Medical Laboratory Scientist

Full-Time (dayshift), Monday - Friday
$5,000 Sign-On Bonus
$60,00 - $85,000 DOE
Location: Belgrade, MT
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/Medical Laboratory Scientist that will support the company operation to market regenerative medicine products and medical devices. This position is responsible for a variety of 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 Director of Laboratory Operations and is responsible for communicating effectively with other individuals within the QA/QC, Diagnostics Laboratory, and Biologics departments.
Education/Knowledge/Skills Required

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

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

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
This position does not offer current or future H-1B Visa Sponsorship
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.