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Pharmacy Quality Analyst (Kennett Square, PA) Join a healthcare organization focused on ensuring the highest standards of safety and quality in compounded medications across both sterile and non-sterile operations.
Job Responsibility:
Conduct thorough quality checks on compounded medications to ensure adherence to established standards and regulatory requirements
Apply Quality by Design (QbD) principles to improve product consistency and reliability
Develop, review, and update Standard Operating Procedures (SOPs) in alignment with current regulations
Train compounding staff in quality control practices, validation procedures, and SOP compliance
Investigate quality events, determine root causes, and implement Corrective and Preventive Actions (CAPA)
Implement and monitor process controls within the Quality Management System (QMS) to support continuous improvement
Lead validation and qualification activities for equipment, systems, and processes
Maintain detailed documentation for quality testing, validation work, and SOP management
Ensure compliance with USP, cGMP, and state board pharmacy regulations across both 503A and 503B operations
Prepare clear, concise reports and collaborate across departments to uphold quality standards
Requirements:
Bachelor's degree required
5+ years of experience in quality assurance, ideally in pharmaceutical or compounding environments (or 5-7 years QA experience in another regulated field)
Familiarity with QMS, QbD, CAPA processes, USP standards, and cGMP requirements