Quality Assurance Coordinator

The Quality Assurance Coordinator supports the Lions World Vision Institute (LWVI) quality management system to ensure compliance with regulatory requirements, including federal, state and local laws, as well as professional associations and industry standards.

• Maintain current knowledge of FDA, AHCA, OSHA regulations as well as AATB and EBAA standards; keep informed on industry changes, trends and best practices.
• Assist with the development and implementation of compliance-related policies and procedures throughout the organization.
• Maintain documentation of LWVI’s comprehensive training program to ensure consistency and compliance with internal SOPs and regulatory requirements.
• Assist with the execution of periodic internal quality audits of activities related to critical areas of operation as defined in LWVI SOP.
• Assist with the execution of periodic external audits of suppliers, service providers, contract laboratories, and other organizations performing a manufacturing step on behalf of LWVI.
• Review quality control documentation, including facility and equipment records for compliance with internal SOPs. Assist with quality control functions, including but not limited to, the execution of environmental monitoring and process validation activities.
• Assist with documentation of LWVI’s adverse event tracking system for Occurrences, Departures from Procedure and Adverse Reactions. Ensure that each event is properly investigated, evaluated for impact, and reported to regulatory agencies as needed.
• Assist with implementation of approved corrective action plans including tracking corrective actions to completion and closure and monitor compliance systems to ensure their effectiveness.
• Provide assistance during regulatory and accrediting agency inspections or external organization audits.
• Perform other duties as assigned.

• Must have strong verbal, written and analytical skills.
• Demonstrated quality auditing skills and experience preferred.
• Must have demonstrated computer skills, including Microsoft Office applications, including Word, Excel, PowerPoint and Outlook.
• Demonstrated technical writing skills preferred.
• Exhibit a high degree of professionalism and etiquette.
• Must have demonstrated ability to effectively deliver presentations and training.
• Must be able to effectively work independently and within a team.
• Able to manage both time and priority constraints and to manage multiple priorities simultaneously.
• Be a self-starter and perform work independently.

• Bachelor’s degree from an accredited four-year college or university required.
• Minimum 1-year experience in quality or regulatory experience, including auditing, preferred.
• Experience with interpretation and practical application of FDA regulations, procedures and guidelines that govern quality systems is preferred.
• Experience in process and equipment validation, technical writing, and organ and tissue services quality systems, is preferred.
• Knowledge of eye, tissue or organ transplantation operations is preferred. Certifications in these areas, such as CEBT or CTBS, preferred.
• Paid time off with a starting maximum of 144.04 hours per year.
• 8 Company-paid Holidays per year.
• Medical, Dental, and Vision plan offerings for employees and their eligible dependents. All Vision plans 100% employer-paid.
• Employer-paid Employee Assistance Program, Life, Accidental Death & Dismemberment, Short-Term Disability, and Long-Term Disability plans.
• Offerings of Supplemental Life and Accidental Death & Dismemberment for employee and their eligible dependents.
• An employee may voluntarily designate a percentage of their salary towards employer-sponsored 401(k). LWVI will match the employee's contribution up to 6% of the employee's salary.
• Discounts on Pet Insurance and other items such as phone plans, movie tickets, etc.

The Quality Assurance Coordinator will periodically be required to travel by personal or company automobile or air to meeting sites and other locations. Forty-hour work week. Must be available evenings, weekends, and holidays, as required.

The work…