The LifeNet Health mission is simple: Saving Lives. Restoring Health. Giving Hope. Its mission, along with its core values of safety, quality, innovation and service continue to create an unmatched record in transplant solutions, which cannot be achieved without talented, dedicated team members who share the same values and attributes that guide the LifeNet Health team every day.
If you have a commitment to customer care, quality and innovation as well as integrity and passion, then you've come to the right place.
We are currently seeking a Manager, Environmental Monitoring to join the LifeNet Health team in our Virginia Beach, VA location.
As a Manager, Environmental Monitoring, you would oversee LifeNet Health's Environmental Monitoring Program, ensuring that all facilities meet regulatory and accreditation requirements. The Manager serves as operational liaison for technical matters, non-conformances, audits and inspections, and conducts personnel administrative duties. The Manager ensures operational effectiveness of the laboratory information system in area of responsibility.
You would be expected to perform all tasks assigned to you, including but not limited to:
Develops and maintains an environmental surveillance program for LifeNet Health's multiple controlled processing facilities. This may include water, surface, and personnel monitoring and viable & nonviable testing.
Oversees receipt of samples, testing, and records associated with Environmental Monitoring (EM); monitors testing, records, and quality systems to ensure compliance with regulatory and accreditation requirements. Performs trend analysis and reporting of EM data. Initiates, investigates, and resolves non-conformances and complaints via LifeNet Health's CAPA system.
Designs and implements procedures and operational protocols. Writes and revises departmental SOPs, policies, and technical reports. Coordinates validation of cleaning, new processes, new equipment, and new facilities.
Develops and presents educational and training programs. Oversees and maintains documentation of training for laboratory & production staff, ensuring that personnel are qualified and competent. Performs administrative functions for laboratory personnel, including but not limited to coordination of work assignments, coaching, counseling and performance review.
Serves as a subject matter expert for EM-related quality assurance, quality control, validation, and regulatory concerns for LifeNet Health and its clients and partners.
Ensures operational effectiveness of the laboratory information system in area of responsibility.
Certified tissue Bank Specialist (CTBS): Achieve certification within 2 years of time in position and maintain throughout employment in this position
Minimum 4 years' experience in Cleanroom Environmental Monitoring, Aseptic Technique
Minimum 3 years' experience Staff management, development, hiring, and performance
Regulatory & Compliance Knowledge of regulation/ accreditation policies governing tissues and medical devices (FDA, AATB, ISO)
Validation: Cleaning, Recovery Efficiency, Neutralization
Laboratory Information Systems (LIS): Knowledge of LIS database design, configuration, validation
Business Management: Knowledge of accounting, materials management, planning
Personnel Management: Knowledge of scheduling, staffing, hiring, performance management, training & development
Decision Making: Ability to use complex reasoning to make decisions that may have interdepartmental scope/effect
Interpersonal: Negotiation/conflict management, effective teamwork, effective communication at different organizational levels
Regulatory & Compliance Knowledge of Environmental Monitoring regulations (U.S. and EU)
Get to Know LifeNet Health:
LifeNet Health, headquartered in Virginia Beach, Virginia, is the largest nonprofit organ procurement organization ("OPO") and tissue bank in the United States, as well as a leading innovator in transplantation research and regenerative medicine. LifeNet holds the longest running current accreditation by the American Association of Tissue Banks (AATB). Its goal is to improve the quality of human life through the provision of organs and tissues for transplantation, as well as innovation in the fields of bio-implants and regenerative medicine, and to serve the community with educational and support services that enhance the donation process.
We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing. #LI-AF1