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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 Duties

• 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.

Details

• Location: Kennett Square, PA

• Schedule: Monday-Friday, 8:00am-4:30pm

• Pay Range: $23.00 - $25.00/hr.

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