Maria Leone

Supervised Environmental Monitoring (EM) activities at Element Concord, ensuring GMP, FDA, and safety compliance, timely testing, and client satisfaction. Managed EM scheduling for technicians and clients, coordinating staffing, sampling activities, site visits, and cleanroom monitoring and cleaning operations to ensure efficient workflow and regulatory readiness.

Performed and supported environmental monitoring at client facilities, including viable and non-viable air, surface, water, gas, settling plates, and fill monitoring in accordance with SOPs and regulatory standards. Oversaw in-house cleanroom operations, contamination control, and gown qualification programs, including aseptic gowning training.

Maintained GMP-compliant documentation and supported quality system activities, including preparation of SOPs, protocols, deviations, and CAPAs. Provided training, mentoring, and operational oversight for EM personnel while supporting process improvements, client communication, and field sampling activities.

• Performed microbiology and environmental monitoring laboratory duties, including air sampling in cleanroom environments while adhering to aseptic gowning procedures and GMP requirements. Collected and tested microbial water samples, including performing bioburden testing on water collected at client facilities. Conducted routine microbiological analyses such as plate counts and documented results in laboratory test records. Followed FDA GMP guidelines, safety protocols, and quality standards to ensure compliance and reliable reporting.

• Performed environmental monitoring in ISO 5, 7, and 8 classified areas, including surface sampling, viable and non-viable air monitoring, and settling plates in isolators using SAS, Climet, and Met-One equipment in compliance with cGMP and aseptic techniques. Conducted water sampling and microbiological testing, including incubation, enumeration, and streaking of microbial cultures to generate viable EM results. Certified aseptic gowning for manufacturing personnel and served as a qualified trainer for EM operations and gowning qualification in aseptic environments. Coordinated EM sampling schedules with manufacturing teams to support production activities. Maintained GMP-compliant documentation, laboratory records, and oversight of laboratory supplies and media inventory.

Ordered, received, and administered medications in accordance with facility protocols. Audited and maintained medication carts to ensure accuracy, safety, and compliance. Monitored resident conditions by taking vital signs, responding to medical emergencies in the absence of nursing staff, and providing first aid as needed. Communicated resident status updates to medical personnel and family members.

Assisted residents with activities of daily living, including bathing, grooming, dressing, feeding, and meal assistance. Provided compassionate, hands-on care to support resident comfort, safety, and overall well-being while maintaining adherence to care plans and facility standards.