Quality Coordinator

SandsRx • Plano, TX

1d

About The Position

The Quality Coordinator supports the organization’s quality assurance and regulatory compliance initiatives within a 503A compounding pharmacy environment. This role serves as the central communication liaison between pharmacists, lead pharmacy technicians, directors, and the Vice President of Compliance and Compounding Innovation to ensure consistent implementation of quality standards across all operations. The Quality Coordinato r is responsible for auditing quality control data, monitoring regulatory compliance, maintaining quality documentation, and supporting operational quality initiatives across sterile and nonsterile compounding activities. This individual plays a critical role in ensuring consistent communication, accountability, and execution of quality processes across teams and locations. This position requires strong leadership through a servant leadership approach, emphasizing compassion, accountability, collaboration, and support for pharmacy staff while maintaining the highest standards of regulatory compliance. Schedule and Compensation Compensation listed is not a fixed range; final rate will be determined based on the candidate’s experience, qualifications, and overall value. Schedule: Monday through Friday, 8:00 AM – 5:00 PM Travel Requirement: Approximately 30% to 50% travel to other pharmacy site locations

Requirements

• Experience in sterile and nonsterile compounding pharmacy environments.
• More than 3 years in sterile compounding experience
• More than 1 year in nonsterile compounding experience
• Understanding of USP <797>, USP <795>, and USP <800> quality and compliance standards.
• Experience reviewing quality data, environmental monitoring results, or QC documentation.
• Strong organizational and documentation skills.
• Proficiency with Microsoft Office (Excel, Word).

Responsibilities

• Quality Control Auditing and Reporting
• Audit and review quality control data, environmental monitoring records, and quality metrics to support compliance with internal standards and USP <797>, <795>, and <800> requirements.
• Analyze and trend quality data to identify potential risks, deviations, and opportunities for improvement.
• Prepare quality summaries, compliance reports, and performance updates for the Vice President of Compliance and Compounding Innovation.
• Maintain consistent communication with the Vice President of Compliance and Compounding Innovation regarding quality performance, risks, corrective actions, and improvement initiatives.
• Communication and Cross‑Department Coordination
• Serve as the primary point of communication between pharmacists, lead pharmacy technicians, directors, and the Vice President of Compliance and Compounding Innovation regarding quality and compliance matters.
• Facilitate information flow between production teams and compliance leadership to ensure alignment with quality expectations.
• Maintain open communication with designated lead technicians and pharmacists responsible for sterile and nonsterile operations.
• Quality Meetings and Leadership Coordination
• Coordinate and produce quarterly Quality Control and Quality Assurance meetings to review quality metrics, compliance trends, and improvement initiatives.
• Coordinate, lead, and initiate monthly quality meetings with sterile and nonsterile compounding teams.
• Document meeting summaries, track action items, and provide structured reports to the Vice President of Compliance and Compounding Innovation.
• Environmental Monitoring Oversight
• Monitor and trend routine environmental monitoring of cleanrooms and controlled areas, including air and surface sampling for microbial contamination to support compliance with USP <797>.
• Documentation and Compliance
• Maintain accurate and detailed records of quality control activities including environmental monitoring data, test results, and equipment calibration logs.
• Ensure proper documentation practices and consistent filing procedures according to Good Documentation Practices and leadership directives.
• Equipment Calibration and Maintenance
• Maintain calibration records and schedules for critical compounding and laboratory equipment including, but not limited to, laminar airflow workbenches, incubators, refrigerators, freezers, and analytical instruments.
• Investigations and CAPA
• Assist in investigations involving out-of-specification results, deviations, or environmental monitoring excursions and support the development of corrective and preventive actions.
• Training and Compliance Support
• Assist in training pharmacy staff on aseptic technique, gowning procedures, environmental monitoring practices, and USP <797> compliance expectations.
• Inventory Management
• Monitor inventory of QC testing supplies, reagents, microbiological media, and other quality-related materials.
• Regulatory Preparedness
• Support preparation for inspections by state boards of pharmacy, FDA, or other regulatory bodies by ensuring quality documentation and records are inspection-ready.
• Operational Support
• May assist sterile and nonsterile production teams when operational needs arise while maintaining compliance with quality and safety standards.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: No Education Listed
• Number of Employees: 1-10 employees