To apply for this position, please visit our company Careers Page at https://xtantmedical.com/careers/
Why Xtant Medical?
JOIN A RISING organization that is focused on the design, development, and commercialization of a comprehensive portfolio of orthobiologics and spinal fixation systems. Xtant Medical’s mission is to provide cost-effective technology and services that help clinicians efficiently perform their job.
This position will perform support activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person does not supervise others and will support the activities of the Circulation Team Lead(s) and Supervisors. This position interacts with employees in the Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.
Job Responsibilities and Duties:
- Develop and maintain an understanding of the requirements of the Food and Drug Administration (FDA) Code of Federal Regulations Title 21 Parts 820 and 1271, American Association of Tissue Banks (AATB), International Organization for Standardization (ISO) 13485, European Medical Device Directives (MDD), Canadian Medical Device Regulations, Occupational Safety and Health Administration (OSHA), and other regulatory standards as applicable.
- Adhere to all Xtant Standard Operating Procedures (SOPs) and safety protocols while operating in compliance with regulatory standards.
- Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Processing Department. Know how the activities performed in the Processing Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable.
- Support the Xtant mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients.
- Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant SOPs.
- Responsible for decontamination, cleaning, and environmental monitoring of the cleanroom areas and non-sterile equipment used to process donor tissue.
- Responsible for maintaining inventory of processing supplies/reagents and other materials within the cleanroom environment and other areas throughout the processing facility.
- Ensure supplies are acceptable for processing use and stock is rotated using the First-In First-Out (FIFO) method. Aseptically transfer supplies into the cleanroom environment to maintain adequate inventory and whenever needed.
- Obtain environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocols.
- Assist in the preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facility.
- Operate, monitor, and maintain lyophilizers (freeze-dryers) in accordance with the manufacturer’s recommendations and equipment-specific SOPs
- Transport unprocessed and processed donor tissue across campus.
- Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue.
- Provide facility cleaning support to areas outside of the cleanroom environment
- Must maintain confidentiality of donor and recipient information.
- Provide assistance and support to other teams, departments, team leads, and supervisors as requested.
- High School Diploma or equivalent.
- Willing to acquire Certified Tissue Bank Specialist (CTBS) certification.
- Some familiarity with basic laboratory techniques and equipment is desired.
- Experience in healthcare or medical device production is preferred, but not required.
- Familiarity with aseptic practices and/or experience in sterile environments is preferred, but not required.
- Must be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicable.
- Develop an understanding of aseptic techniques and practices.
- Demonstrate capability to communicate effectively both orally and in writing.
- Ability to multitask and manage time efficiently.
- Must be able to adapt to quickly changing priorities and schedules.
- Must possess excellent organizational skills and impeccable attention to detail.
- Must be able to reason independently and work with minimal guidance.
- Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary.
- Some experience with records maintenance and document control preferred.
Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages
Xtant Medical is an equal opportunity employer. We do not discriminate on the basis of race, color, religion, national origin, sex, age, disability, or any other status protected by law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions be based on job-related factors.