improvement while maintaining regulatory and quality compliance.
• Manage document control to ensure all quality-related documents are current, accurate, and compliant with internal and external standards.
• Contribute to the maintenance and improvement of the Quality Management System (QMS), aligning with organizational goals and compliance requirements.
• Conduct internal audits and risk assessments, such as Failure, Modes, Effects, Analysis (FMEA), to identify potential risks to product quality and patient safety, ensuring timely mitigation strategies are implemented.

QUALIFICATIONS AND EXPERIENCE :

EDUCATION REQUIREMENT :

PHYSICAL REQUIREMENTS :

ENVIRONMENTAL DEMANDS

NOTE : The preceding statements describe the nature and level of assignments normally given to job incumbents. They are not an exhaustive list of duties. Additional duties may be assigned.

Saving Sight is an Equal Opportunity Employer. We take pride in the diversity of our staff and seek diversity in our applicants. Saving Sight does not unlawfully discriminate on the basis of any status or condition protected by applicable federal or state law. Saving Sight reserves the right to seek, hire and promote persons who support the goals and mission of the institution.