To be part of our organization, every employee should understand and share in the YNHHS Vision, support our Mission, and live our Values. These values - integrity, patient-centered, respect, accountability, and compassion - must guide what we do, as individuals and professionals, every day.
Under the leadership of the Director of Oncology Pharmacy and the Manager, Sterile Compounding Quality and Compliance the Pharmacy Industrial Hygienist is responsible for the coordination and planning of processes that recognize, eliminate and control occupational health hazards related to sterile compounding facilities and the personnel who handle sterile products and hazardous medications within the Yale New Haven Health System. The Industrial Hygenist will ensure that the highest of quality standards are in place coupled with regulatory requirements. In collaboration with pharmacy leadership ,the position will be responsible for developing a robust monitoring, surveillance and audit program to ensure necessary measures and interpretation of documented results and/or excursions related to environmental monitoring, personnel, standard operating policy and procedure, end product testing and corrective action preventive action plans are handled properly. His/her references are the U.S. Pharmacopeia (USP) 797/800/795/825 regulatory standards, YNHHS policies, The Joint Commission accreditation standards (TJC), American Society of Health-Systems Pharmacists, the FDA, CT DPH and DCP and state and federal regulations.
- 1. Coordinates and plans programs that recognize, eliminate and control hazards of medications
- 2. Investigates adequacy of cleanroom ventilation, HVAC exhaust equipment and other conditions that may affect staff health, comfort and efficiency.
- 3. Conducts evaluations of exposure and makes recommendations to ensure employee protection.
- 4. Collaborates with Manager of Sterile Compounding Quality and Compliance to institute control and remediation for hazardous and potentially hazardous conditions and cleanroom equipment.
- 5. Prepares reports including observation, analysis and remediation of actionable contaminants, and makes recommendations for control and corrective actions.
- 6. Participates in Educational meetings with staff that prepare staff in matters pertaining to hazardous and non-hazardous drugs
- 7. Involved with the collection and analysis of environmental samples, both surface and air samples
- 8. Involved with the assessment and control of HD exposures to the environment.
- 9. Involved with the safe handling of hazardous waste
- 10. Provides recommendations to improve and maintain the overall cleanroom operation
- 11. Conducts education and training programs for sterile compounding for inter and intra departmental hospital staff
- 12. Ensures sterile compounding compliance with regulatory agencies including CT DPH, CT DCP, TJC, FDA, CMS and all other state and federal regulatory agencies
- 13. Ensures regulatory compliance with USP 797, USP 800, USP 795 and USP 825
- 14. Develops techniques and strategies that control and anticipate potential problems with sterile compounding
- 15. Maintains the operation, calibrating of monitoring and sampling equipment
- 16. Serve as a subject matter expert to assist in identifying and mitigating ongoing risk through review of data and analytics, reviewing day-to-day deviations/excursions/concerns in the quality assurance plans and to remediate in real-time, performing trend analysis to identify possible risk.
- 17. Interprets quality assurance data and collaborates with manager to predict emerging areas of need and adjust monitoring and evaluation strategies quickly and appropriately
- 18. Maintains up-to-date knowledge of industry trends, cutting-edge practices and techniques, current publications and regulations relevant to role and business and seeks advanced knowledge sponsored by national certification programs
- 19. Identifies need for and implements administrative systems to plan for and carry out quality assurance activities and projects in a cost-effective and timely fashion
- 20. Works with manager to ensure proper documentation and filing of all training, environmental monitoring. Follows up with manager-of-record around non-compliance issues
EDUCATION (number of years and type required to perform the position duties):
College graduate, BS Nursing or BS Pharmacist with training in Infection Control or similar experience. Advanced Master's Degree desireable
3-5 years of experience in large-scale/high volume/high demand hospital/system and/or compounding/ manufacturing facility highly preferred
Licensed as Industrial Hygienist, Nurse, Pharmacist or equivalent licensure
Expertise in compliance standards and regulations promulgated by the relevant agencies: DPH, DCP, TJC, CMS, FDA, USP
Must be able to stand or sit for extended periods of time