Packaging & Labeling Technician

Reports to: Packaging & Labeling Team Lead

• Job Summary

This position will perform activities related to production, product design and development, quality, and regulatory compliance in their department as assigned. This position interacts with employees in the department and may interact with other department supervisors, team leads, and employees.

This position works with the department team lead(s) and manager and with other technicians at the research and development or production and processing level to help ensure that Xtant Medical complies with and meets the standards of the Food and Drug Administration (FDA), Association for Advancing Tissue and Biologics (AATB), International Organization of Standardization (ISO) 13485, and other regulatory agencies 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
  • Follow OSHA Blood Bourne Pathogen Standards, Universal Precautions, AATB Standards, current Good Manufacturing Practices (cGMP), and current Good Tissue Practices (cGTP)
  • Clean, maintain, and operate instruments and equipment as needed
  • Assist in the Quality Control (QC) functions of examining and inspecting labels and finished good products to ensure that packaging specifications are met as required by SOPs
  • Maintain a basic knowledge of how to navigate through the Processing paperwork to establish and assign expiration dates for processed tissue and devices according to SOPs
  • In a team environment, assist in the completion of the department’s sterilization processes for product and raw materials
  • Learn and maintain the knowledge of Xtant Medical product lines and the product codes that are associated with them
  • Be able to use equipment such as Industrial label printers and sealers, and common office equipment
  • Assembles finished good products with designated labeling materials and print labels using barcode software
  • Coordinate the shipping and receiving of materials as needed
  • Assist in maintaining appropriate inventory levels and materials management within ERP software
  • Operate Fed Ex and UPS shipment manager software to generate labels and documents
  • Communicate with Customer Service and other departments as needed
  • 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
  • May require OSHA (blood borne pathogen) training, SDS, and other safety training as applicable
  • May require experience or training in the routine handling of chemicals and biohazards
• Document Control…