Ensure that all pharmacy operations, processes, and products consistently meet established quality standards, regulatory requirements, and patient safety protocols
Assist in the development, implementation, and maintenance of the Quality Management System (QMS) for pharmacy services
Conduct routine and targeted internal audits of pharmacy processes, documentation, and product quality
Identify areas of non-compliance or potential risk and report findings to management
Collect, analyze, and trend quality data to identify patterns, evaluate performance, and inform continuous improvement efforts
Prepare regular quality reports for management review
Assist in developing and delivering training programs to pharmacy staff on quality standards, new procedures, and regulatory updates
Ensure all quality-related documentation is accurate, complete, current, and properly maintained
Proactively identify opportunities for process optimization and efficiency enhancements

High school Diploma or equivalent
2+ years of home infusion experience preferred
3+ years of experience in a quality assurance, quality control, or highly regulated environment, preferably within a pharmacy, healthcare, or pharmaceutical manufacturing setting
Capable of managing multiple priorities
Strong understanding of quality assurance principles, methodologies, and tools
Familiarity with relevant regulatory requirements (e.g., USP /, Joint Commission, CMS, HIPAA, state Board of Pharmacy) is highly desirable
Excellent analytical and problem-solving skills, with a keen eye for detail
Proficient in data collection, analysis, and reporting
Preferred
Advanced proficiency in Microsoft 365 and the Power Platform: SharePoint, Power BI, Power Automate
Strong written and verbal communication skills
Ability to work independently and collaboratively in a team environment
Expertise in Microsoft Office Suite (Word, Excel, PowerPoint, Outlook)
Strong organizational skills and the ability to manage multiple tasks effectively

Quality Assurance Specialist

Key skills