Quality Assurance Analyst - Compounding Laboratory

Job Summary

The Quality Assurance (QA) Analyst supports and maintains the Quality Management System (QMS) for the compounding laboratory. The role provides independent quality oversight of compounding operations, documentation, materials, equipment, facilities, and personnel practices to ensure compliance with approved SOPs, applicable quality standards, and regulatory requirements. The analyst works cross-functionally with Production, Quality Control, Pharmacy, Inventory, R&D, and Management to identify compliance gaps, investigate quality events, implement CAPAs, and promote continuous improvement.

Key Responsibilities

• Monitor compounding operations for compliance with approved SOPs, quality standards, and applicable requirements, including USP <795>; and USP <800>; as relevant.
• Perform routine QA inspections and internal audits of production, storage, packaging, labeling, and support areas; document observations and track corrective actions.
• Review controlled documentation and quality records for completeness, accuracy, traceability, and Good Documentation Practices (GDP).
• Document and investigate deviations, nonconformances, process failures, rework, rejected batches, and other quality events; support root-cause analysis and CAPA development, tracking, and effectiveness checks.
• Support change control for formulas, equipment, materials, suppliers, processes, facilities, systems, and controlled documents.
• Provide floor-level quality oversight of gowning, hygiene, cleaning, line clearance, material handling, labeling, equipment status, and production documentation.
• Verify appropriate receipt, identification, labeling, storage, status, and traceability of raw materials, including hazardous materials and materials requiring special controls.
• Support QA training, retraining, competency activities, product-quality complaint investigations, and audit readiness.
• Track quality metrics and trends, including deviations, CAPAs, complaints, rework, QC rejections, documentation errors, audit observations, and training compliance.

Qualifications

• Bachelor's degree in Pharmacy, Pharmaceutical Sciences, Chemistry, Biology, Microbiology, Quality Assurance, or a related scientific field preferred.
• Previous experience in pharmaceutical compounding, pharmacy operations, pharmaceutical manufacturing, or a regulated laboratory environment preferred.
• Knowledge of Quality Assurance principles and QMS; familiarity with USP <795>, USP <800>, GDP, CAPA, deviations, investigations, and change control preferred.
• Strong attention to detail, documentation, organization, analytical thinking, and problem-solving skills.
• Ability to identify compliance gaps, communicate findings professionally, and manage multiple quality activities simultaneously.
• Experience with non-sterile compounding, audit preparation, internal inspections, root-cause analysis, and electronic quality/document systems preferred.
• Proficiency with Microsoft Office and/or Google Workspace. Bilingual English/Spanish is a plus.

What We Offer

• Competitive salary.
• Opportunities for growth in a rapidly expanding telepharmacy practice.
• Collaborative and innovative work environment focused on patient safety and compliance.

Work Schedule

• 8:00AM to 5:00PM

This is a full-time position, working 44 hours per week, Monday through Friday This is a 100% onsite role; remote or hybrid work is not available.