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Pharmacy Quality Assurance Analyst

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Beacon Hill

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Location:
United States , Kennett Square

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Category:
Pharmacy

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Contract Type:
Not provided

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Salary:

23.00 - 25.00 USD / Hour
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Job Description:

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

Additional Information:

Job Posted:
January 06, 2026

Employment Type:
Fulltime
Work Type:
On-site work
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