Who we are:
WuXi AppTec is a global leader in the pharmaceutical, biopharmaceutical, and medical device industries. The Minnesota site in particular, is a rapidly growing global leader in the medical device testing industry, focusing on pre-clinical testing.
The work we do and why we do it:
Prior to medical devices (everything from bandages to advanced implantable devices such as a pacemaker) being used by patients and medical care practitioners, our clients must prove to regulatory agencies around the world, that their newly created medical devices have been demonstrated safe in our pre-clinical tests. Upon successful completion of pre-clinical testing, our clients work with regulatory agencies on moving to the next step in the process, human clinical trials. Because of our unique business model in specialized pre-clinical testing, we are able to test medical devices during their R&D cycle, and often times see new medical devices years before they are visible and available to the public.
The Sample Receipt Coordinator within the Sample Receipt laboratory is critical to the overall success of the organization. The Sample Receipt laboratory receives the medical devices and associated test requests. They initiate the chain of custody for these materials. This chain of custody will allow for traceability of the medical devices throughout their entire testing lifespan. There are three main functions within the Sample Receipt lab:
Receipt of Test Articles (Medical Devices): Upon receipt of the medical devices (referred to as “test articles”), the Sample Receipt Coordinator will review the submission paperwork in tangent with the test articles themselves. An extremely high level of attention to detail is required to ensure that any discrepancies between the paperwork and the test articles are caught at this stage. Any discrepancies are later communicated to the client and clarified via email or conference call.
Login and Traceability of Testing Received: The Sample Receipt Coordinator will create a unique study number for each testing submission submitted by the client. This study number is created in an electronic chain of custody module. Within this study number, individual inventory will be created to represent each device submitted by the client. The device specific information will also be entered into this system. Labels can then be generated and are used to properly label and identify the material received.
Creation of Study Folders: Once the submission and applicable test articles have been logged into the chain of custody module, a separate study folder will be created for each test that is requested. This folder will contain the submission form submitted by the client, any additional instructions provided by the client, the protocol template (if applicable), and any relevant communication with the client. This folder will go to the study director for review and guide the lab technicians on how to prepare, extract, and test these devices during the testing life cycle.
This position is responsible for logging in and maintaining traceability of all types of Test and Control/Comparison articles submitted on WuXi AppTec submission forms in compliance with GLP, GMP, and ISO standards. This position is also responsible for assembling physical study folders and communicating directly with clients about testing discrepancies. This position requires an understanding of Good Laboratory Practices and Good Manufacturing Practices (WuXi AppTec will provide training as needed).
Experience / Education
Knowledge / Skills / Abilities:
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.