Bio-Manufacturing Support Technician

2 weeks ago

Belgrade, Maine, United States Xtant Medical Holdings Inc Full time
About the Role

Xtant Medical Holdings Inc is seeking a highly skilled Bio-Manufacturing Support Technician to join our team. As a key member of our production team, you will play a critical role in ensuring the highest quality standards are met in the processing and manufacturing of human tissues for transplantation.

Key Responsibilities
  • Decontamination, cleaning, and environmental monitoring of cleanroom areas and non-sterile equipment used to process donor tissue
  • Maintaining inventory of processing supplies and reagents within the cleanroom environment and other areas throughout the processing facility
  • Ensuring supplies are acceptable for processing use and stock is rotated using the First-In First-Out (FIFO) method
  • Aseptically transferring equipment and supplies into the cleanroom environment
  • Obtaining environmental samples for surface, air, and water monitoring in conjunction with laboratory testing protocols
  • Assisting with the preparation and transportation of soiled processing instruments, equipment, cleanroom garments, and biohazardous waste throughout the processing facility
  • Operating, monitoring, and maintaining cleaning and sterilization equipment, lyophilizers, and autoclaves in accordance with manufacturer recommendations and equipment-specific SOPs
  • Decontamination, disinfection, cleaning, and sterilization (where appropriate) of all non-disposable processing instruments and equipment
  • Ensuring all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly
  • Preparing relevant donor processing documentation, labels, and other consumable supplies for sterilization
  • Safely preparing and handling cleaning reagents and solutions according to SDS and SOPs and following OSHA bloodborne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological material
  • Collecting and preparing soiled cleanroom garments for shipment to vendors
  • Collecting and preparing solid biohazardous waste for shipment in accordance with OSHA standards and Xtant SOPs
Requirements
  • High School Diploma or equivalent is required
  • Must be willing to acquire Certified Tissue Bank Specialist (CTBS) certification
  • Some familiarity with basic laboratory techniques and equipment, aseptic practices is preferred, but not required
  • Experience working in sterile environments, healthcare or medical device production is preferred, but not required
  • Experience with records maintenance and document control is preferred, but not required
  • Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary
  • Must have excellent manual dexterity and good eye/hand/foot coordination
  • Must be able to perform repetitive tasks/motions
  • Must be able to record information legibly by hand
  • Must be able to lift, push, and pull 60 lbs.
Working Conditions
  • Working conditions include normal office environment, environmentally controlled areas (ECAs), cleanrooms, and decontamination areas
  • May require evening work and weekend work
  • May require 4+ hours of continuous standing
  • May work in conditions leading to minor personal discomfort such as in temperatures above or below personal comfort levels
Health and Safety
  • Duties will include direct contact with human tissue, blood, bone, and fluids
  • Must adhere to all health and safety requirements specified when entering processing, device manufacturing areas, and decontamination areas and in the handling of company products
  • This position will be required to wear personal protective equipment (PPE), including but not limited to scrubs, laboratory coat, gloves, face shields, helmets, boot covers, and sterile suits
  • Will require training in the routine handling of chemicals and biohazards
  • Will require OSHA (bloodborne pathogen) training, SDS, and other safety training as applicable
  • Hepatitis B vaccine is highly recommended and provided to employees who may have contact with human tissue at no cost to the employee. Any employee who declines a Hepatitis B vaccine will be required to sign a waiver

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