Bio-Manufacturing Technician II - Processing

Overview

Status: Full Time, Non-exempt

Reports To: Processing Team Lead

A. Purpose and Scope of Position

This position will perform activities related to donor tissue processing while maintaining quality and regulatory compliance within their department. This person does not supervise others and will support the activities of the Processing Team Lead(s) and Supervisors. This position interacts with employees in the Processing Department and may interact with other department supervisors, team leads, and personnel as necessary.

B. Organizational Relationship

This position reports to the Processing Team Lead or Supervisor. This position may provide additional support to other team leads, supervisors, or departments as requested.

C. Duties and Responsibilities

1. Specific Job Duties/Responsibilities

• 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 for Standardization (ISO) 13485, European Medical Device Directives (MDD), Canadian Medical Device Regulations, Occupational Safety and Health Administration (OSHA), and other regulatory standards as applicable
• Adhere to all Xtant Standard Operating Procedures (SOPs) and safety protocols while operating in compliance with regulatory standards
• Develop and maintain an understanding of Xtant products and general biological and chemical systems utilized within the Processing Department. Know how the activities performed in the Processing Department are controlled by and interact with the Quality System and how they affect the production of medical devices and tissues as applicable
• Support the Xtant mission to design, manufacture, and distribute innovative, safe, reliable, and cost-effective solutions for the medical needs of patients
• Maintain a clean and safe working environment at all times and follow requirements to properly dispose of hazardous and non-hazardous waste according to OSHA regulations and Xtant SOPs
• 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
• Assist with error and nonconformance investigation within the quality system
• Accurately enter appropriate donor and graft information into material tracking reports
• Assist in donor tissue and material movement
• Support stored tissue inventory and record keeping tasks
• Must maintain confidentiality of donor and recipient information
• Provide recovery agency feedback on tissue quality
• Upon hire, employee will rotate through processing support teams in order to learn various tasks associated with production and donor processing.
• Provide assistance and support to other teams, departments, team leads, and supervisors as requested

2. Financial Responsibilities

• Submit timely expense reports and abide by the Expense Reimbursement Policy

3. Training

• Responsible for participating in training plans and programs and completing assigned training in a timely manner within set deadlines
• Complete all required training prior to attempting to perform a task
• Maintain accurate and detailed training documentation. Ensure training is up to…