The Study Director has overall responsibility for the technical conduct of all assigned tests as well as for the review, interpretation, analysis, documentation, and reporting of results. The study director is the single point of study control. The study director ensures all assigned studies are completed on time.
Section: Healthcare Reprocessing
Nelson Labs offers a full range of medical device cleaning, disinfection and sterilization validation services to validate manufacturers' reprocessing instructions for reusable devices. This is essential to ensuring that medical devices processed in a health care setting are safe for their intended use or reuse. This role would include mimicking contamination on reusable devices from a small as scalpels and or forceps to dialysis machines, ventilators or other large medical devices. Lab Analysts would then run various cleansing methods and test afterward to determine safety and effectiveness.
Education and experience requirements:
B.S. degree in a related Life Science; Biology, Microbiology, Biotechnology, or similarExperience in Laboratory setting conducting controlled studiesThis can be from current/prior employment, or work study through a University or Internship ProgramKnowledge of laboratory testing, equipment, procedures, and basic math sufficient to direct and oversee assigned testingEssential Duties:
Scientific/General
Ensure reports are compliant with current procedures and accurately reflect the data, results, and conclusions of the testingEnsure test controls and monitors are accurately recorded and reviewedCollaborate within the Quality Event (QE) processAct as a final signature for assigned studiesRegulatory Compliance
Know and follow applicable regulatory requirements (GMP, GLP, ISO, etc.).Ensure that test procedures are approved, communicated to, and followed by analystsClient Interaction
Communicate regularly with external clientele as needed to relay study updates and logisticsCollaborate with the Sales department on testing quotesCoordinate Project workflow to ensure client expectations are metPhysical requirements:
The physical demands described here are a representative of those that must be met to perform the essential job functions.
Requirements to stand and traverse to various office and lab locations and sit at a computer workstation will vary.Bending, stooping, and crouching.Occasional push and pull tasks with one or both hands.Must be able to work while wearing personal protective equipment such as safety glasses, goggles, face shields, gloves, lab coats and personal protective equipment deemed necessary to protect testing and to protect employees from various solutions, wastes, etc.The name Sotera Health was inspired by Soteria, the Greek goddess of safety, and reflects the Company's unwavering commitment to its mission, Safeguarding Global Health. Sotera Health Company is a leading global provider of mission-critical sterilization and lab testing and advisory services for the healthcare industry. With a combined tenure across our businesses of nearly 200 years and our industry recognized scientific and technological expertise, we help to ensure the safety of millions of patients and healthcare practitioners around the world every year. Across our 64 facilities worldwide, we have over 3,000 employees who are dedicated to safety and quality. We are a trusted partner to more than 5,800 customers in over 50 countries, including more than 40 of the top 50 medical device companies and 8 of the top 10 global pharmaceutical companies.
Sotera Health goesto market through its three best-in-class businesses - Sterigenics, Nordion and Nelson Labs. Sterigenics is a leading global provider of outsourced terminal sterilization and irradiation services for the medical device, pharmaceutical, food safety and advanced applications markets. Nordion is the leading global provider of Co-60 and gamma irradiators, which are key components to the gamma sterilization process. Nelson Labs is a global leader in outsourced microbiological and analytical chemistry testing and advisory services for the medical device and pharmaceutical industries. Learn more about Sotera Health at soterahealth.com.
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