Quality Assurance Coordinator

Position Purpose

The Senior 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. This position provides senior-level technical support and oversight of quality activities, including internal auditing, investigations, training and competency, document control, process improvement, and assigned quality programs. The Senior Quality Assurance Coordinator also serves as a resource and mentor to Quality Assurance Coordinators and supports the development and implementation of quality system training.

Hybrid Schedule

• Required to be in-office on Wednesdays.

Essential Duties and Responsibilities

• Maintain current knowledge of FDA, AHCA, OSHA regulations as well as AATB and EBAA standards; keep informed on industry changes, trends and best practices.
• Coordinate document control and change management activities to ensure changes are appropriately reviewed, approved, implemented, and documented.
• Maintain documentation of LWVI's employee training and initial/annual competency records to ensure records are complete, current, and compliant with LWVI SOPs and regulatory requirements. Provide oversight of training documentation and identify training or competency gaps requiring follow-up.
• Develop, update, and deliver quality assurance training and educational materials, including training for new Quality Assurance Coordinators and other employees as assigned.
• Serve as a lead auditor for assigned internal quality audits. Plan, coordinate, and perform audits of operational activities; document findings; communicate results; and ensure appropriate follow-up is completed.
• Assist with the occurrence process, including monitoring and evaluating occurrences, ensuring appropriate categorization and escalation, initiating/completing investigations, determining when corrective and/or preventive actions (CAPAs) are needed, tracking CAPAs through completion and closure, and monitoring and trending occurrences to identify recurring issues and opportunities for improvement.
• Initiate and complete investigations and documentation for departures from procedure, adverse reactions, tissue recalls, withdrawals, and other quality events, as assigned.
• Serve as the primary Quality Assurance resource for the long-term storage program and provide oversight of program activities, documentation, compliance, and follow-up.
• 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. Perform or assist with quality control functions, including environmental monitoring and process validation activities.
• Lead or participate in process improvement initiatives that support quality, compliance, efficiency, and consistency across the organization.
• Perform all required follow-up documentation for confirmed positive infectious disease results.
• Maintaining proper equipment documentation. Including generating and reviewing IQ, OQ, PQ’s for all LWVI offices.
• Responsible for maintaining an overall knowledge of all operation processes, including referral, recovery, donor eligibility, processing, and distribution.
• Involvement with an industry professional society (eg through membership of a committee or council)
• Perform other duties as assigned.

Knowledge, Skills and Abilities

• Must have strong verbal, written and analytical skills.
• Effective interpersonal skills: ability to develop and maintain positive relationships with professional contacts, resources and/or networks and deal with people with sensitivity, tact, discretion and professionalism.
• Experience with Microsoft Office Programs including: Word, SharePoint, Teams, Excel, Visio, etc.
• Strong investigative and problem-solving skills.
• Exhibit a high degree of professionalism and etiquette.
• Must be able to effectively work independently and within a team.
• Able to manage time and prioritize constraints as well as the ability to manage multiple priorities/tasks simultaneously.
• Outcome driven; can thrive in a fast-paced environment while effectively managing pressure in a professional manner.

Education and Experience Required

• Bachelor’s degree from an accredited four-year college or university preferred.
• Minimum of 3 years experience in quality or regulatory within tissue and/or eye banking preferred.
• Experience with the interpretation and practical application of FDA regulations, procedures, and guidelines that govern quality systems is preferred.
• CEBT, CTBS, or Quality Assurance certification required.

Schedule and Travel

The Senior 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.

Work Environment

The work environment described here is representative of those employee encounters while performing the essential functions of the job. While performing the duties of the job, the employee is exposed to a laboratory‐like environment and office like‐environment. The noise level is usually low. Open discussions about donor health and circumstances of death occur throughout the day. Equipment required for this position include but are not limited to, standard office space and equipment, standard PC equipment, printers, and telephone and/or headset.

Professional Appearance Standards

We are proud to foster a workplace that balances professionalism with personal comfort. Team members are expected to maintain a business casual appearance that reflects a clean and polished image.

Our standards permit:

• Natural hair colors
• Visible tattoos that are appropriate in nature
• Simple piercings, such as ear piercings and nose studs

All other piercings are not permitted during scheduled work hours; however, clear retainers may be worn in place of metal jewelry. Please note that certain roles may require designated uniforms or safety attire in accordance with job duties.

If you are comfortable adhering to these guidelines, we encourage you to apply. We look forward to welcoming motivated and professional individuals to our team.

As an equal opportunity employer, every qualified applicant will be considered for employment. Lions World Vision Institute does not discriminate based on race, color, sex/gender, political ideology, religion/creed, pregnancy, age, physical or mental disability, medical condition, genetic information, marital status, national origin, color, military or veteran's status, sexual orientation, gender identity, or any other status or characteristic protected by local, state, or federal laws. Lions World Vision Institute is committed to a diverse workforce and is also committed to a barrier-free employment process. In order to ensure reasonable accommodations with Title I of the Americans with Disabilities Act of 1990, individuals that require accommodations in the job application process for a posted position may contact us at for assistance. Lions World Vision Institute will use E-Verify once you have accepted the job offer and completed the Form I-9.

Current LWVI Employees should also contact the Human Resources department to notify them of your submission.