Quality Auditor - GxP (Pharmacy Compounding/503B)

📋 Description

• • As a Quality Auditor - GxP (Pharmacy Compounding/503B) at Premier Inc., you will play a critical role in safeguarding patient and member safety by ensuring outsourcing facilities, pharmaceutical testing laboratories, and related suppliers comply with stringent CGMP and 503B regulatory standards. Your work directly supports Premier’s mission to improve healthcare quality and safety through rigorous, evidence-based auditing practices that drive continuous improvement across the pharmaceutical supply chain.
• • On a day-to-day basis, you will: Build comprehensive audit plans, agendas, and document requests using Premier’s internal inspection frameworks, aligning scope with stakeholders and program goals to ensure thorough and targeted evaluations; Conduct onsite GxP audits at outsourcing facilities and laboratories, performing facility walkthroughs, process witnessing, and records review across quality systems including deviations/CAPA, change control, training, equipment validation, environmental monitoring, cleanroom controls, and sterility assurance, while interviewing personnel and observing practices against FDA CGMP and applicable USP standards; Author clear, objective, and defensible audit evaluation summary reports that document observations with supporting evidence, provide actionable recommendations for compliance or improvement, and engage suppliers in finalizing reports to ensure understanding and closure of findings; Perform ongoing quality reviews by analyzing supplier quarterly quality reports, synthesizing findings, tracking recommendations, and maintaining updated risk assessments to support proactive supplier management; Contribute to continuous improvement initiatives by maintaining current knowledge of evolving CGMP, FDA, and USP guidance, refining internal audit tools and templates, and sharing best practices to enhance audit effectiveness and consistency across the team.
• • You will be part of Premier’s Healthcare Management Consulting team, a nationally recognized leader in healthcare quality, safety, and performance improvement, consistently ranked among the nation’s healthiest and most ethical employers. This team partners with healthcare providers, manufacturers, and suppliers to elevate standards of care through data-driven insights, regulatory expertise, and operational excellence, offering a collaborative environment where your auditing expertise will directly influence national healthcare quality initiatives.
• • In this role, you will deepen your expertise in pharmaceutical quality systems, regulatory compliance, and audit methodology while developing advanced skills in risk-based auditing, technical writing, stakeholder engagement, and continuous improvement leadership. You will have the opportunity to influence supplier quality practices across the 503B outsourcing sector, gain recognition as a subject matter expert in sterile compounding audits, and grow professionally within a company that invests in employee development through tuition reimbursement, professional training, and clear career progression paths.