Pharmacy Compliance & Sterile Product Coordinator

Children's National Hospital

12d • $116,646 - $194,418 • Onsite

About The Position

The Pharmacy Compliance & Sterile Products Coordinator ensures pharmacy compliance with current USP standards for sterile compounding (USP <797> and <800>) and non-sterile compounding (USP <795> and <800>). Under the direction of the Director of Safety & Compliance and Director of Pharmacy Compliance, the coordinator works with pharmacy compliance and operations leaders to maintain quality assurance programs and meet requirements established by USP, Boards of Pharmacy, the Department of Health, The Joint Commission, CMS, and other applicable accrediting and regulatory bodies.

The coordinator collaborates on developing and delivering employee training, establishing required SOPs and policies, and ensuring quality assurance activities are developed, completed, audited when applicable, and reviewed annually. The role maintains records, audits, and competencies related to compounding and regulatory compliance; contributes to strategy aligned with national standards and organizational policies; and serves as a subject matter expert on USP standards. The position is expected to use data to guide recommendations and improvements.

The role also supports strategic planning, compliance management, and quality and performance improvement through documentation, policy and SOP development, deviation tracking and response, audit preparation, and collection, analysis, trending, and presentation of quality data. It maintains records and interprets results for viable and non-viable sampling, documenting deviations and explanations for audit review.

Requirements

• Doctor of Pharmacy (PharmD) from an accredited School of Pharmacy.
• At least 5 years of pharmacy practice experience, including a minimum of 3 years in a hospital setting.
• 1 year of supervisory experience or 2 years of administration/team leader experience.
• Strong working knowledge of accreditation standards and regulatory requirements from various agencies.
• Proficiency in compiling and analyzing data to support upper-management decision-making.
• Pharmacist licensure in the District of Columbia.

Responsibilities

• Contribute to short- and long-term strategic planning for department services.
• Implement the strategic plan to improve pharmacy department compliance measures.
• Ensure compliance with organizational and departmental policies and procedures and regulatory standards.
• Maintain accurate pharmacy records and documentation required by regulatory standards.
• Work with upper management to maintain compliance among pharmacy department staff.
• Identify opportunities to improve compliance and safety.
• Work with upper management to prepare and update compliance policies and procedures.
• Collect and analyze compliance data with upper management and develop improvement plans as needed.
• Assist with SOP development and implementation.
• Support tracking, reporting, and responses to deviations.
• Prepare documentation and responses for audits.
• Prepare, compile, trend, analyze, and present data to support quality-improvement recommendations.
• Maintain records and interpret viable and non-viable sampling results, documenting deviations and explanations for audit review.
• Collaborate on developing and completing employee training at intervals consistent with current standards.
• Work with compliance and operations teams to ensure required SOPs and policies are in place for sterile and non-sterile compounding quality assurance programs.
• Collaborate with operations to develop, complete, audit where applicable, and annually review quality assurance program activities.
• Maintain records, audits, and competencies related to compounding in accordance with regulatory and legal requirements.
• Assist in defining strategy and direction in accordance with national standards and organizational policies and procedures.
• Provide subject-matter expertise and guidance on USP standards and recommend improvements to quality assurance programs.

Benefits

• Comprehensive health coverage, including medical, prescription, infertility, and transgender health services.
• Paid time off, including vacation accrual from day one, sick leave, holidays, and a personal day.
• 401(k) plan.
• Healthcare and dependent care spending accounts.
• Employer-paid life, AD&D, and long-term disability coverage, with optional supplemental plans.
• Tuition assistance.
• Fitness resources.
• Employee assistance.
• Commuter benefits.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level
• Education Level: Ph.D. or professional degree