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The System Environmental Monitoring Specialist serves as the enterprise subject matter expert for environmental monitoring across Beth Israel Lahey Health's pharmacy sterile compounding operations. The role oversees and coordinates environmental monitoring activities across all BILH hospitals, infusion pharmacies, and sterile compounding locations to ensure compliance with USP <797>, applicable state and federal requirements, accreditation standards, and BILH policies.Job Description:
Essential Responsibilities:
1. Acts as the primary environmental monitoring subject matter expert for the health system and provides consultation, technical interpretation, and regulatory guidance to Directors of Pharmacy, Designated Persons, Quality Leaders, and hospital leadership regarding environmental monitoring requirements, contamination-control strategies, excursion management, investigation findings, remediation activities, and regulatory expectations. Supports decision-making affecting sterile compounding operations across all BILH hospitals and pharmacy entities.
2. Coordinate and perform routine, non-routine, and event-driven environmental monitoring across ISO-classified sterile compounding facilities, including viable air sampling, nonviable particulate monitoring, surface sampling, personnel monitoring, and cleanroom condition assessments such as pressure differentials, airflow, and facility controls.
3. Prepare, label, package, transport, and submit environmental monitoring samples for internal or external laboratory analysis while maintaining sample integrity, traceability, and full chain-of-custody documentation.
4. Maintain accurate, complete, and inspection-ready environmental monitoring records in accordance with regulatory requirements and system policies; identify and escalate documentation discrepancies requiring follow-up.
5. Maintains enterprise-wide oversight of environmental monitoring data across all hospitals and sterile compounding sites; develops system-level dashboards, performance indicators, and risk assessments; evaluates trends and emerging risks; and communicates findings and recommendations to pharmacy leadership to support proactive quality and compliance initiatives.
6. Participate in investigations of excursions, deviations, OOS results, and other quality events by compiling and evaluating environmental, personnel, facility, cleaning, certification, and historical monitoring information; support contamination-source analysis, root cause determination, CAPA development, and remediation effectiveness.
7. Serve as a technical resource for EM activities and collaborate with pharmacy leadership, designated persons, site personnel, microbiology laboratories, certification professionals, facilities teams, infection prevention, and quality groups regarding sampling activities, findings, investigations, and follow-up actions.
8. Manage inventory, verification, and distribution of EM media, reagents, supplies, and equipment, including checks of lot numbers, expiration dates, growth promotion documentation, calibration status, maintenance needs, and proper storage conditions.
9. Maintain readiness of EM equipment and materials by coordinating calibration, preventive maintenance, and replacement needs across the system.
10. Coordinate EM schedules and activities with site pharmacy teams to ensure timely completion of routine, non-routine, investigational, and repeat monitoring while minimizing disruption to sterile compounding operations.
11. Leads standardization of environmental monitoring practices, workflows, data-management processes, quality metrics, investigation methodologies, and reporting requirements across all BILH sterile compounding locations. Collaborates with Directors of Pharmacy and system leadership to implement best practices, strengthen regulatory compliance, and ensure consistent execution of environmental monitoring activities throughout the enterprise.
12. Contribute to the development and expansion of the health system’s EM program and team by adopting new processes, supporting evolving structures, and helping standardize practices across all sites.
13. Maintain proficiency in EM procedures, aseptic practices, contamination control, sampling equipment, data management, and applicable regulatory and organizational requirements through required education, training, and competency assessments.
14.Perform additional QC microbiology or contamination-control tasks as needed and other duties as assigned.
Required Qualifications:
1. High School diploma or GED required.
2. Pharmacy Technician Registration or Licensure in good standing with the Massachusetts Board of Registration in Pharmacy, or the ability to obtain registration upon hire, required.
3. National Pharmacy Technician Certification within six (6) months of hire
4. Minimum of five (5) years of experience in sterile compounding, microbiology, environmental monitoring, cleanroom operations, or another directly related controlled-environment or laboratory setting.
5. Ability to travel to all BILH Pharmacy locations as required.
6. Demonstrated attention to detail, organizational skills, and ability to accurately perform and document technical activities.
7. Demonstrated ability to understand and apply technical procedures, quality standards, and regulatory requirements within a controlled or regulated environment.
Preferred Qualifications:
1. Compounded Sterile Preparation Technician (CSPT) certification
2. Associate's or bachelor's degree in microbiology, biology, chemistry, or another related life science.
3. Experience performing environmental monitoring activities, including viable air sampling, nonviable particle monitoring, surface sampling, and/or personnel monitoring.
4. Experience with microbiological media handling, sample preparation, incubation, colony enumeration, or other microbiological laboratory processes.
5. Working knowledge of USP <797>, USP <800>, aseptic technique, contamination control principles, and cleanroom operations.
6. Experience maintaining technical or quality records in accordance with established procedures and regulatory requirements.
7. Experience using Microsoft Excel or other data-management systems to organize, trend, analyze, and interpret environmental or quality data.
Competencies:
Decision Making: Ability to make decisions guided by established procedures, workflows, policies, and program goals. Seeks guidance for complex, urgent, clinical, or out-of-scope situations.
Problem Solving: Ability to identify patient barriers, workflow issues, access concerns, and documentation gaps using available information and established procedures.
Independence of Action: Ability to organize daily work, manage assigned outreach and follow-up tasks, and complete responsibilities within general guidelines. Work progress is monitored by ambulatory care pharmacists, supervisors or managers.
Written Communications: Ability to communicate clearly and effectively in written English with internal and external customers. Accurately documents patient communication, care coordination activities, and follow-up needs.
Oral Communications: Ability to comprehend and communicate information in English to patients, families, pharmacists, clinic staff, providers, pharmacies, payers, and external partners.
Knowledge: Ability to demonstrate working knowledge of standard pharmacy, ambulatory care, population health, medication access, patient navigation, and documentation workflows.
Team Work: Ability to work collaboratively with ambulatory care pharmacists, ambulatory clinic teams, medication access teams, case managers, pharmacies, payers, and other stakeholders to support patient care coordination and program operations.
Customer Service: Ability to provide high-quality service to patients, families, staff, and external customers in a professional, respectful, and service-oriented manner.
Pay Range:
$104,000.00 USD - $141,440.00 USDThe pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.
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