Quality Assurance Coordinator

Assists the Chief Quality and Compliance Officer with oversight of the Quality Management System (QA/QC, cGMP, cGTP, and cGLP), ensuring compliance with applicable federal and state laws, regulations, and accreditation standards.

Responsibilities

• Assist in promoting and maintaining a quality culture throughout the organization.
• Conduct internal audits of WU and CT/ET donor charts and apheresis collection charts.
• Ensure all department training is up to date and assign new training, as needed.
• Assist with investigation and resolution of deviations, complaints, and adverse reactions.
• Maintain QA-related documents and reports.
• Participate in continual improvement activities to enhance the Quality Management System across all departments (Donor Services, Apheresis Center, Cellular Therapy Laboratory, and Gift of Life Biologics).
• Develop a working knowledge of all areas of the organization and a clear understanding of key functional processes and resources.
• Fulfill other duties as assigned.

Requirements

• 1-3 years of experience in Quality Assurance.
• Knowledge of FDA cGMP (21 CFR 210 & 211) and CGTP (21 CFR 1271) regulations.
• Detail-oriented with strong documentation practices.
• Ability to manage and prioritize multiple projects and meet deadlines.
• Strong oral and written communication skills, with a focus on customer service.
• Ability to remain calm and tactful when resolving problems involving staff, visitors, vendors, etc.
• Problem-solving and decision-making skills.
• Flexible and adaptable to changing conditions.
• Project management skills.
• Knowledge, training, and experience in QA principles and data management systems.
• Understanding and monitoring of compliance with SOPs.
• Proficient in Microsoft Office Suite and other data management software.
• Strong time management, organizational skills, and ability to set priorities.
• Demonstrated ability to work independently and as part of an integrated team.

Schedule

This is a full-time, in-office position requiring 40 hours per week. Employees may choose either a 4-day, 10-hour schedule or a 5-day, 8-hour schedule.