Bio-Manufacturing Technician I - 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.

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, and ISO 13485, ensuring compliance with these requirements across the organization.
• 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).
• 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 bloodborne 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.

Required Skills/Abilities

• Must be willing to acquire knowledge of FDA, ISO, and AATB regulations, as applicable.
• Develop an understanding of aseptic techniques and practices.
• Demonstrate capability to communicate effectively both orally and in writing.
• Ability to multitask and manage time efficiently.
• Ability to analyze information to draw relevant conclusions.
• Adapt to quickly changing priorities and schedules.
• Must possess excellent organizational skills and strong attention to detail.
• Must be able to reason independently and work with minimal guidance.
• Basic computer skills are required, such as knowledge of MS Word, Excel, PowerPoint, Outlook, and other software as necessary.
• Some experience with records maintenance and document control preferred.

Education & Experience

• High school diploma required.
• Two (2) year degree or more in the Physical or Life Sciences, Healthcare, or Engineering is a plus or equivalent advanced training/certifications and experience.
• Willing to acquire Certified Tissue Bank Specialist (CTBS) certification.
• Knowledge of human anatomy preferred.
• Knowledge and experience in biologics manufacturing or other relevant cleanroom/aseptic environments preferred, but not required.