Bio-Manufacturing Support Tech

Reports to: Bio-Manufacturing Support Team Lead

• Job Summary

This position will perform activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person reports to and will support the activities of the Bio-Manufacturing Support Team Lead and Supervisors. This position interacts with employees in the Tissue Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.

• Supervisory Responsibilities
  • This position does not supervise others or teams
• Duties and Responsibilities
  • Develop and maintain an understanding of relevant industry standards and regulations including but not limited to 21 CFR 820, 21 CFR 1271, AATB, MDSAP (per jurisdictional requirements), and ISO 13485, ensuring compliance with these requirements across the organization.
  • Actively contribute to the fulfillment of Xtant Medical’s mission, values and quality policy
  • Maintain a safe, clean work environment and ensure proper disposal of hazardous and non-hazardous waste according to OSHA guidelines and Xtant Medical standard operating procedures (SOP)
  • Develop and maintain an understanding of Xtant Medical products
  • Understand the interaction of departmental activities with the Quality System and their impact on the production of medical devices and human cells, tissues, and cellular and tissue-based products (HCT/Ps)
  • Adhere to Xtant Medical SOPs, Good Documentation Practices (GDP), and safety protocols
  • 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 with error investigations, and resolution, within the quality system
  • 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
  • Operate, monitor, and maintain autoclaves in accordance with the manufacturer’s recommendations and equipment-specific SOPs
  • Transport unprocessed 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
  • Responsible for decontamination, disinfection, cleaning, and sterilization (where appropriate) of all non-disposable processing instruments and equipment
  • Manually wash processing instruments and equipment according to Xtant SOPs
  • Ensure all reusable tissue processing equipment and instruments are suitable for use, including inspection and assembly if applicable
  • Prepare relevant donor processing documentation, labels, and other consumable supplies for sterilization
  • Aseptically introduce equipment and supplies into the cleanroom environment
  • Safely operate, monitor, and maintain cleaning and sterilization equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicable
  • Safely prepare and handle cleaning reagents and solutions according to SDS and SOPs and follow OSHA blood borne pathogen standards,…