Summary:

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 honor the gift of donation, by allowing our patients to live as full, and complete a life as possible.

Position Summary

Xtant Medical is seeking a talented and dedicated Clinical Laboratory Scientist that will support the company operation to market regenerative medicine products and medical devices.  This position is responsible for a variety of Clinical Laboratory procedures/tests with an emphasis on microbiology, infectious disease testing, maintaining logs/records, training employees, and managing the day-to-day operations of the Diagnostics Laboratory. This position may provide additional support to the Biologics department. This position reports to the Clinical Laboratory Manager or Supervisor and is responsible for communicating effectively with other individuals within the QA/QC, Diagnostics Laboratory, and Biologics departments.

Principle Duties & Responsibilities

• Support Xtant Medical’s mission to honor the gift of donation, by allowing our patients to live as full, and complete a life as possible
• Perform all necessary testing procedures for both microbiology and serology used in the identification and/or detection of pathogenic microbes and infectious disease
• Document and evaluate quality control specimens to determine the acceptability of sample results
• Perform and document all quality control procedures as required by CLIA
• Perform and document any maintenance or troubleshooting as needed
• Adhere to Xtant Standard Operating Procedures (SOPs) and safety protocols, FDA Regulations for Human Cells, Tissues, and Cellular and Tissue-Based Products (HCT/Ps) and Devices; operate in compliance with FDA, AATB, ISO, and Occupational Safety and Health Administration (OSHA) Standards
• Perform all duties according to SOPs and Good Documentation Practices (GDP) and follow appropriate safety policies and universal precautions
• 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 of Standardization (ISO); and Clinical Laboratory Improvement Amendments (CLIA), as applicable, and adhere to standards and regulations to help the company lead the Medical Device and Biologics industries in quality practice
• Develop and maintain an understanding of the Xtant products and general biological and chemical systems utilized within the Department. Know how the activities performed in the Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
• Write, review, and revise a variety of technical documents including SOPs (Standard Operating Procedures), Work Instructions, and laboratory procedures as needed
• Assist in the completion and retention of documentation pertaining to all SOPs as required
• Legibly and accurately complete all documentation associated with assigned duties in accordance with current GDP and review the information of others as required

Position Requirements

• Aware of Good Laboratory Practices (GLP) and Quality System Regulation (QSR)
• knowledge of CLIA, FDA, ISO, and AATB requirements
• Must be familiar with laboratory processes and procedures
• Proven ability to write, review, and edit technical SOPs
• Advanced ability to communicate effectively both orally and in writing and the ability to present effectively to small and large groups
• Ability to multitask
• Excellent organization skills needed
• Proficient computer skills required such as knowledge of MS Word, Excel, PowerPoint, Access and Outlook
• Must possess excellent organizational skills and strong attention to detail
• Ability to investigate and analyze information and draw conclusions
• Some experience with records maintenance and document control preferred
• Must be able to reason independently and work with minimal guidance
• Ability to interpret data and make sound judgments based on those interpretations
• Must deal effectively with a wide variety of personalities and situations requiring tact, judgment, and poise
• Must be able to adapt to quickly changing priorities and schedules
• Ability to maintain good working relationships with all co-workers and the general public and use good judgment in recognizing scope and authority
• Must possess mobility to work in standard office and laboratory settings and use standard office equipment

Education/Knowledge/Skills Required

• Bachelor’s degree from an accredited college or university in Clinical Laboratory Science (or equivalent) is required
• Two (2) years’ prior Clinical Laboratory Scientist experience preferred
• Must have or be able to obtain a valid Montana CLS License
• Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification

Working Conditions

• Working conditions are normal for an office environment, laboratory setting, environmentally controlled area (ECA), cleanrooms, and other sterile environments. Standard office hours are Monday – Friday; 8:00 am – 5:00 pm. Work will require occasional weekend/evening work
• Work may require long periods of sitting, standing, and working at a computer
• Duties may include contact with human tissue, blood, bone, and fluids (Clinical Laboratory, Donor Services, Engineering, Processing, Packaging and Labeling, etc.). Working in PPE such as cleanroom suits, with face shields and masks as necessary

Benefits: Xtant Medical offers competitive wages, and comprehensive Medical, Vision, Dental, 401k, Life and AD&D, and Disability insurance packages

 No H1B Sponsorships Available for this Position

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.