Pharmacy Quality Assurance Coordinator

NYU Langone Hospitals; New York, Northern (NY, KY); Hybrid; USD 70,000 - 122,000; Full time

Job summary

NYU Langone Health invites applications for a Pharmacy Quality Assurance Coordinator. The role requires reading and interpreting microbiological, environmental, end-product, and sterile product test results, and reporting findings to senior leadership to ensure USP compliance across the system.

The candidate will design and implement QA policies, train staff, and oversee sterile compounding QA across NYU Langone Health’s facilities, ensuring high quality standards and regulatory compliance.

Qualifications

• Must have strong leadership and team-direction abilities.
• Deep understanding of quality assurance and USP regulations.
• Ability to analyze test results and apply findings to improve processes.
• Excellent attention to detail and meticulous documentation.
• Strong communication with pharmacy staff and leadership.

Responsibilities

• Develops and implements training programs for sterile product compounding quality.
• Ensure compliance with USP <800>, <797>, <795>, and related standards.
• Coordinate product recalls, quarantines, and corrective actions.
• Lead education for staff on USP regulations and quality standards.
• Review daily lab results and report to pharmacy leadership.
• Maintain and troubleshoot QA software/hardware and SOPs.

Education

Bachelor’s or Master’s degree in microbiology, biology, biochemistry, or chemistry

Job description

NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. For the fourth consecutive year, Vizient Inc. ranked NYU Langone No. 1 for quality care in the nation and U.S. News & World Report recently placed 12 of its clinical specialties among the top 10 in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across 6 inpatient locations, its Perlmutter Cancer Center, and over 320 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise with over $1 billion in active awards from the National Institutes of Health.

For more information, go to NYU Langone Health, and interact with us on LinkedIn, Glassdoor, Indeed, Facebook, X, YouTube and Instagram.

For the fourth consecutive year, Vizient Inc. ranked NYU Langone No. 1 for quality care in the nation and U.S. News & World Report recently placed 12 of its clinical specialties among the top 10 in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across 6 inpatient locations, its Perlmutter Cancer Center, and over 320 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise with over $1 billion in active awards from the National Institutes of Health.

NYU Langone Health is a fully integrated health system that consistently achieves the best patient outcomes through a rigorous focus on quality that has resulted in some of the lowest mortality rates in the nation. For the fourth consecutive year, Vizient Inc. ranked NYU Langone No. 1 for quality care in the nation and U.S. News & World Report recently placed 12 of its clinical specialties among the top 10 in the nation. NYU Langone offers a comprehensive range of medical services with one high standard of care across 6 inpatient locations, its Perlmutter Cancer Center, and over 320 outpatient locations in the New York area and Florida. With $14.2 billion in revenue this year, the system also includes two tuition-free medical schools, in Manhattan and on Long Island, and a vast research enterprise with over $1 billion in active awards from the National Institutes of Health.

Position Summary: We have an exciting opportunity to join our team as a Pharmacy Quality Assurance Coordinator. In this role, the successful candidate This position requires a professional level of knowledge to read, interpret, and report microbiological test results, environmental monitoring test results, end product test results, and test results from sterile product room staff. Incumbent will accurately analyze, and summarize results for use by the senior pharmacy leadership team to determine that the pharmacy sterile products service is meeting national quality standards and is meeting United States Pharmacopeia standards for compounding sterile products. The incumbent will be responsible for design and implementation of all quality assurance policies, standards and performs all tests in accordance with the pharmacy departments standard operating procedures. The position requires working independently in a highly efficient and organized manner to ensure accuracy of results and reports. The incumbent must demonstrate a high level of expertise in United Stated Pharmacopeia (USP) chapters <800>, <797>, <795>, <85>, <71> and other areas of the pharmacy. Incumbent will be responsible for training and managing staff compliance with all pertinent USP regulations. The incumbent will be responsible for overseeing compliance of all sterile compounding areas throughout the NYU health system.

Job Responsibilities:

• Develops and implements training programs and competency assessments designed to ensure a high level of expertise in the compounding of sterile products to pharmacy personnel. Responsible for advising the chief of service on all quality matters related to the preparation of sterile products and will be responsible for evaluating pharmacy staff members understanding of and compliance with pharmacy standard operating procedures and with knowledge and understanding of all chapters of USP regulations.
• Skills Required1. Must be able to perform as a leader providing direction and guidance to less experience personnel with regards to quality assurance and all USP regulations.2. Must have a comprehensive understanding of test principles, equipment and its operation, maintenance and repair.3. Must have a high level of analytical ability and judgment to relate test results to normal or pathological states, to resolve technical problems, and interpret quality control data.4. Must possess visual acuity to distinguish fine gradations of color and/or texture, and manual dexterity sufficient to work with delicate machinery.5. Must have the ability to work independently, evaluate situations, and act appropriately.6. Must possess interpersonal skills to interact courteously and effectively with co-workers, clinicians, other hospital personnel and other outside vendors.7. Must have neat and orderly work habits.8. Must have the ability to pay careful attention to detail and to adhere to written protocols.9. Must be able to maintain an appropriate level of professionalism in stressful situations.
• Performs all other duties as necessary.
• Responsible for assuring full compliance with The Joint Commission standards related to sterile product quality assurance, quality control and compliance with NYU pharmacy and hospital policies.
• Leads departmental continuing education for pharmacy department staff regarding state and federal regulations in regards to all chapters of USP, state and FDA regulations as well national quality assurance standards of practice
• Takes responsibility for coordinating any necessary product recall, product quarantining or replacement of products based on testing results and initiates departmental communication.
• Manages the pharmacy quarantine program.
• Develops and maintains competency assignments and schedules.
• Responsible for quality control, quality assurance, problem solving, error review and regulatory compliance for all actions related to sterile product preparation.
• Reviews daily laboratory result reports, communicates results to pharmacy leadership team. Initiates appropriate action when evidence of contamination or improper preparation is received.
• Maintains and trouble shoots all software and associated hardware as needed.
• Creates and maintains the pharmacy departments Standard Operating Procedures for the quality assurance program
• Works in conjunction with all vendors associated with the quality assurance program. This includes vendor specific websites, site visits, and follow-up for customer service issues.
• Responsible for microbial environmental testing of air, surfaces and personnel as outlined in USP chapters, <800> and <797>.
• Responsible for conducting various USP quality assessment, and staff competency assessment tests and analyzing and recording results in a pharmacy database for all sterile products or other medication admixtures subject to quality assurance testing.
• Maintains thorough knowledge of technical advances and developments in quality assurance in the field of pharmacy and microbiology.

Minimum Qualifications: To qualify you must have a Bachelors or Masters Degree in microbiology, biology, biochemistry, or chemistry from an accredited college or university. Two years of microbiology laboratory experience

Preferred Qualifications: American Society for Clinical Pathology (ASCP) certified. May be certified as a generalist or in microbiology only.

Qualified candidates must be able to effectively communicate with all levels of the organization.

NYU Langone Health provides its staff with far more than just a place to work. Rather, we are an institution you can be proud of, an institution where you'll feel good about devoting your time and your talents.

At NYU Langone Health, we are committed to supporting our workforce and their loved ones with a comprehensive benefits and wellness package. Our offerings provide a robust support system for any stage of life, whether it's developing your career, starting a family, or saving for retirement. The support employees receive goes beyond a standard benefit offering, where employees have access to financial security benefits, a generous time-off program and employee resources groups for peer support. Additionally, all employees have access to our holistic employee wellness program, which focuses on seven key areas of well-being: physical, mental, nutritional, sleep, social, financial, and preventive care. The benefits and wellness package is designed to allow you to focus on what truly matters. Join us and experience the extensive resources and services designed to enhance your overall quality of life for you and your family.

NYU Langone Health is an equal opportunity employer and committed to inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration. We require applications to be completed online.

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NYU Langone Health provides a salary range to comply with the New York state Law on Salary Transparency in Job Advertisements. The salary range for the role is $70,481.61 - $121,580.64 Annually. Actual salaries depend on a variety of factors, including experience, specialty, education, and hospital need. The salary range or contractual rate listed does not include bonuses/incentive, differential pay or other forms of compensation or benefits.