Bio-Manufacturing Technician - Processing

Full Time Technical Belgrade, MT, US

Salary Range: $26.00 To $26.00 Hourly

Classification: Full Time, Non-Exempt

Reports to: Bio-Manufacturing Team Lead
- Processing

• 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 Team Lead
- Processing 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 debriding, shaping, sizing, grinding, milling, demineralizing, labeling, and packaging of human tissue intended for transplantation
  • Know the appropriate storage conditions, locations, and tissue handling methods for unprocessed and processed donor tissue
  • Aseptically set up processing cleanroom, equipment, and supplies for use during processing and packaging procedures
  • Inspect all processing reagents, supplies, instruments, and equipment prior to use to ensure acceptability for use in tissue processing
  • Safely operate, monitor, and maintain processing instruments and equipment in accordance with manufacturer recommendations and equipment-specific SOPs when applicable
  • Safely prepare and handle processing reagents and solutions according to SDS and SOPs and follow OSHA blood borne pathogen standards, Universal Precautions, and current Good Tissue Practices (cGTP) when handling biological material
  • Accurately assign and verify appropriate product codes and dimension/volume specifications
  • Perform in-process Quality Control (QC) as required by Xtant SOPs and the Quality System
  • Accurately enter appropriate donor and graft information into material tracking reports
  • Assist in donor tissue and material movement
  • Provide assistance and support to other teams, departments, team leads, and supervisors as requested
  • Other duties as assigned
• Submit timely expense reports and abide by the Expense Reimbursement Policy
• Training
  • Complete required training, including but not limited to initial orientation and environmental health and safety training prior to performing tasks
  • Participate in training programs, ensuring timely completion and accurate, up-to-date training records
  • Complete annual SOP review and safety training (i.e. OSHA, blood borne pathogens) as applicable
  • Complete Document Read Training (DRT) within required deadlines whenever a document within the Quality System undergoes revision
  • Upon hire, rotate through processing support teams to learn various tasks associated with production and donor processing
  • May require OSHA (blood borne pathogen) training, SDS, and other safety training as applicable
  • May require experience…